MediWound Ltd.

Good day and thank you for standing by. Welcome to the Q2 MediWound 2021 conference call. At this time, all participants are in a listen-only mode. After this speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Jeremy Pfeffer, please go ahead.

Thank you, Dawn, and good morning, everyone. Earlier today, MediWound issued a press release announcing financial results for the second quarter of 2021. You may access that release on the company's website under the Investors tab. With us today are Sharon Malka, Chief Executive Officer of MediWound, and Boaz Gorlevi, 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 Meadowood'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 MediWound's annual report following the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. The conference call is the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. Now, I would like to turn the call over to Sharon Malka, Chief Executive Officer of Network. Sharon? Thank you, Jeremy.

Good morning to our U.S. listeners, and good afternoon to our listeners in Israel. Welcome to our second quarter 2021 conference call to discuss our financial results and business highlights. The second quarter of 2021 and the subsequent weeks have been eventful from a clinical and commercial standpoint, with a positive interim assessment for SCAR-X Phase II study, FDA feedback on NexoBridge VLA, and the robust results of NexoBridge Phase III pediatric study. Commercially, we continued to generate product revenue growth compared with the prior year, driven by the procurement of NexoBridge by BARDA and the revenue's continued growth out of U.S. On the clinical front, we are pleased with the progress we gained across each of our ongoing clinical programs and are encouraged by the positive clinical data for both SCRx and Nexobrit. Let me begin first with a review of our SCRx clinical development program, where we most recently announced the best possible outcome of the interim assessment for its U.S. Phase II adaptive design study. Recall that this study aims to assess the safety and efficacy of escarex for the debridement of venous leak ulcers as compared to gel vehicle and non-surgical standard of care, while the interim assessment served to determine whether a sample size adjustment is required to maintain conditional power for this study. The interim assessment had three potential outcomes. continuation of the trial at its current sample size, an increase in the sample size to power the trial, or a sudden end of the trial due to futility. The interim assessment conducted after about 80 patients, approximately two-thirds of the original enrollment target of 120 patients, completed the debridement treatment. Based on the independence, data monitoring committee's recommendation, the interim assessment yielded two positive takeaways. First, no enrollment sample size changes are necessary to maintain the pre-specified statistical power of 80% or greater for the study's primary endpoint of incidence of complete debridement compared to the gel vehicle. This positive outcome means that the study is appropriately sized at the planned enrollment of 120 patients and can continue without the need to add more patients. As a reminder, we had previously reduced the enrollment target from 174 patients to 120 patients, so we were happy with the independent data monitoring committee's recommendation confirming that change. no safety concerns were identified in the study population, which is another positive result. This successful interim assessment suggests that SCRx is safe and tolerable and provides positive signals that increase our confidence that SCRx may prove to be an effective non-surgical therapy for debridement of chronic wounds. We anticipate completing full enrollment in this study by end of 2021 with data readout anticipated in the first half of 22. Also in our SKX program, we have enrolled our first patients in our phase two pharmacology study and anticipate data from that study later this year. As a reminder, this is a phase two open label single arm study designed to evaluate the clinical performance, safety, and pharmacology effects of escarex in the debridement of lower leg ulcers, i.e., venous leg ulcers and diabetic foot ulcers, in up to 15 patients. The data generated to date for escarex have been very encouraging. We published a peer-reviewed paper summarizing the results of a successful Phase II assessor-blinded study of our first generation Escarex, which achieved its efficacy and safety endpoints. Escarex was well tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other out-wield wounds within a few daily applications. Earlier this year, we completed successfully a comparator in vivo study designed to evaluate the debridement efficacy of Escarex and the commercial collagenous enzymatic debridement agent in a post-in-heart-to-heal model. The study concluded that Escarex treatment was clinically superior to the commercially available collagenous agent in removing Escar in this model. The data from these trials, together with a positive interim assessment, give us confidence in both of our current ongoing Phase II trials of second-generation SKRx, and we look forward to data from both of these trials. With a clear unmet medical need for a non-surgical, rapid and effective debridement agent in the outpatient setting, SKRx has the potential to improve on the current standard of care and have a meaningful impact on chronic wounds management. Turning to NexoBREED, On the commercial front, BARDA's procurement for emergency stockpile continues to drive product revenue growth, and we are expecting to recognize most of the remaining revenues related to BARDA procurement in 2021. In addition, we continue to execute on our global expansion strategy, which sustained revenues growth and expecting additional marketing approvals in lucrative markets during the next 18 months. We continue to enroll new patients to the next expanded access program at leading U.S. burn centers with over 100 burn victims who were already treated with Nexobrid to date. The expanded access program runs through approval. We believe that the continued burn centers training on the use of Nexobrid through the next expanded access protocol will support NexoBridge launch upon approval in the U.S. Turning to the NexoBridge BLA, though we were disappointed with the receipt of the CRL, we believe the FDA comments and concerns are manageable and can be addressed. We will continue to partner with BARDA and VeriCell to leverage their vast experience and track record in regulatory domain, to meet with the FDA as soon as possible, and provide the FDA with a detailed response to the CRL. While it's premature to provide a specific timeline for the BLA resubmission, we are actively preparing for a Type A meeting with the FDA and will provide a further update at the appropriate time. We remain optimistic about the prospects and long-term potential for NexoBREAD and committed to bringing NexoBREAD to the U.S. market as expeditiously as possible. Regarding our pediatric investigational plan, we were thrilled to announce positive top-line results from our Phase III study of NexoBREAD in children with severe thermal burns, which met all of its primary endpoints with high degree of statistical significance, reinforcing the stronger clinical safety and efficacy profile of the product. The data for NexoBit is clear, and we strongly believe it will become an important treatment option for the pediatric burn patients. 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 Nexroid. Turning to our newest clinical development program for non-melanoma skin cancers, we initiated an open-label Phase I-II study of 005 product in basal cell carcinoma designed to evaluate the safety and tolerability of the product using different schedules of administration. This study will provide us with a preliminary evaluation of 005 efficacy, and this could be a very exciting program for us. In tandem, the first patients were enrolled in an investigator-initiated phase two trial conducted at the Soroka Medical Center in Israel, designed to evaluate the safety and efficacy of 005 in removing normal melanoma skin cancers. We expect that data from both studies will be generated by the end of 2021. Lastly, we were pleased to have the case series data of passive cell carcinoma destruction by a concentrate of portalitic enzymes enriching bromelain, which is actually 005, published in a peer-reviewed paper. provide a preliminary proof of concept that 005 may be a safe and effective destructive treatment for basal cell carcinomas, and more importantly, establish the foundation for our non-melanoma skin cancer clinical development. Now, I would like to turn the call over to Boaz for a summary of our financials.