Business
MediWound Reports First Quarter 2022 Financial Results
Positive Results from Its U.S. Phase 2 Trial of EscharEx for Debridement of Chronic Wounds On track for NexoBrid BLA resubmission by mid-year Conference Call
About this update from Mediwound Ltd.
[{"type":"text","content":"Positive Results from Its U.S. Phase 2 Trial of EscharEx for Debridement of Chronic Wounds On track for NexoBrid BLA resubmission by mid-year Conference Call Begins Today at 8:30 am ET YAVNE, Israel, May 17, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced Financial results for the first quarter ended March 31, 2022. First Quarter and Recent Weeks Financial Highlights Total revenues for the first quarter of 2022 were $4.4 million compared to $5.8 million in the first quarter of 2021Raised an additional $10 million of total net proceeds through an equity offeringCash and short-term investments of $16.8 million as of March 31, 2022 Business Highlights and Updates: Positive results from its U.S. Phase 2 clinical study of EscharEx® for the debridement of venous leg ulcers (VLUs): (i) the study met its primary and its key secondary endpoints with statistically significant results compared to control arms; (ii) significant improvement over the current standard-of-care; and (iii) no deleterious effects on wound closure and no observed safety issues.EscharEx clinical data from phase 2 clinical trials was highlighted in poster and oral presentation at the symposium of advance wound care (SAWC) The Biomedical Advanced Research and Development Authority (BARDA) expanded its awarded contract by providing supplemental funding of $9 million to support the NexoBrid BLA resubmission with the FDA and the ongoing expanded access treatment protocol (NEXT)Awarded a U.S. Department of Defense (DoD) research grant for the development of NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army “EscharEx is demonstrating to be a true game changer, and we believe the robust results position it at the forefront of enzymatic debridement solutions for chronic and hard to heal wounds,” said Sharon Malka, Chief Executive Officer of MediWound. “We believe we have a clear path forward to advance EscharEx clinical program into pivotal Phase 3 clinical trials and current next step is to meet with the U.S. FDA in the second half of this year to discuss the clinical program. Additionally, we are looking forward to resubmitting the BLA for NexoBrid by mid-year, with an anticipated appr...