Business
MediWound Reports First Quarter 2023 Financial Results and Provides a Company Update
On track to initiate EscharEx® Phase III study in fourth quarter 2023NexoBrid® U.S. launch expected in early third quarter 2023Cash of over $57 million;
About this update from Mediwound Ltd.
[{"type":"text","content":"On track to initiate EscharEx® Phase III study in fourth quarter 2023NexoBrid® U.S. launch expected in early third quarter 2023Cash of over $57 million; Operating cash runway through profitability Conference call begins today at 8:30 a.m. Eastern Time YAVNE, Israel, May 30, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update. \"This quarter has been extremely productive as our dedicated team has worked diligently to advance the key components of our strategic plan. The outcomes of our focused efforts are evident, as we are on track to initiate the Phase III study for our flagship product, EscharEx, in the fourth quarter of this year. This represents a significant commercial opportunity and addresses a major unmet need. Furthermore, we are excited to partner with Vericel for the upcoming U.S. launch of NexoBrid. Simultaneously we are making rapid progress in our manufacturing scale-up plan to meet the surging global demand. Importantly, MediWound is now in a strong financial position, with over $57 million in cash. This provides the company with ample resources to effectively execute its corporate initiatives and drive continuous innovation,\" stated Ofer Gonen, Chief Executive Officer of MediWound. First Quarter 2023 Highlights and Recent Developments: The Company’s global Phase III clinical study for EscharEx is expected to begin in the fourth quarter of 2023. The pivotal trial protocol is aligned with feedback from the U.S. Food and Drug Administration (FDA); protocol feedback from the European Medicines Agency (EMA) anticipated in mid-year 2023. This multicenter, prospective, randomized, placebo-controlled trial aims to evaluate the safety and efficacy of EscharEx in patients with venous leg ulcers (VLUs). Approximately 244 patients will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications. Patients will be followed for up to 22 weeks after treatment, during which all patients will be treated with standard of care. The co-primary endpoints a...