MDWD MediWound Ltd.

3.56
+0.06  (+2%)
Previous Close 3.5
Open 3.5
52 Week Low 3.1
52 Week High 6.22
Market Cap $96,993,727
Shares 27,245,429
Float 15,908,179
Enterprise Value $79,970,001
Volume 73,621
Av. Daily Volume 257,944
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Upcoming Catalysts

Drug Stage Catalyst Date
MW005
Basal Cell Carcinoma
Phase 1/2
Phase 1/2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
EscharEx
Lower leg ulcers
Phase 2
Phase 2
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EscharEx
Venous leg ulcers (VLU’s)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
NexoBrid (CIDS)
Severe burns - pediatric
Phase 3
Phase 3
Phase 3 top-line data met primary endpoints - July 20, 2021.
NexoBrid
Severe burns
CRL
CRL
CRL announced June 29, 2021.

Latest News

  1. YAVNE, Israel, Sept. 03, 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 that management will present at the following investor conferences during the month of September 2021.

    2021 Wells Fargo Virtual Healthcare Conference
    Date: Thursday, September 9, 2021
    Presentation Time: 8:00 a.m. Eastern Time

    H.C. Wainwright 23rd Annual Global Investment Conference
    On-demand corporate presentation is available beginning at 7:00 AM ET on Monday, September 13, 2021

    A live webcast of each event will be available on the Events page of the Investors section of the Company's website: www.mediwound.com

    YAVNE, Israel, Sept. 03, 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 that management will present at the following investor conferences during the month of September 2021.

    2021 Wells Fargo Virtual Healthcare Conference

    Date: Thursday, September 9, 2021

    Presentation Time: 8:00 a.m. Eastern Time

    H.C. Wainwright 23rd Annual Global Investment Conference

    On-demand corporate presentation is available beginning at 7:00 AM ET on Monday, September 13, 2021

    A live webcast of each event will be available on the Events page of the Investors section of the Company's website: www.mediwound.com. A replay of each webcast will be available on the Company's website for approximately 30 days.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieManaging Director
    Chief Financial OfficerLifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com


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  2. 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…

    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 per share, for the second quarter of 2020.

    Adjusted EBITDA, as defined below, for the second quarter of 2021 was a loss of $2.0 million, compared with a loss of $2.1 million for the second quarter of 2020.

    Year-to-Date 2021 Financial Results

    Revenues for the first half of 2021 were $11.9 million compared with $8.5 million in the first half of 2020, an increase of 41%. Product revenues in the first half of 2021 were $5.9 million, an increase of 224% compared to $1.8 million for the first half 2020. .

    Operating loss for the first half of 2021 was $4.8 million, compared with an operating loss of $4.9 million in the first half of 2020.

    The Company's net loss for the first half of 2021 was $6.0 million or $0.22 per share compared with net loss of $5.6 million or $0.20 per share for the first half of 2020.

    Adjusted EBITDA, for the first half of 2021, was a loss of $3.3 million, compared with a loss of $3.9 million for the first half of 2020.

    Balance Sheet Highlights

    As of June 30, 2021, MediWound had $17.2 million in cash and short-term investments, compared with $21.6 million as of December 31, 2020, and no debt. MediWound remained on budget, utilizing $4.4 million in the first half of 2021 for its operational activities. Throughout the remainder of 2021, the company will continue to invest primarily in research and development efforts for EscharEx, while the planned NexoBrid BLA resubmission and its related ongoing development programs will be funded by BARDA. We now expect cash use for 2021 to be in the range of $9.0 to $11.0 million.

    Conference Call

    MediWound management will host a conference call for investors today, Thursday, August 10, 2021, 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.) 1 809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3782335. The call also will be webcast live on the Company's website at http://ir.mediwound.com/events-and-presentations.

    A replay of the call will be available on the Company website for 90 days at www.mediwound.com.

    Non-IFRS Financial Measures

    To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company's performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.

    Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management.

    However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company's operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; timing or likelihood of approval by the U.S. Food & Drug Administration (FDA) of a Biologics License Application (BLA) for NexoBrid for treatment of severe burns in the United States following the receipt of a complete response for NexoBrid on June 28, 2021, the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA, including availability of funding from BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic on our business or the economy generally.

    For example, we are unable to predict how the COVID-19 pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and may impact the response times of governmental agencies, including the FDA, to future regulatory submissions and/or conduct necessary reviews or inspections of our manufacturing facilities, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of our products, including NexoBrid. Other disruptions or potential disruptions of the COVID-19 pandemic include restrictions on the ability of Company personnel to travel and access customers for training, promotion and case support, delays in product development efforts, and additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts or initiatives that may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.



    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com

    Jeremy Feffer

    Managing Director

    LifeSci Advisors 

    212-915-2568

    jeremy@lifesciadvisors.com

    MediWound, Ltd.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands

      June 30, December 31,
      2021 2020 2020
      Un-audited Audited
    Cash, cash equivalents and short term deposits 17,175 24,382 21,584
    Accounts and other receivable 2,948 3,492 3,229
    Inventories 1,397 1,934 1,380
    Total current assets 21,520 29,808 26,193
           
    Property, plant and equipment, net 2,565 2,326 2,630
    Right of use assets, net 1,789 2,086 1,884
    Intangible assets, net 330 396 363
    Total long-term assets 4,684 4,808 4,877
           
    Total assets 26,204 34,616 31,070
           
    Current maturities of long-term liabilities 1,681 1,321 1,750
    Trade payables and accrued expenses 4,060 2,423 2,992
    Other payables 3,920 6,040 3,524
    Total current liabilities 9,661 9,784 8,266
           
    Deferred revenues 405 1,174 1,234
    Liability in respect of Israeli Innovation Authority grants net of current maturity 7,671 7,130 7,267
    Liabilities in respect of purchase of shares net of current maturity 4,465 4,249 4,998
    Lease liability, net of current maturity 1,604 1,866 1,741
    Severance pay liability, net 280 281 292
    Total long-term liabilities 14,425 14,700 15,532
           
    Shareholders' equity 2,118 10,132 7,272
    Total liabilities & shareholder equity 26,204 34,616 31,070

    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE PROFIT (LOSS) (ANAUDITED)

    U.S. dollars in thousands

     Six months ended Three months ended
    June 30, June 30,
     2021  2020  2021  2020 
            
    Revenues11,904 8,465 6,057 4,027
    Cost of revenues7,127 6,018 3,696 2,810
    Gross profit 4,777 2,447 2,361 1,217
            
    Operating expenses:       
    Research and development4,898 3,331 2,656 1,612
    Selling, general & administrative4,695 4,028 2,600 2,311
    Operating loss(4,816) (4,912) (2,895) (2,706)
            
    Financial expenses, net(1,211) (645) (281) (390)
    Loss before tax on income(6,027) (5,557) (3,176) (3,096)
            
    Tax on income(19) - (19) -
    Loss for the period(6,046) (5,557) (3,195) (3,096)
    Foreign currency translation adjustments8 1 (3) (7)
    Total comprehensive loss(6,038) (5,556) (3,198) (3,103)
            
    Net loss per share(0.22) (0.20) (0.12) (0.11)
    Weighted average number of

    ordinary shares used in the

    computation of basic and diluted

    loss per share:
    27,241 27,207 27,211 27,052

    MediWound, Ltd.

    ADJUSTED EBITDA

    U.S. dollars in thousands

     Six months ended Three months ended
     June 30, June 30,
     2021  2020  2021  2020 
    Loss for the period(6,046) (5,557) (3,195) (3,096)
            
    Adjustments:       
    Financial expenses, net(1,211) (645) (281) (390)
    Tax on income(19) - (19) -
    Depreciation and amortization(627) (539) (354) (271)
    Share-based compensation expenses(884) (519) (500) (346)
    Total adjustments(2,741) (1,703) (1,154) (1,007)
    Adjusted EBITDA (3,305) (3,854) (2,041) (2,089)

    MediWound, Ltd.

    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    (UNAUDITED)

    U.S. dollars in thousands

      Six months ended Three months

    ended
      June 30, June 30,
      2021 2020 2021 2020
    Cash Flows from Operating Activities:        
    Net loss (6,046) (5,557) (3,195) (3,096)
    Adjustments to reconcile net loss to net cash used in operating activities:        
    Adjustments to profit and loss items:        
    Depreciation and amortization 627 539 319 271
    Share-based compensation 884 519 500 346
    Revaluation of liabilities in respect of IIA grants 497 424 222 226
    Revaluation of liabilities in respect of purchase of shares 299 348 147 196
    Revaluation of lease liabilities 35 64 79 100
    Increase (decrease) in severance liability, net (5) 40 5 19
    Financing income, net (11) (191) - (81)
    Unrealized foreign currency (gain) loss (226) 28 (482) (51)
      2,100 1,771 790 1,026
    Changes in asset and liability items:        
    Increase in trade receivables 680 1,341 3,087 444
    Decrease (increase) in inventories 17 (326) 62 65
    Increase in other receivables (432) (284) (469) (383)
    Increase (decrease) in trade payables and prepaid expenses 1,075 (1,649) 803 (1,004)
    Increase in other payables & deferred revenues (1,257) 86 (2,063) 133
      83 (832) 1,420 (745)
    Net cash used in operating activities (3,863) (4,618) (985) (2,815)
             
    Cash Flows from Investment Activities:        
    Purchase of property and equipment (244) (244) (26) (100)
    Interest received 35 42 - 39
    Proceeds from short term bank deposits, net of investments 4,002 10,595 (4) 7,603
    Net cash provided by (used in) investing activities 3,793 10,393 (30) 7,542
     



            
    Cash Flows from Financing Activities:        
    Repayment of lease liabilities (337) (313) (171) (153)
    Proceeds from IIA grants, net of repayments (180) (66) - -
    Net cash used in financing activities (517) (379) (171) (153)
             
    Exchange rate differences on cash and cash equivalent balances 204 (26) 495 57
    Increase (decrease) in cash and cash equivalents from activities (383) 5,370 (691) 4,631
    Balance of cash and cash equivalents at the beginning of the period 17,376 7,242 17,684 7,981
    Balance of cash and cash equivalents at the end of the period 16,993 12,612 16,993 12,612

     



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  3. YAVNE, Israel, Aug. 02, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that the Company will release its financial results for the second quarter ended June 30, 2021 at 7:00 am Eastern Time on Tuesday, August 10, 2021.

    Following the release, MediWound's management will host a conference call and live webcast on Tuesday, August 10, 2021 at 8:30 am Eastern Time to discuss the financial results, provide a corporate update and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details                 

    Toll-Free:877-602-7189
    Israel:1-809-315-362
    International:

    YAVNE, Israel, Aug. 02, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully integrated biopharmaceutical company focused on next-generation bio-therapeutic solutions for tissue repair and regeneration, today announced that the Company will release its financial results for the second quarter ended June 30, 2021 at 7:00 am Eastern Time on Tuesday, August 10, 2021.

    Following the release, MediWound's management will host a conference call and live webcast on Tuesday, August 10, 2021 at 8:30 am Eastern Time to discuss the financial results, provide a corporate update and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details                 

    Toll-Free:877-602-7189
    Israel:1-809-315-362
    International:678-894-3057
    Conference ID:3782335
    Webcast:https://edge.media-server.com/mmc/p/f27uaqvy

    To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call.  An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair. NexoBrid®, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.

    MW005, is a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Contacts: 
    Boaz Gur-Lavie 

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com 

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com 



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  4. Independent Data Monitoring Committee Recommends Continuation of the Study with
    No Changes to Study Sample Size

    No Safety Concerns Identified

    Full Study Enrollment Expected by Year-End 2021; Data Readout Expected in the First Half of 2022

    YAVNE, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced a positive outcome from a planned interim sample size re-estimation of its ongoing EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs), designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control…

    Independent Data Monitoring Committee Recommends Continuation of the Study with

    No Changes to Study Sample Size

    No Safety Concerns Identified

    Full Study Enrollment Expected by Year-End 2021; Data Readout Expected in the First Half of 2022

    YAVNE, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced a positive outcome from a planned interim sample size re-estimation of its ongoing EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs), designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).

    Based on the Independent Data Monitoring Committee's (IDMC) recommendation, no changes to the original enrollment target of 120 patients is required to maintain the pre-specified statistical power of 80 percent or greater on the study's primary endpoint of incidence of complete debridement compared with gel vehicle. In addition, the IDMC reviewed the data of all subjects treated and no safety concerns were identified in the study population. The IDMC's recommendations were based on the results of a pre-specified interim conditional power assessment conducted after approximately two-thirds of the originally targeted of 120 patients completed the debridement treatment.

    "We are very pleased with the IDMC's recommendation to continue the EscharEx study as originally planned without modifying the study sample size," said Sharon Malka, Chief Executive Officer of MediWound. "This interim outcome suggests that EschareEx is safe and tolerable, and increases our confidence that EscharEx may prove to be an effective non-surgical therapy for debridement of chronic wounds. With a clear unmet medical need for a non-surgical rapid and effective debridement agent in the outpatient setting, EscharEx has the potential to improve on the current standard of care and have a meaningful impact on chronic wound management. We remain on track to complete patient enrollment by year-end, with data readout expected in the first half of 2022."

    The multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs. The study is expected to enroll 120 patients at approximately 20 clinical sites, primarily in the U.S. Study participants are randomized to either EscharEx, placebo control or non-surgical standard-of-care of either enzymatic or autolytic debridement, at a ratio of 3:3:2, with a three-month follow-up. The study includes a pre-defined interim assessment for futility and potential sample size adjustment. The primary endpoint is incidence of complete debridement compared to gel vehicle placebo control. Secondary endpoints include time to achieve complete debridement, reduction of pain, reduction of wound area, granulation tissue and quality of life. Incidence and time to achieve wound closure will be assessed as safety measurements.

    About EscharEx

    EscharEx, our bioactive therapy for debridement of chronic and other hard-to-heal wounds, is a product candidate in advanced stages of clinical development. EscharEx, a concentrate of proteolytic enzymes enriched in bromelain, is an easy-to-use product candidate, for topical daily applications, which designed for the outpatient setting.

    In two phase 2 trials, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only few daily applications. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleave and remove the necrotic tissue and prepare the wound bed for healing. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's Annual Report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieJeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com



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  5. Data Expected End of 2021

    Phase II Investigator-Initiated Trial in Non-Melanoma Skin Cancers Running in Parallel

    YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021.

    The phase I/II open-label, randomized clinical study is designed to…

    Data Expected End of 2021

    Phase II Investigator-Initiated Trial in Non-Melanoma Skin Cancers Running in Parallel

    YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021.

    The phase I/II open-label, randomized clinical study is designed to evaluate the safety and tolerability of MW005 in BCC using different schedules of administration, as well as to provide a preliminary evaluation of its efficacy, as measured by the percentage of target lesions with complete histological clearance. The study will enroll up to 32 patients with histologically confirmed superficial or nodular BCC and will be conducted at three leading clinical centers in the United States.

    The phase II investigator-initiated trial is an open-label study, designed to evaluate the safety and efficacy of MW005 in removing non-melanoma skin cancers and pre-cancerous lesions (e.g., actinic keratosis, BCC, and squamous cell carcinoma) in up to 50 patients.

    "Most low-risk BCCs are treated surgically. There is a clear unmet need for an effective, non-surgical, topically-applied, short duration treatment for low-risk BCC, with less severe local skin reactions associated with current topical therapies," said Dr. Brian Berman, past president of American Dermatological Association, Professor Emeritus, University of Miami, and a lead principal investigator of the phase I/II study. "We are pleased to lead the clinical evaluation of MW005 as a potentially impactful topical therapy for low-risk BCC, given its pro-apoptotic mechanism of action and preliminary proof-of-concept efficacy."

    "We are excited to initiate this U.S. phase I/II study of MW005, which is the first step in this important clinical development program. MW005 represents a meaningful progress in our strategy to leverage our innovative enzymatic technology platform to pioneer solutions for unmet medical needs," said Sharon Malka, Chief Executive Officer of MediWound. "We are encouraged by the interest expressed by the clinical community to participate in this study, and we look forward to working closely with practitioners and patients as we advance this program to potentially treat the most common form of human cancer."

    BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the American Cancer Society, BCC is the most diagnosed skin cancer in the United States with approximately 4.3 million cases diagnosed every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy.

    About MW005

    MW005, a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development. MW005 is based on a proprietary formulation, designed to ease self-administration by the patients, and is based on the same active substance as in NexoBrid® and EscharEx®, a concentrate of proteolytic enzymes enriched in bromelain.

    The clinical development program of MW005 is supported by results from several toxicological and other preclinical studies, as well as the vast clinical experience with NexoBrid and EscharEx. In addition, a recently-published case series, wherein MW005 (a concentrate of proteolytic enzymes enriched in bromelain) was used for destruction of basal cell carcinoma, provides a preliminary clinical proof-of-concept that MW005 may be a safe and effective treatment in this indication.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burns, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including MW005. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieManaging Director
    Chief Financial OfficerLifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com


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