Page 1

My MediWound Mw MediWound Reports Third Quarter 2021 Financial Results November 16 , 2021 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 2020 • Total 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 2020 • The 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 - 2022 • Positive 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 2022 • 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 • 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 continue to advance significantly the clinical development programs of EscharEx , where we remain on track to complete patient enrollment of the U.S. phase 2 study for the treatment of VLUs and generate data from the phase 2 pharmacology study by year - end , " said Sharon Malka , Chief Executive Officer of MediWound . " As we approach the end of the year and look into 2022 , we remain optimistic about our programs and believe 2022 will be a very meaningful year , as we are moving towards important milestones in the coming quarters . We look forward to continuing to build on the momentum as we execute on our strategic goals . " Third Quarter Financial Results Revenues for the third quarter of 2021 were $ 6.4 million , a decrease of 4 % compared to $ 6.6 million for the third quarter of 2020 primarily due to decrease in revenues from development services provided to BARDA , and up 5 % sequentially . Gross profit for the third quarter of 2021 was $ 2.5 million with gross margins of 39 % , compared to gross profit of $ 2.8 million and gross margins of 42 % for the third quarter of 2020 . Research and development expenses for the third quarter of 2021 were $ 2.9 million , compared to $ 2.1 million for the third quarter of 2020. The increase in expenses was primarily due to clinical development for EscharEx . Selling , general and administrative expenses for the third quarter of 2021 were $ 2.4 million , compared to $ 2.2 million in the third quarter of 2020 . Operating loss for the third quarter of 2021 was $ 2.9 million , compared to an operating loss of $ 1.5 million in the third quarter of 2020 .