MediWound Ltd.

Good day, and welcome to the MediWound third quarter 2021 earnings conference call. Today's conference is being recorded. At this time, I would like to turn the call over to Monique Cossie of LifeSci Advisors. Please go ahead.

Thank you, Sarah, and good morning, everyone. Earlier today, MediWound issued a press release announcing financial results for the third quarter 2021. You may access that release on the company's website under the Investors tab. With us today is Sharon Malka, Chief Executive Officer of Mediwoon, and Boaz Gurlevi, Chief Financial Officer. Following management's 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 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. Although the company believes that 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 forecast due to the impact of many factors beyond the control of medical. 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 the risk factors set forth in MEDAWN'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. The conference call is property of MEDAWN, and any recording or rebroadcast is expressly prohibited without the written consent of MEDAWN. Now I'd like to turn the call over to Sharon Malka, Chief Executive Officer of MEDAWN. Sharon.

Thank you, Monique. Good morning to our US listeners and good afternoon to our listeners in Israel. Welcome to our third quarter 2021 conference call to discuss our financial results and provide you with our business highlights. We have been very active this quarter and the subsequent weeks, making progress across our portfolio. We are nearing some very important and value-increasing events in both of our lead programs. We gained regulatory clarity on the path forward for resubmission of the NexoBREAD-BLA following a productive Type A meeting with the FDA, and we continue to advance significantly the SKRx Clinical Development Program towards data readout. Let me begin first with a review of our SKRx program followed by an update on our next OBRIT program. Starting with the SKRx, we made a significant progress in the clinical development plan. Our SKRx team has been very busy as we near completion of enrollment in our ongoing phase two adaptive design trial for the treatment of venous leg ulcers. We anticipate completing enrollment before the end of this year, and currently, expect to report top-line data from this study in the first quarter of 2022, earlier than originally planned. As a reminder, this study is a multicenter, prospective, randomized placebo-controlled study in 120 patients designed to assess safety and efficacy of SKRX in debridement of VLUs. The primary endpoint in this trial is incidence of complete debridement compared with gel vehicles. In conjunction with our Phase II adaptive design trial, our team has also been focused on executing on our Phase II pharmacology study, and we are on track for generating initial data by the end of this year. As a reminder, the pharmacology trial is an open-label, single-arm study in up to 15 patients designed to assess the pharmacological effects of S-Correct in both diabetic foot ulcers and venous leg ulcers. We aim to gain a better understanding of what is happening in the wound bed both during and after debridement with S-Correct and to assess number of clinical effects impacting wound healing. Lastly on S-Correct, we are very pleased to see our in vivo head-to-head comparator study of Escarex published in the Journal of Wound Care, a well-esteemed peer-reviewed paper. The study showed Escarex to be more effective than the commercially available collagenous product in removing the eschar in this porcine eschar model. We are very enthusiastic with this program and believe Escarex has the potential to become a game changer in the chronic wound-deprived market. We look forward to having data from both trials soon, which we believe to add much value to our growing portfolio. Moving to NexoBREED, we recently had a productive type A with the FDA, where there is agreement on the path forward to address the questions and information requests by the FDA. We continue to partner with Ferricel and BARDA, and we're currently targeting a PLA resubmission in mid-2022. We anticipate a six-month review period with a potential approval by year-end 2022. In tandem, we continue to enroll new patients at leading U.S. parent centers to the next expanded access program, which will run through approval. We remain enthusiastic about the prospects and long-term potential for NexoBREED and look forward to potentially bringing this innovative product to the U.S. market as expeditiously as possible. We are thrilled to announce earlier this quarter positive top-line results from our Phase 3 study of NexoBREED in children with severe thermal burns, which met all its primary endpoints with high degree of statistical significance, reinforcing the strong clinical safety and efficacy profile of the product. Following those results, we are planning to submit the data for label expansion in Europe and other international markets during 2022, and believe it would further enhance growth and global expansion of NexoBREED. On the commercial front, we continue to gain commercial traction in Europe and globally. BARDA's procurement for the emergency stockpile continues to drive product revenue growth, and we are expecting to recognize the remaining revenue related to the BARDA procurement by end of the first quarter 2022. In addition, we continue to execute on our global expansion strategy with sustained revenue growth, we see more and more burn centers around Europe embracing NexoBread as their standard of care. Globally, we recently received marketing approvals in Ukraine, Taiwan, and United Arab Emirates and anticipate more to come in lucrative markets such as Japan, India, and others during 2022. Lastly, we recently initiated a U.S. Phase 1-2 study of 005 products for the treatment of low-risk passive cell carcinoma, and a Phase II investigator-initiated trial in non-melanoma skin cancers is running in parallel, with data from both expected in the first half of 2022. Now, I would like to turn the call over to Boaz for a summary of our financials.