MediWound Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the MediWound fourth quarter 2020 conference call. I would now like to turn the call over to your speaker, Mr. Jeremy Feifer. Thank you. Please go ahead, sir.

Thank you, Natalia, and good morning, everyone. Earlier today, MediWound issued a press release announcing financial results and provided a business update for the fourth quarter and year-end 2020. 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 Gor-Levi, 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 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 and as well as the 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-looking statements. This conference 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 MediWound. Sharon? Thank you, Jeremy.

Thank you, Jeremy. Good morning to our listeners and in the U.S. listeners and good afternoon to our listeners in Israel. Welcome to Mediwound's fourth quarter and full year 2020 conference call to discuss our financial results and business highlights. We are very proud of our results in 2020, especially given the challenges of COVID-19 pandemic. Despite those significant challenges, our team have presented the highest commitment and executed across the board, clinically, operationally, and financially. We are very pleased with the fourth quarter financial results as we continued generating strong product revenue growth compared with the prior year. We have delivered on a BLA filing for NexoBREED. We advanced our Phase 2 adaptive design study of SKRX and we initiated a new clinical development program of our product candidate, 005, to treat non-melanoma skin cancer. Our fourth quarter results demonstrate the significant progress we've made in 2020 on several key metrics that give us confidence regarding our long-term growth profile and the potential for significant growth acceleration as we move into 2021, and we look forward to achieving multiple significant catalysts in 2021. Let me start with a quick review of Nexovrid before providing more details on SKRx development program and our new and exciting non-melanoma skin cancer clinical development program. We are pleased to see product revenue growing and the global expansion of NexoBridge to new territories. From an operational standpoint, we continue to generate strong revenue growth with NexoBridge, aided by our NexoBridge strategic partnership with BARDA and our continued expansion globally through distribution agreements with partners who are leaders in each of their countries. Following the BLA submission for Nexobrid, we look forward to potentially adding one more major country offering Nexobrid this year, the U.S. We continue to work together with BARDA, VeriCell, and the FDA during the regulatory review process as we prepare for our PADUFA goal date of June 29th as our U.S. commercial partner for Nexobrid, VeriCell, actively preparing for commercial launch. As a reminder, we achieved several additional accomplishments with NexoBrit this year. The DETECT study, including its long-term follow-up, was completed, and the 24-month patient follow-up safety data was comparable across all arms. We completed the patient enrollment stage in the NexoBrit pediatric study, expecting top-line data in the second half of 2021, and continue to enroll burn patients in the next expanded access program, enabling U.S. burn specialists and their teams to generate hands-on experience with NexoBridge. Moving to our S-CAREX development programs, we continue to actively recruit patients for our U.S. Phase II adaptive design study for the treatment of venous leg ulcers. Recently, we have adjusted enrollment target of the study to 120 patients down from the 174 originally planned. The sample size adjustment was supported by in vivo trial results, which I will elaborate on shortly. as well as statistical powering assessment of our prior Phase II study with first-generation SCRx. The current design enables us to accelerate study completion while keeping the option to increase the sample size, if required, based on the interim assessment. We expect to complete patient enrollment by year-end 2021 and reiterate our expectation for the interim assessment around mid-year 2021. We successfully completed a preclinical study designed to evaluate the debridement efficacy of SKRx in a post- and hard-to-heal wound model and compare its efficacy with an FDA-approved and commercially available collagenous enzymatic debridement agent. conducted in collaboration with the U.S. Research Center, concluded that Escarex treatment was more effective than the commercially available collagenase agent in removing Escares in this model. And the results from this study are expected to be published in a peer-reviewed journal in the first half of 2021. We continue to explore Escarex pharmacological effects and its potential clinical benefits associated with chronic wound management. We submitted a protocol to the FDA and are preparing to initiate a pharmacology study in the first half of 2021. The study is an open-label, single-arm study assessing the pharmacological effect of SCRx in up to 15 patients with both VLUs, venous leg ulcers, and DFUs, diabetic foot ulcers. This study will teach us what is happening in the wound bed during and after debridement with SKRx. In particular, it will enable to assess the effect on reduction in biofilm burden, reduction in inflammation, and healing progression. We expect data from this study in the second half of 2021. To provide a more in-depth review of our SCRx Clinical Development Program, we plan to host an analyst day in the coming weeks. This event will feature multiple speakers who will discuss the current wound care treatment landscape in the U.S., the particulars of our ongoing clinical studies, the in vivo comparator study, and the biofilm opportunity. Please stay tuned for more details soon, and we look forward to your participation. We are also exploring pipeline opportunities and are excited with the initiation of our new clinical development program for the treatment of non-melanoma skin cancer with our product candidate under development, 005. The initiation of this new program represents an important step in our strategic evolution to leverage our innovative enzymatic platform technology to pioneer solutions for unmet medical needs. 005 is a biological product candidate for topical self-administration, which is based on the same active ingredients as Nexobrid and Escarex products, a concentrate of proteolytic enzymes and rich in bromelain. The company's decision to investigate 005 and move it into human trials for non-melanoma skin cancers is based on positive preclinical studies combined with existing scientific evidence demonstrated the bromelain anti-carcinogenic activity, which reflected by inhibition of cancer cell growth via apoptotic cascade and reduction of tumor formation and volume. The preclinical studies were performed in parallel with successful clinical case studies that demonstrated the product candidate's safety and its pharmacology effect, suggesting that 005 might have a role in treatment of low-risk non-melanoma skin malignancies. Non-melanoma skin cancers, including basal cell carcinoma, BCC, are by far the most common of all types of cancers and represent a significant potential market opportunity. According to the American Cancer Society, BCC is the most diagnosed skin cancer in the United States, with approximately 4.3 million diagnosed cases every year, increasing 5% to 8% a year as a result of increased sun exposure greater life expectancy, and better skin cancer detection. There is a need for more effective, safer topical treatment options in low-risk BCC, and we believe that 005 has the potential to be an effective, non-invasive treatment for BCC without the side effects associated with the current topical therapies and their longer treatment duration. We plan to initiate a Phase 1-2 open-label randomized clinical study of 005 in BCC designed to evaluate safety and tolerability using different schedules of administrations, as well as to provide us with a preliminary evaluation of its efficacy as measured by the percentage of target lesion with complete histological clearance. The study will enroll up to 32 patients with histological confirmed superficial or nodular BCC and will be conducted at three leading clinical centers in the U.S. In parallel, an investigator-initiated Phase II trial will be conducted at the Soroka Medical Center in Israel, designed to evaluate the safety and efficacy of 005 in removing non-melanoma skin cancer and precancerous lesions in up to 50 patients, including actinic keratosis, basal cell carcinoma, and squamous cell carcinoma. We expect that data from both studies will be generated by ERA in 2021. In summary, we believe that 0.0.5 represents a de-risk opportunity, leveraging our lead compound used in SCRX and NexoBREED, targeting a sizable market with a clear unmet need and requires relatively low development costs. We are pleased with our achievements so far and looking forward to a pivotal year in 2021. Now, I would like to turn the call over to Boaz for a summary of our financials.