Business
MediWound Reports Third Quarter 2021 Financial Results
Third Quarter Revenues of $6.4 Million; Year-to-Date 2021 Revenues Increased 21% Clarity on Regulatory Pathway for Resubmission of NexoBrid BLA, Anticipated
About this update from Mediwound Ltd.
[{"type":"text","content":"Third Quarter Revenues of $6.4 Million; Year-to-Date 2021 Revenues Increased 21% Clarity on Regulatory Pathway for Resubmission of NexoBrid BLA, Anticipated in Mid- 2022 EscharEx Phase 2 Program Top-Line Results Accelerated, Currently Expected in the First Quarter of 2022 Conference call begins today at 8:30 am ET YAVNE, Israel, Nov. 16, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the third quarter ended September 30, 2021. Third Quarter and Recent Corporate and Financial Highlights: Total revenues for the third quarter of 2021 were $6.4 million, compared to $6.6 million in the third quarter of 2020Total revenues for the first nine months of 2021 were $18.3 million, an increase of 21% compared to $15.1 million in the same period 2020The Company had $13.9 million in cash and short-term investments as of September 30, 2021 Following a productive Type A meeting with the U.S. Food and Drug Administration (FDA), the Company gained clarity on a path forward for resubmission of its NexoBrid® Biologics License Application (BLA), which is now anticipated in mid-2022Positive top line results from phase III pediatric study (CIDS) for eschar removal of severe thermal burns Completion of study enrollment in the EscharEx® U.S. phase II study for the treatment of venous leg ulcers (VLUs) expected by year-end with top-line data now expected in the first quarter of 2022Positive outcome of interim assessment for EscharEx U.S. phase II adaptive design study with no changes to study sample size of 120 patients and no safety concerns identified Announced peer-reviewed publication of EscharEx in-vivo head-to-head comparator study in the Journal of Wound Care, which showed EscharEx to be more effective than the commercially available collagenase product Initiated a U.S. phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC); phase II investigator-initiated trial in non-melanoma skin cancers running in parallel with data from both expected in the first half of 2022. “We are pleased with the progress we have made this quarter across our portfolio. We gained regulatory clarity on the pathway for resubmission of NexoBrid BLA, and we...