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MuMediWound MediWound Reports Second Quarter Financial Results August 10 , 2021 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 2020 • The Company had $ 17.2 million in cash and short - term investments as of June 30 , 2021 • Positive 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 2022 • Received 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 resubmission • Positive 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 tolerated • 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 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 significant clinical milestones in the months ahead as we complete enrollment in our phase II study and generate data from our phase II pharmacology study later this year . Chronic wounds impact millions of people worldwide and these important catalysts could advance us one step closer to bringing EscharEx to market as an improvement upon the current standard of care in chronic wound management . We are also excited to commence the clinical development program for MW005 in basal cell carcinoma with two phase II trials underway and look forward to providing further updates on their progress later this year . " Mr. Malka commented further " Though we were disappointed with the receipt of the NexoBrid CRL , we believe the FDA's comments can be addressed , and remain optimistic about the prospects of NexoBrid in the U.S. We are working closely with our partners Vericel and BARDA , to meet with the FDA as soon as possible and provide the FDA with a detailed response to the CRL . Regarding our CIDS pediatric phase III study , we were pleased with the robust clinical data generated , o which met all of its primary endpoints with highly statistically significant results , reinforcing the strong clinical safety and efficacy profile of NexoBrid . We believe that this data will further support our global expansion of NexoBrid as we continue to gain commercial traction in multiple geographies around the world . " Second Quarter Financial Results Revenues for the second quarter of 2021 were $ 6.1 million , compared with $ 4.0 million for the second quarter of 2020 , an increase of 50 % . Product revenues in the second quarter of 2021 were $ 3.0 million , an increase of 175 % compared to $ 1.1 million for the second quarter of 2020 , primarily driven by the procurement of NexoBrid by BARDA for emergency response preparedness and sales increase outside the U.S. Gross profit for the second quarter of 2021 was $ 2.4 million or 39 % of net revenues compared to a gross profit of $ 1.2 million or 30 % of net revenues for the second quarter of 2020 . Research and development expenses for the second quarter of 2021 were $ 2.7 million , compared with $ 1.6 million for the second quarter of 2020. The increase was primarily due to EscharEx clinical development program . Selling , general and administrative expenses for the second quarter of 2021 were $ 2.6 million , compared with $ 2.3 million in the second quarter of 2020. As a percentage of revenues , selling , general and administrative expenses for the second quarter decreased from 57 % in the second quarter of 2020 to 43 % in the second quarter of 2021 Operating loss for the second quarter of 2021 was $ 2.9 million , compared with an operating loss of $ 2.7 million in the second quarter of 2020 . The Company posted a net loss of $ 3.2 million , or $ 0.12 per share , for the second quarter of 2021 compared with a net loss of $ 3.1 million , or $ 0.11