MediWound Ltd.

Good day and welcome to Mitty Woon's third quarter 2023 earnings call. If you need assistance during today's conference, please press star then zero to reach a conference specialist. After the prepared remarks, there will be a question and answer session. To ask a question, please press star then one. And to remove yourself from queue, please press star then two. Please note today's conference is being recorded. At this time, I would like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead.

Thank you, Operator, and welcome, everyone. Earlier this morning, MediWound issued a press release announcing financial results for the third quarter ended September 30, 2023. You may access this earnings press release on the company's website under the Investors tab. With us today are Ofer Gonan, Chief Executive Officer of MediWound, Honey Luxembourg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to MediWomb'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. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, Actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecasts due to the impact of many factors beyond the control of MediWood. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to cautionary notes set forth in today's press release, as well as risk factors set forth in MediWood's annual report filed with the SEC, for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. Conference call's property of MediWound and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. Now, I'd like to turn the call over to Ofer Gonin, Chief Executive Officer of MediWound.

Ofer? Good morning, everyone, and thank you, Dan, for the introduction. I'm pleased to welcome you to our third quarter 2023 earnings conference call. Joining me today are Hani Luxemburg, our Chief Financial Officer, and Barry Wolfenson, our Executive Vice President of Strategy and Corporate Development. I want to start by expressing a sincere thank you from the entire Mediwound family for the overwhelming support through emails, calls, messages, that I've received from many of you since October 7th terror attack. This war has significantly impacted the lives of many of our employees and their families. We feel privileged that our product can contribute to helping victims and make a difference. Our team is working around the clock to ensure we meet the needs of our community, customers, patients, and partners. This quarter marks a pivotal period for us with significant achievements that set the stage for consistent future revenue growth. NexaBridge was successfully launched in the United States and Japan. In Europe, we expanded both our presence and the target population. Global demand has risen, fueled in part by world conflict and governmental actions. We have responded with the necessary reallocation of resources to meet this increase and continue with our plans to aggressively expand our manufacturing capabilities. Looking ahead, preparation for the phase three study of Estarex are progressing with an updated protocol shaped by both the FDA and EMA guidance. Anticipated enrollment is set to begin in the second half of 2024. A new collaboration with the industry leader 3M Healthcare further validates S-Corex's anticipated impact on the wound care market. Let's have a more detailed look at Nexobrid. It has been a very busy and productive period. Notably, at the end of the quarter, we announced United States commercial availability through our partner VeriCell. VeriCell's launch of Nexobrid is progressing swiftly. Patients started treatment soon after its commercial release. VeriCell is dedicated to securing market access, obtaining P&T committee approvals, and training staff at burn centers. Given the burn care community's positive response to Nexobrid, VeriCell expects rapid adoption and significant growth of their burn franchise in 2024 and beyond. Further supporting the commercialization efforts in the US and elsewhere, the Journal of Burn Care and Research published results from the DETECT phase three study. The study demonstrated that the treatment with NexoBridge resulted in early complete ESCA removal in more than 90% of treated burn patients and reduced the need for surgical excision compared to gel vehicle and the standard of care. With VeriCell's early success, enthusiastic reception, and strong published data, we feel quite confident about NexoBridge's future in the United States. Similarly, in Japan, another major market, NexoBridge was launched this quarter through our partner, Keken Pharmaceutical. The initial feedback from Keken is positive, and it is working diligently to secure contracts in key hospital systems. In Europe, two recent developments are expected to bolster our sales. The first is that the CHMP recommended NexoBread's label extension to include pediatric indication, expanding NexoBread availability to all age groups. This recommendation was based on a global phase three study evaluating NexoBREAD in hospitalized pediatric patients, as well as additional data from area trials. Pediatric patients with severe thermal burns represents approximately 30% of the total burn population. Therefore, this label extension will significantly increase NexoBREAD's addressable market. Secondly, our recently announced collaboration with Polymedics, a burn care market leader, will further the adoption of NexoBread in Europe by expanding our marketing activities in Germany, Austria, Belgium, the Netherlands, and Luxembourg. This collaboration followed NexoBread's impressive presence at the recent European Burn Association Congress, where NexoBridge was featured in 20 oral and poster presentations. In addition to these three key markets, United States, Japan, and the EU, there has been a noticeable rise in global demand for NexoBridge, driven in part by geopolitical conflicts. In Israel, the entire non-US NexoBridge inventory has been deployed to hospitals and military, to successfully treat these affected by the war. The positive outcomes achieved with Nexobrid in the field have prompted additional interest from various governments, including Ukraine, for stockpiling the product. In the United States, we secured a $6.5 million R&D budget from the Department of Defense to advance the development of a new temperature-stable formulation for Nexobrid. It is planned to be the first line non-surgical solution for field care burn treatment for the United States Army. All of these developments, major markets launches, indication expansion, DOD funding, governmental interest, all of these will accelerate the demand for NexoBREAD worldwide. It is therefore critical that we expand our operational capabilities to address this need. Our primary goal is to ensure that our new GMP-compliant state-of-the-art facility is on schedule for completion by mid-2024, reaching full-scale manufacturing capabilities in 2025. To this end, we are focused on assembling the right team and allocating the necessary resources for that. We are thrilled to welcome Dr. Shmulek Hess as our recently appointed Chief Operating Officer and Chief Commercial Officer. With his extensive experience, we are confident that Dr. Hess will play a pivotal role in ensuring the success of our upgraded production and help us refine our commercial strategy. His expertise will undoubtedly contribute to the efforts to meet the escalating market demands effectively. Now I'd like to provide an update on our SCRx program. We have received guidance from both the FDA and EMA on the protocol for the global phase three study, indicating our pathway towards approval. With the strong data from our phase two studies and with the added information we made to the protocol, we are entering the Phase III portion of our clinical development program with great confidence. The Phase III trial is a multicenter, proskeptive, randomized, placebo-controlled study evaluating the safety and efficacy of S-CAREX in patients with venous leg ulcers. The trial will enroll 216 patients equally randomized between S-CAREX and the placebo gel vehicle. The trial will focus on two co-primary endpoints, the incidence of complete debridement at the conclusion of the daily visit period and the incidence of wound closure by the end of the weekly follow-up period. An interim assessment is planned after 67% of the patients have completed the trial. We are currently finalizing the logistic aspect of the trial and anticipate submitting an updated protocol to the FDA in the first quarter of 2024 with patient enrollment to follow by the second half of 2024. At the same time, we are also advancing plans for exploratory studies, including a pharmacokinetic study and a human factor study. These are designed to support the BLA of Escarex and to improve our future commercialization and market access strategies. Much like NexoBridge's notable impact in the burn care market, Escarex is also attracting significant interest in the chronic wound care sector. This is demonstrated by the interest expressed by key market leaders to form research collaborations around our study. To tell you more about these collaborations, I will now turn the call over to Barry. Barry?