MediWound Ltd.

and welcome to the MediWound first quarter 2025 earnings call. All participants will be in 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, then one on a touch-tone phone. To withdraw your question, please press star and then two. Please note this event is being recorded. I would now like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead.

Thank you, Operator, and welcome, everyone. Earlier today, pre-market open, MediWound issued a press release announcing financial results for the first quarter ended March 3-1, 2025. You may access this press release on the company's website under the Investors tab. I 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 MediWoon'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 followings with the SEC. In addition, all forward-looking statements represent our views only as of today, and Meadowood assumes no obligation to update or supplement any forward-looking statements, whether a result of new information, future events, or otherwise. This conference calls the property of Meadowood and any recording or rebroadcast is expressly prohibited without the written consent of MetaWound. With us today are Ofer Gonan, Chief Executive Officer of MetaWound, and Hani Luxenberg, Chief Financial Officer. Barry Wolfenson, EVP of Strategy and Corporate Development, is also participating in today's call. Following our prepared remarks, we will open the call for Q&A. Now, I would like to turn the call over to Ofer Gonan Chief Executive Officer of MediWound. Over.

Hey, thank you, Dan, and good morning, everyone. We entered 2025 with strong execution across our clinical, commercial, and operational priorities, maintaining the momentum we established in 2024. The value-based risk study for S-Corex is on track, and the addition of a collaboration with Kerasys marked a significant milestone. actually bringing nearly all the major wound care companies into our clinical research program. Meanwhile, Nexobrit continues to gain global traction as we advance long-term manufacturing investments to support sustained growth. Let's begin with Escarex, our next-generation enzymatic debridement therapy for chronic wounds. Recruitment for the value phase we study for venous leg ulcers is progressing as planned. The global trial will enroll 216 patients across approximately 40 sites in the United States and Europe. Most of the U.S. sites are already open, and the majority of the European sites are expected to be activated in the third quarter of 2025. Our SCRx program is strategically de-risked, building on the strong results of our Phase II studies. If SCRx simply replicates those clinical outcomes, the Phase III trial would be considered a clear success with results expected to support both regulatory submissions and commercial positioning. The value of Phase III protocol also includes key enhancements designed to further increase the likelihood of success. We have a larger patient population to increase statistical power. An interim analysis, 65% enrollment, enabling adaptive adjustments. This assessment is anticipated in mid-2026. And we have standardized treatment protocols to minimize variability and ensure consistency across sites. Finally, it is important to note that S-Correct shares the same FDA-approved active pharmaceutical ingredient as Nexobrid. for nearly identical indication, escar removal. To further strengthen our BLA submission and to enhance commercial readiness, we are planning a 45-patient randomized prospective phase two head-to-head comparison of escarex versus collagenase, scheduled to begin in the second half of 2025. This study will include both Santil and the European collagenase product, Eruxol. generating critical comparative data that will be instrumental in supporting our market access and pricing strategies. This quarter also marks a major milestone in our strategic research collaborations. We now have participation by almost all the leading global wound care companies across our clinical development programs. Added to the list is Kerasys, which will support our upcoming diabetic foot ultrasound trial by providing its tissue product, Merigen. It's a fish skin graft for active closure. With Solventum, Molniki, Keresys, Mimedix supporting our clinical programs, Escarex has received strong external validation from most of the key players in the industry. The growing excitement around Escarex comes from its clear clinical advantages, particularly when we compare it to Santil, the only FDA-approved enzymatic debridement agent. This was further reinforced by a recent peer-reviewed publication in Wood, which included a post-hoc analysis of our Phase II chronic study in VLUs. The data there confirmed Escarex's superiority across multiple endpoints, including faster debridement, enhanced regulation tissue formation, and improved wound closure. The company has secured the 2.5 million euros grant component of the European Innovation Council accelerator funding to support the clinical and regulatory advancements of Escarex for the treatment of diabetic foot ulcers. Following a successful evaluation process, the company engaged in discussions for the 13.75 million euros equity investment which may not be materialized. We don't expect this to impact our timeline. The DFU study remains on track to begin in 2026, pending alignment with both the FDA and EMA on the trial protocol. The rationale for our excitement around the DFU program was clearly demonstrated at recent major international wound care conferences. including the WHS, SAWC, and Yuma. We presented DFU-specific data from our first Phase II study of S-Correct. That study included patients with DFU, VLU, and with trauma wounds, and the DFU results mirrored the strong efficacy we have already seen in VLUs. I will mention a few key findings. Escarx achieved 58% complete debridement compared to just 14% with the gel vehicle. The annulation tissue was observed in 42% of Escarx-treated wounds versus only 11% with the vehicle. The median time to complete debridement was just 23 days for Escarx compared to 128 days with the gel. and the median time to wound bed preparation was 24 days for escarex, whereas it was not achieved at all in the vehicle group. With all this momentum and assuming positive results from the value phase three study, we believe escarex is well positioned to become the global leader in enzymatic wound debridement. Now let's turn our attention to NexoBREAD our innovative enzymatic therapy for severe burns. U.S. adoption of NexoBread continues to expand with consistent ordering from nearly 60 burn centers. Our commercial partner, VeriCell, reported a 207% year-over-year increase and a 31% sequential increase in NexoBread revenue during the first quarter of 2025. In Japan and Europe, demand continues to exceed manufacturing capacity. We remain on track with the commissioning of our new manufacturing facility with operational readiness expected by year-end 2025. Commercial availability will follow regulatory approvals from the FDA and EMA, and it is anticipated in 2026. This facility will significantly expand our production capabilities enabling us to meet growing global demand and support sustained revenue growth. NexoBREAD also featured prominently in recent scientific and clinical communications. Results from a pediatric phase 3 study were published in the peer-reviewed journal Burns, reinforcing NexoBREAD efficacy and safety as a non-surgical eschar removal therapy for both adults and pediatric burn patients. At the American Burn Association annual meeting, new data were presented on Nexobrid's emergency use during the Israel-Hamas war. Nexobrid was used to treat patients with blast injuries and complex burns. One hospital reported treating a trauma or a burn patient every minute for 24 hours, highlighting Nexobrid's vital role in mass casualty and emergency situations. Governments around the world took note of NexoBridge impact. In particular, the U.S. government has expressed interest in establishing a domestic backup manufacturing site. In response, we have initiated planning and site selection for a future U.S.-based facility, a project supported by BARDA. We are also seeing increased interest in stockpiling NexoBread as part of a global emergency preparedness effort, and we believe some of these discussions will translate into concrete opportunities once our manufacturing capacity expands. And now, I would like to turn the call over to Hani to review our financial performance in more detail. Hani?