MediWound Ltd.

Good day and welcome to the Meadowounds third quarter 2022 earnings call. Today's conference call is being recorded, and at this time, I would like to turn the conference over to Monique Cossey of LifeSci Advisors. Please go ahead, ma'am.

Thank you, operator, and welcome, everyone. Earlier today, Meadowounds issued a press release announcing financial results for the third quarter ended September 30th, 2022. You may access that release on the company's website under the Investors tab. With us today are Ofer Gonin, Chief Executive Officer of Meadowoon, and Boaz Gurlevi, Chief Financial Officer. 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 Meadowoon'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 MediWound. 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 MediWound's annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward booking statements. The conference call is the property of Meadowood and any recording or rebroadcast is expressly prohibited without the written consent of Meadowood. Now I would like to turn the call over to Ofer Gonan, Chief Executive Officer of Meadowood. Ofer?

Thank you, Monique. Good morning, everyone. Welcome to our third quarter 2022 conference call to discuss our financial and operational highlights. This quarter, we continue to be on track with a series of positive announcements across all our programs. We are approaching several significant inflection points for the company. We believe that once NexoBridge is approved, it will generate meaningful revenues in 2023 and significant growth going forward. Following the launch of NexoBreed, we will focus on a billion-dollar market opportunity presented to us with Estarex, where we plan to initiate a phase three study next year. We have all the essential elements aligned for success, a mature pipeline, favorable data, large addressable markets, an experienced operational team, T1 partners, and a strong balance sheet. Before I discuss the progress we made this quarter, I would like to address the capital raise we completed in October, where we have added an additional $30 million to our balance sheet through a combined registered direct and a pipe offering. This significant addition of funds will support our activities through 2025. It was important for us to complete this raise now ahead of our expected positive news to better position Mediwound for success. We saw participation of our current shareholders, and as an additional benefit, we were able to bring in new validating investors for the company. Also, we were pleased with the vote of confidence from both our management team and board members participated in the offering, demonstrating commitment and firm support of our strategy. Now, with the funding, we will be able to accelerate our clinical progress for Estarex, scale up manufacturing to address the increasing demand for NexoBridge, and support our global operations. We are in a strong fundamental position for the future. both the near and long term. In addition to securing our financing, we have established a strategic advisory board comprised of highly esteemed industry leaders, Dr. John Lantis, Samuel Moed, and Eric Shemtoff. They will contribute their experience and insight to our strategic and operational activities by sharing their medical expertise in all aspects of wound care, providing the knowledge of life science innovation, and supporting us with scale-up our manufacturing facilities and optimize our manufacturing processes. As a CEO, I believe engaging with such talents is essential in advancing MediWound into becoming a world-class biopharmaceutical company. Moving to our clinical development program, let me start with an update on Estorex, where we have demonstrated the tremendous unmet medical needs and our belief in the significant commercial opportunity. We are now more certain than ever of its potential to become a blockbuster. Our phase two results from both clinical studies were robust. Estorex was proven to be safe, well tolerated, effective, and superior to the non-surgical standard of care across all key parameters, including the incidence of complete debridement, the number of applications that are required, the time to achieve complete debridement, etc. We also saw reduction of biofilm and bacterial burden, which further demonstrated escarex's superiority over the other debridement modalities. These results were highlighted in two poster presentations at the Symposium on Advanced Wound Care in Las Vegas. We were honored when one of the poster presentations was selected out of the 290 abstracts to be the one featured as an oral presentation. The data were very well received. Our next step in the coming few weeks is to meet with the FDA discuss the Phase III study design. We will provide an update once we gain clarity of the regulatory path forward. In the meantime, we are on track and prepared to initiate our planned pivotal Phase III study in the first half of 2023. We believe that our S-Correct clinical development program is the risk, not only due to the robust data we've generated to date, but also due to the fact that S-Corect has the same API as NexoBread. And we have seen NexoBread used as a commercial product to successfully treat over 11,000 patients worldwide. We continue to generate interest from strategic players. A topical debridement agent with a competitive quality demonstrated by S-Corect in the Phase II studies is something most players in the wound care market are following very closely. We are evaluating all of our options, from collaborating with a strategic partner to developing S-Corex on our own. We are pleased to be very well positioned with the flexibility to create significant shareholder value. We believe we have a winner here. Turning to NexoBridge. As we announced in our last call, the NexoBridge BLA resubmission was accepted for review by the FDA and given a PDUFA date of January 1, 2023. The FDA's review of the BLA is progressing, and inspection of our manufacturing facilities in Taiwan and in Israel are underway. Our partner, VeriCell, continues to actively plan for a potential NexoBridge launch in the first half of 2023. Our Expanded Access Program, NEC, continues to enroll patients and help physicians gain important first-hand experience with NexoBridge. To date, 183 burn patients have been treated with NexoBridge at 24 of the leading burn centers in the United States. These sites have been very supportive of Nexobrid. The patient and physician experiences confirm our belief that Nexobrid will become an important part of the standards of care practice in the United States. Additionally, I am pleased to report that our collaboration with the United States Department of Defense for the development of Nexobrid as a non-surgical solution for the treatment of burns in the field remains on track. In Europe, cells of Nexobrid steadily grow. We see that Nexobrid is embraced as the standard of care in more and more countries. Last quarter, we sent a pediatric label extension request to the European Medicines Agency and we anticipate a decision in first quarter of 2023. Pediatric patients represent about 25 to 30% of the total burn population. They often face painful surgery, which can be very traumatic to the young patients and their families. An approval will allow pediatric patients to have safe, fast, and effective debridement option without having to undergo a painful surgery. The growing interest in burn mass casualty incidents preparedness in Europe is another opportunity for Nextabridge. This is fueled in part by the Ukrainian-Russian conflict and by mass casualty events that have occurred just recently. While we are unable to quantify the magnitude of this opportunity, we believe that the preparedness strategy that Varda endorsed in the United States will be embraced in Europe as well. Lastly, we were pleased by the warm reception we received at the 19th European Burn Association Congress in Italy. NEXOBRID was highlighted in 45 posters and presentations. Leading burn specialists and thought leaders from around the world shared their positive experiences patient outcomes using Nexobrid in a wide range of settings. Internationally, we anticipate additional approval in large, meaningful markets such as Japan and India by the end of this year. To date, Nexobrid is approved in 41 countries and we look forward to the expansion. Turning to MW005, we continue to move forward in the development of the topical treatment for the patients with basal cell carcinoma, or BCC. We saw positive initial results from our U.S. Phase I-II study. MW005 was shown to be safe and well-tolerated with the majority of patients who completed the study achieving clinical and histological clearance of the target lesions. We anticipate announcing the study results by the end of this year. In conclusion, we are very well positioned to continue to excel across the board. We anticipate the potential approval and commercial launch of NexoBridge in the United States. This will also enable us to generate meaningful revenues in the near term. We are eager to launch our Phase III people that program in X-Correct, and we continue to develop a compelling pipeline of follow-on therapies such as MW005. We have all the resources to do that. I am very optimistic about MediWood's future and look forward to updating you on our progress. Let me now turn the call over to Boaz for a brief review of our financials. Boaz?