 Submitted Biological License Application to the FDA for NexoBrid EscharEx U.S. Phase 2 Study Resumed Patient ScreeningYAVNE, Israel, Aug. 06, 2020 GLOBE NEWSWIRE -- MediWound Ltd. Nasdaq: MDWD the Company, a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the second quarter ended June 30, 2020 and provided business and financial updates related to the COVID-19 pandemic. Second Quarter Business and Financial Highlights: Revenues for the second quarter of 2020 were 4.0 million, compared with 20.7 million for the second quarter of 2019, which included the upfront payment of 17.5 million from the Vericel licensing agreement The Company had 24.4 million in cash and short-term investments as of June 30, 2020, compared with 29.5 million as of December 31, 2019 Resumed patient screening and randomization in U.S. EscharEx phase 2 adaptive design study for the treatment of venous leg ulcers VLUs; Interim assessment is anticipated in the first half of 2021 Submitted Biologics License Application BLA to the U.S. Food and Drug Administration FDA for NexoBrid for the treatment of severe thermal burns in adults Instituted a series of measures to address challenges associated with the COVID-19 pandemic, while maintaining workforce and operational capacity and flexibilityWe are pleased to have submitted the BLA for NexoBrid on schedule despite the disruptions of the COVID-19 pandemic. This submission is a major milestone in our long-term partnership with BARDA, and we are actively preparing for the commercial launch with our partner, Vericel, upon approval, said Sharon Malka, Chief Executive Officer of MediWound. In addition, we are actively recruiting and enrolling patients in our U.S. EscharEx phase 2 study, and we are encouraged to see progress in moving this trial forward.Mr. Malka concluded, In recent months, humanity is facing tremendous challenges with a great deal of uncertainty. We are privileged to be among those tasked with improving patients quality of care and impacting their lives. Our solid balance sheet continues to support our growth as we execute on our strategic plans, and we are optimistic that we will continue to successfully strengthen our Company.Corporate UpdateMediWound has implemented several measures to safeguard the health and well-being of its employees, their families, and healthcare providers. The Company has reduced expenses to minimize impact to operations while ensuring full compliance with all necessary regulations. Management continues to assess the impact of the pandemic, the potential implications to business continuity, and necessary remedies and will adjust accordingly to the challenges created by any directives from regulatory authorities.The Company continues to manufacture and supply NexoBrid to patients with severe burn injuries, including manufacturing NexoBrid and building an emergency stockpile for the U.S. Biomedical Advanced Research and Development Authority BARDA, while the first delivery to BARDA is planned in the third quarter of 2020. The Company maintains a significant safety stock of all key raw materials and NexoBrid inventory to meet expected demand over the next several quarters. At this time, the Company does not expect any disruptions to its manufacturing operations and global supply chain. The Company submitted a BLA to the U.S. FDA seeking the approval of NexoBrid for eschar removal debridement in adults with deep partial-thickness and full-thickness thermal burns. The BLA submission is based on multiple preclinical and clinical studies including the pivotal Phase 3 U.S. clinical study DETECT of NexoBrid in adult patients with severe thermal burns. Vericel Corporation NASDAQ: VCEL holds an exclusive license for North American commercial rights of NexoBrid. MediWound is eligible to receive a 7.5 million milestone payment from Vericel upon BLA approval. On the clinical front, the Company has resumed new patients screening and randomization in its U.S. EscharEx phase 2 adaptive design study for the treatment of VLUs and expects to achieve the pre-defined interim assessment in the first half of 2021. In addition, enrollment in the NexoBrid expanded access NEXT program continues with enhanced safety measures, such as remote visits and virtual tools.The Company had 24.4 million in cash and short-term investments as of June 30, 2020, compared with 29.5 million as of December 31, 2019, with no debt. The Company reiterates its expectations of cash use for operating activities in 2020 to be in the range of 8 to 10 million. At this time, the Company cannot predict the extent or duration of the impact of the COVID-19 outbreak on its ongoing financial and operational results.Second Quarter Financial ResultsRevenues for the second quarter of 2020 were 4.0 million, compared with 20.7 million for the second quarter of 2019, which included the upfront payment of 17.5 million from the Vericel licensing agreement. Revenues from product in the second quarter of 2020 were 1.1 million, reflecting an increase of 17 in comparison to the second quarter of 2019, excluding the one-time upfront payment.Gross profit for the second quarter of 2020 was 1.2 million, compared to a gross profit of 17.5 million for the second quarter of 2019, which included 16.8 million from the Vericel licensing agreement. Research and development expenses for the second quarter of 2020, net of participations, were 1.6 million, compared with 0.4 million for the second quarter of 2019. The increase was primarily due to decrease of participation by BARDA and Israeli Innovation Authority IIA. Selling, general and administrative expenses for the second quarter of 2020 were 2.3 million, in line with the second quarter of 2019.Operating loss for the second quarter of 2020 was 2.7 million, compared with an operating profit of 13.9 million in the second quarter of 2019, which included the upfront payment of 17.5 million from the Vericel licensing agreement, net of royalty payment of 0.7 million and 0.8 million of other expenses. The Company posted a net loss of 3.1 million, or 0.11 per share, for the second quarter of 2020 compared with a net profit of 12.7 million, or 0.47 per share, for the second quarter of 2019, which included the 17.5 million upfront license payment, net of royalty payment of 0.7 million and 0.8 million of other expenses. Excluding the upfront license payment net of deal related costs, net loss for the second quarter of 2019 was 3.3 million, or 0.12 per share.Adjusted EBITDA, as defined below, for the second quarter of 2020 was a loss of 2.1 million, compared with a profit of 15.4 million for the second quarter of 2019, which included the upfront payment of 17.5 million from the Vericel licensing agreement, net of royalty payment of 0.7 million. Year-to-Date 2020 Financial ResultsRevenues for the first half of 2020 were 8.5 million compared with 21.2 million in the first half of 2019, which included the 17.5 million upfront payment from the Vericel licensing agreement for NexoBrid.The Companys net loss for the first half of 2020 was 5.6 million or 0.20 per share compared with net profit of 8.6 million or 0.32 per share for the first half of 2019, which included the 17.5 million upfront license payment, net of royalty payment of 0.7 million and 0.9 million of other expenses. Excluding the upfront license payment net of deal related costs, net loss for the first half of 2019 was 7.3 million, or 0.27 per share.Adjusted EBITDA, for the first half of 2020, was a loss of 3.9 million, compared with a profit of 12.4 million for the first half of 2019, which included the upfront payment of 17.5 million from the Vericel licensing agreement, net of royalty payment of 0.7 million. Conference CallMediWound management will host a conference call for investors today, Thursday, August 6, 2020 beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 in the U.S. 1809 315 362 Israel, or 678-894-3057 outside the U.S. Israel and entering passcode 3176168. The call also will be webcast live on the Companys website at replay of the call will be accessible two hours after its completion through August 27, 2020 by dialing 855-859-2056 in the U.S. or 404-537-3406 outside the U.S. and entering passcode 3176168. The call will also be archived on the Company website for 90 days at MediWound Ltd.MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWounds first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWounds second innovative product, EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit 