MediWound Ltd.

Good day, and welcome to the MediWN First Quarter 2022 Financial Results and Presentation of the S-Corrects Phase 2 Clinical Trial Results Conference Call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key followed by 1 on your touchtone phone. If anyone has difficulty hearing the conference, please press star 0 for operator assistance, At this time, I'd like to turn the conference over to Monique Cossie of LifeSci Advisors. Please go ahead.

Thank you, Operator, and welcome, everyone. Earlier today, Meadowoon issued a press release announcing its first quarter 2022 financial results and provided a corporate update. We will be reviewing those results with the management team, in addition to hearing from two KOLs on the results of the SGREX US Phase 2 trial. which were announced in a press release issued on May 12th, 2022. You may access both releases on the company's website under the Investors tab. With us today from management are Sharon Malka, Chief Executive Officer of Mediwoon, Ofer Gonan, Board Member, and Boaz Gurlevi, Chief Financial Officer. Also joining us are Professor Leo Rosenberg, Chief Medical Officer, and Dr. Sai Dove from Advanced Wound and Ankle Center, Las Vegas, and an investigator in the ASCREx Phase II studies. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MediWound'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 forecast due to the impact of many factors beyond the control of Meadowood. 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 METAWOON'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. At this time, I would like to turn the call over to Sharon Maltha, Chief Executive Officer of METAWOON. Sharon?

Thank you, Monique. Good morning to our listeners in the U.S., and good afternoon to those joining us from Israel. Welcome to our first quarter 2022 conference call to discuss our financial and recent operational highlights. We are very pleased to have two esteemed key opinion leaders with us on the call today, Professor Leo Rosenberg, Chief Medical Officer of MediWound, and Dr. Sai Dav, a principal investigator in both our SCRx Phase II studies and the pharmacology study from the Advanced Wound and Ankle Center in Las Vegas. They will share their insights on our SCRx trial and data and also provide some perspective on the overall wound care practices. After our data discussion, we will hear a quick review of the financials from BOAS before opening the call for a Q&A. First, let me provide a quick review of our quarter and recent updates before taking a deeper dive with our KOL into the clinical data for Escarex. Starting with Escarex, we were excited to report positive data from the U.S. Phase II clinical study of Escarex for the debridement of venous leg ulcers. The study met its primary and its key secondary endpoints with statistically significant results compared to the control arms. The study demonstrated significant improvement over the current standard of care, and no observed deleterious effects on wound closure and no safety issues were observed. We highlighted some of these results at the SAWC Spring 2022 Symposium in April and received a very warm welcome and high interest by the top wound care specialists from around the globe. The interest was very encouraging, and we were very pleased to have received recognition for our poster, which was selected as one of the top 10 posters out of the 235 posters at the conference. In our NexoBread program, we continue to partner with Barda and Ferricel for the approval of NexoBread and look forward to bringing this innovative product to the U.S. market. We remain on track for a mid-year resubmission of the NexoBread BLA, and we anticipate a six-month review process which would position NexoBread for a potential approval by year-end and a commercial launch in the U.S. in the first half of 2023. To that end, BARDA expanded its contract, providing us with supplemental funding of $9 million to support the NexoBridge BLA resubmission and the ongoing expanded access protocol, which will run through approval. Lastly, on NexoBridge, we are proud to have started the project with the U.S. Department of Defense for the development of NexoBridge for the U.S. Army as a non-surgical solution for field care burn treatment. This research project, if successful, could open the gate for armies all over the world, as well as simplify our supply chain costs and administration. Let me now provide a quick review of SKRx Phase II study design and the key results before handling the call to our STEAM KOL. The study was a multicenter prospective randomized placebo-controlled adaptive design study evaluating the safety and efficacy of S-CAREX in debridement of PLUs compared to gel vehicle as a placebo control and compared to the non-surgical standard of care of either enzymatic or autolytic debridement. The study enrolled 120 patients with 119 treated at approximately 20 clinical sites, primarily in the United States. Study participants were treated by either SCRX 46 patients, gel vehicle 43 patients, or non-surgical standard of care and other 30 patients with a three-month follow-up. The single primary endpoint was incidence of complete debridement clinically assessed within up to eight medications during an assessment period of 14 days compared to the gel vehicle placebo control as agreed with the FDA. Secondary and exploratory endpoints assess time to achieve complete debridement, reduction of pain, reduction of wound area, granulation tissue, and quality of life, enabling evaluation of clinical benefits compared to both gel vehicles and the standard of care. Incidents and time to achieve wound closure were assessed at safety measurements. Turning now to the study results, the study met its primary endpoints with a high degree of statistically significant, demonstrating that patients treated with escarex had a statistically significant higher incidence of complete debridement compared to the gel vehicles. More specifically, 63% of the patients treated with Escarex, 93 patients out of 46, achieved complete debridement by the eighth treatment. And this compares with only 30% of the patients treated with hydrogel vehicle, which is about 13 patients out of 43, with a p-value of 0.004. Escarex efficacy superiority remains statistically significant compared to the gel vehicle, also after adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size, wound age, and region. The study also met its key secondary and exploratory endpoints that provide further insights on additional efficacy parameters and can establish clinical benefits. starting with head-to-head comparison with the non-surgical standard of care, including enzymatic debridement or autolytic debridement. Sixty-three of the patients treated with Escarex achieved complete debridement compared to only 13% of patients treated with standard of care, four patients out of 30 patients, within the 14-day assessment period. And the time to achieve complete debridement was significantly shorter. The estimated median time to complete debridement was nine days for patients treated with SKRx compared to 59 days for patients treated with a non-surgical standard of care with a p-value of 0.01. Moreover, on average, complete debridement was achieved after less than four applications with SKRx compared to almost certain applications with the non-surgical standard of care. This significant improvement over the current standard of care is important when you consider that the non-sharp debridement agents, enzymatic or others, currently available on the U.S. market require daily application for several weeks to achieve complete debridement, yet still generates hundreds of millions of dollars every year. Patients treated with escarex demonstrated significantly higher incidence of at least 75% granulation tissue at the end of the treatment period compared to the gel vehicle, with a p-value lower than 0.001, which is required for wound healing. And finally, a favorable trend were observed in wound area reduction and reduction of pain compared to gel vehicles. The above efficacy results achieved our key goals in this study. One, to demonstrate that escharic efficacy in debridement chronic wounds. Two, to establish a clear improvement over the current standard of care. And three, to give us a clear guidance for future pivotal studies in the indication of our interest. In addition, the study showed that SKRx was safe and well tolerated, and the overall safety was comparable between all arms. Importantly, there were no observed deleterious effects on wound closure and no material differences in reported adverse events. Actually, the estimated time to complete wound closure was 64 days for patients treated with Escarec, compared to 78 days for patients treated with standard of care. With that, we achieved additional goal for this phase to study, which was to assess the Escarec safety and tolerability, and show that it's well tolerated treatment for debridement of chronic wounds. Let me now turn the call over to Professor Rosenberg our chief medical officer, to provide us with some color regarding the unmet need, the role of debridement in wound management, the robust clinical evidence generated to date, and how a product like Escarex would fit the current treatment paradigm. Professor Rosenberg, please.