MediWound Ltd.

Good day and welcome to MediWound's second quarter 2024 earnings call. Today's conference is being recorded. If you require operator assistance, please signal for an operator by pressing the star key then zero on your telephone keypad. At this time, I would like to turn the conference over to Gaia Shamus of LifeSci Advisors. Please go ahead.

Thank you Chris and welcome everyone. Today, before the market opened, Medibund issued a press release announcing financial results for the second quarter ended June 30, 2024. You may access that release on the company's website under the Investors tab. With us today are Ofer Gunen, Chief Executive Officer of Medibund, Hany Luxemburg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our 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 anyone'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 MediMund. 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 filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statement. 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 Ofer Gonen, Chief Executive Officer of Mandibond. Ofer?

Thank you, Gaia, and good morning, everyone. We appreciate you joining us today as we are excited to share the results of another strong quarter. The second quarter has been pivotal for our company as we continue to execute our strategic plan to become a global leader in tissue repair. At the beginning of the year, we set three key goals. First, to complete the construction of our new manufacturing facility. Second, to accelerate the revenue growth of Nexobrid. And third, to initiate the Phase III clinical trial of Escarex. I am pleased to report that we have successfully completed the first goal and we are well on track to achieving the remaining two. Moreover, we awarded €16.25 million in funding for the expansion of Escarex Indication to include diabetic foot alters, significantly increasing the product's total addressable market. We also raised $25 million in financing, led by industry leader Molneke, reflecting strong confidence in our technology and significantly enhancing our financial position. Let me begin with an update on NexoBRED, our drug for eschar removal for severe burns. As mentioned, we have completed the construction of our new state-of-the-art GMP-compliant manufacturing facility for NexoBRED. The commissioning process will begin soon and we aim to achieve full operational capacity in 2025. The new facility will allow us to support the growing global demand for NexoBRED by increasing our manufacturing capacity six-fold. In the United States, the launch of NexoBrit by VeriCell continued to build strong momentum. Approximately 70 burn centers have completed submission to their P&T committees, with over 40 centers already obtaining approval, and nearly all of them placing initial product orders. VeriCell reported a notable increase in hospital orders and the number of patients treated, driving a revenue growth of 76% over the prior quarter. Additionally, we anticipate FDA approval of the pediatric indication for Nexobrid very soon, which would provide a crucial treatment option for pediatric patients with severe thermal burns. We also had positive results from the United States NexoBRED Expanded Access Protocol, the NEXT program. Initiated in 2019, NEXT ensured the continuous availability of NexoBRED in burn centers prior to its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this lifesaving treatment, and facilitated the accumulation of real-world safety clinical data for Nexoprid. The study was conducted at 29 burn centers across the United States and enrolled 239 patients, including 215 adults and 24 children with severe thermal burns covering up to 30% of total body surface area. Defining from the next, are consistent with the data from the DETECT and the KIDS Phase III trials, reinforcing the critical role that NexoBREAD should play in standard burn care protocols. NexoBREAD was reaffirmed as a safe and effective eschar removal enzymatic agent that successfully reduces the need for surgical procedures in burn patients. Regarding the development of a room temperature-stable formulation of Nexobrid, our partnership with the United States government remained very strong. During a recent type meeting, the FDA provided comprehensive guidance on our CMC plan, nonclinical development plan, and regulatory strategy. We also received initial feedback on our clinical trial design, indicating that we will be able to initiate a clinical trial in 2026. The DoD has awarded us an additional $1.5 million to support our ongoing research and development activities. Turning now to escorex, our innovative therapy for the riding chronic wounds, there have been several exciting developments. We received 16.25 million euros in funding from the European Commission through a prestigious and highly competitive program. This funding will facilitate the expansion of SCRX's indications to include diabetic foot alters, or DFUs, a substantial and underserved market. Notably, this will expedite our associated revenue projections by four years. Preparations for the DFU Phase 2-3 study are currently underway. Proper treatment of diabetic foot ulcers is critical to preventing serious complications, including amputations, infections, and even death. Let's look at the numbers. Among the 38 million diabetic patients in the United States, approximately 30% will develop DFUs in their lifetime. 70% of these patients, and we are speaking about 1.6 million patients every year, will require debridement, either with a painful surgical procedure or with an ineffective alternative treatment. Our program has the potential to have a significant impact on the treatment of diabetic foot ulcers, transforming the current standard of care to a very simple, quick, and safe solution, a dramatic benefit to the millions of patients. We are also finalizing the preparations for our Phase III study for treating venous leg ulcers, VLUs, following the success of our Phase II trials. The results of one of these Phase II trials were recently published at the Lancet eClinical Medicine Journal, demonstrating escorex's superiority over the non-surgical standard of care in debridement and in the promotion of healthy granulation tissue. The upcoming Phase III study will replicate the successful design of our Phase II trials and will be structured as a multicenter, prospective, randomized, and placebo-controlled global trial. We aim to enroll 216 patients across over 40 sites. An interim assessment will be conducted after 67% of the participants have completed the trial and providing early insights into the efficacy of S-Corex. This study is scheduled to start in the second half of 2024, as planned. Our ability to consistently execute on multi-year plans, as reflected in the significant progress of our NexoBreed and Escorex programs, has attracted strategic interest from prominent industry players. Just recently, we raised $25 million in private investment led by Malnicki Healthcare. a global leader in the wound care solutions. This investment demonstrates confidence in our technology and significantly strengthen our financial position. In addition, we have signed a strategic collaboration agreement with them. The agreement provides us with access to Molniki's common insights, its critical clinical and regulatory expertise, and educational resources. This also includes Molniki's participation in certain potential strategic partnership discussion and M&A processes. This collaboration aims to enhance our strategic plans and create substantial long-term value for our stakeholders. Now, I will hand it over to Hani to briefly review our financials.