MediWound Ltd.

Good day and thank you for standing by and welcome to the Quarter 1 MediWound 2021 conference call. At this time, all participants are in listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star and then the number 1 on your telephone keypad. 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 turn the conference over to your speaker today, Mr. Jeremy Pfeffer. Please go ahead, sir.

Thank you, and good morning, everyone. Earlier today, MediWound issued a press release announcing financial results and provided a business update for the first 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 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 Meduun'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 MediWound. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future results, 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 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 the property of MediWound, and any recording or broadcast 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. Good morning to our U.S. listeners and good afternoon to our listeners in Israel. Welcome to MediWound's first quarter 2021 conference call to discuss our financial results and business updates and highlights. This quarter, we continue to generate product revenue growth compared with prior year, driven by the procurement of NexoBread by BARDA for emergency response preparedness and out-of-U.S. sales. as we continue to execute on our global expansion strategy of expanding the use of NexoBREAD in additional international markets. In addition, we have gained progress across each of our ongoing clinical programs, highlighted by the enrollment of the first patient in our Phase II pharmacology study of escarex and the launch of our new program in non-melanoma skin cancer, while we continue to advance our U.S. Phase II Adaptive Design Study of ASCAREX for the treatment of venous leg ulcers. Let me now provide you with a more color on the progress we made and review of the first quarter highlights. Starting with Nexobrid, we continue to enroll new patients to the next expanded access program at leading U.S. burn centers, with 82 burn victims who were already treated with Nexobrid to date. The expanded access study runs through approval, and there is plenty of opportunity to continue to enroll patients across over 20 sites, which will continue to increase burn surgeons' experience with Nexobrid. The pediatric study is fully enrolled, and we expect to report top-line results from this study in the third quarter of 2021. On the commercial front, BARDA procurement for emergency stockpile continue to drive product revenue growth, and we are expecting to recognize the remaining revenue related to BARDA procurement of NexoBREED in 2021. We are satisfied with NexoBREED global expansion into new international markets, supporting our top line signing additional distribution agreements in Europe and Asia, and receiving marketing approvals for NexoBREED in Taiwan and Chile. Turning to the BLA, in September 2020, the FDA accepted for review our BLA for NexoBREED for severe burns and assigned a PADUFA goal date of June 29, 2021. However, as is apparent from recent FDA actions, across the industry, travel restrictions related to COVID-19 pandemic are impacting the FDA ability to complete manufacturing facility inspections and review processes have been affected. Recently, the FDA has informed us that due to these travel restrictions, it may be unable to conduct the required inspections of our manufacturing facilities in Israel and Taiwan by the PADUFA date. and that it is unlikely that the additional CMC information provided in support of our BLA will be reviewed during the current review cycle. The PDUFA goal date remains June 29, 2021, and FDA review is ongoing as we continue to work closely with the agency. At this time, we expect the timing of potential approval and the commercial launch of NexoBREED to be impacted. We are committed to bringing NexoBridge to the U.S. market as our North American commercial partner, VeriCell, continues to make significant progress with respect to its commercial and medical affairs pre-launch activity. Given its robust clinical data package, we believe that NexoBridge remains well-positioned to replace surgical excision as the standard of care for eschar removal in patients with severe burns and we look forward, upon approval, to bringing NexoBREAD to the U.S. market. Moving to our product candidate, Escarex, where our development program is well underway. We continue to actively recruit patients for our U.S. Phase II adaptive design study for the treatment of venous leg ulcers. We are on track to reach the target of 80 patients required for the interim assessment and reiterate our expectation for an interim assessment around mid-2021 and anticipate completion of patient enrollment by year-end 2021. As part of the S-CAREX development program, we are conducting a Phase II pharmacology study to explore the potential clinical benefits of S-CAREX associated with chronic wound management. The study is an open-label, single-arm study assessing the pharmacological effect of SKRx in up to 15 patients with both VLUs and DFUs. This study will provide us with a better understanding of what is happening in the wound bed during and after debridement with SKRx, and more specifically, it will enable to assess the effect on reduction in biofilm burden, the reduction in inflammation, and initiation of healing process. We enrolled the first patient in this study last month and expect data from this study in the second half of 2021. We were proud to host an Escarex Analyst Day in March, featuring four prominent key opinion leaders who discussed the current US wound debridement practices and how Escarex, upon approval, has the potential to change the current standard of practice and care of chronic wounds. Our three key opinion leaders, Drs. Kistner, Singer, and Snyder, spoke about the need for better therapeutics and improving upon the current standard of care. With a billion-dollar market opportunity in each of the VLU and DFU markets, a clear opportunity in the hospital outpatient settings, and potential for meaningful improving on the current standard of care, we believe SKRx can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals, and payers. Moving now to our product candidate 005, we submitted a protocol to the FDA for a Phase I-II clinical study for the treatment of basal cell carcinoma, and we are advancing the initiation, which is planned for the second quarter 2021. This study is designed to evaluate safety and tolerability using different schedules of administration, as well as to provide a preliminary evaluation of its efficacy as measured by the percentage of target lesion with complete histological clearance. In tandem, an investigator-initiated phase two 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 cancers and precancerous lesions like actinic keratosis, basal cell carcinoma, and squamous cell carcinoma. We expect that data from both studies will be generated by the end of this year, 2021. We believe that 005 has a reasonable path to market with a clear unmet medical need, and the clinical plan we have laid out carries relatively low development costs given its active substance, which is the same like NexoBred and SKRx, and the intended indication. In closing, we anticipate 2021 to have multiple data readouts in SKRx and 005 clinical trials and excited about the next opportunity in the U.S. as we continue to work closely with the FDA. We remain focused on continuing to drive growth and further strengthen our company with a deep pipeline of paratherapeutic solutions for tissue repair and regeneration. Now, I would like to turn the call over to Boaz for a summary of our financials.