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MediWound Reports Second Quarter Financial Results
Second Quarter Revenues of $6.1 Million - Increase of 50% Year-over-Year Positive Interim Assessment Outcome for EscharEx U.S. Phase II Clinical Study No
About this update from Mediwound Ltd.
[{"type":"text","content":"Second Quarter Revenues of $6.1 Million - Increase of 50% Year-over-Year Positive Interim Assessment Outcome for EscharEx U.S. Phase II Clinical Study No Changes to Study Sample Size – No Safety Concerns Identified Conference call begins today at 8:30 am ET YAVNE, Israel, Aug. 10, 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 second quarter ended June 30, 2021. Second Quarter and Recent Weeks Corporate and Financial Highlights: Total revenues for the second quarter of 2021 were $6.1 million, an increase of 50% compared with the second quarter of 2020The Company had $17.2 million in cash and short-term investments as of June 30, 2021Positive 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; full study enrollment expected by year-end 2021 and data readout expected in the first half of 2022Received a Complete Response Letter (CRL) from U.S. FDA for NexoBrid biologics license application (BLA); working together with our partners, Vericel and BARDA, towards BLA resubmissionPositive top line results from phase III pediatric study (CIDS) for eschar removal of severe thermal burns; met all primary endpoints with a high degree of statistical significance, as well as certain secondary endpoints; the study showed NexoBrid to be safe and well toleratedInitiated 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 by year-end of 2021 “The second quarter of 2021 and the subsequent weeks, have been eventful with positive interim assessment for EscharEx phase II clinical study, FDA feedback on our NexoBrid BLA and positive top line results from NexoBrid phase III pediatric study,” said Sharon Malka, Chief Executive Officer of MediWound. “Moving forward with the best possible outcome of the interim assessment for our U.S. phase II adaptive design study of EscharEx, we have made significant progress in advancing our EscharEx development program, and we look forward to additional sign...