MDWD

MediWound Ltd. Ordinary Shares NASDAQ Global Market
$4.92
Open: $4.68 High: $4.95 Low: $4.68 Close: $4.92
Range: 2021-06-23 - 2021-06-24
Volume: 279,076
Market: Open
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MDWD
MediWound Ltd. Ordinary Shares 42 Hayarkon Street Yavne , 8122745 http://www.mediwound.com
MediWound Ltd is a biopharmaceutical company engaged in developing, manufacturing and commercializing novel products to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds, connective tissue disorders and others.
  • CEO: Gal Cohen
  • Employees: 76
  • Sector: Healthcare
  • Industry: Biotechnology
MDWD News
Latest news about the MDWD
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  • MediWound Completes Patient Enrollment for Interim Assessment of its U.S. EscharEx Phase 2 Adaptive Design Study

    Interim Assessment Expected by end of July 2021 and Completion of Enrollment by Year-End 2021YAVNE, Israel, June 09, 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 that the enrollment target of patients for an interim assessment of its EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs) has been achiev

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  • MediWound Announces Peer-Reviewed Paper of a Case Series Report of Basal Cell Carcinoma Published in the Open Dermatology Journal

    Findings Provide Preliminary Proof-of-Concept Phase I/II Clinical Study in Basal Cell Carcinoma Scheduled to Begin in Second Quarter 2021, with Data Expected by the End of 2021 YAVNE, Israel, June 07, 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 a peer-reviewed publication of a case series report of basal cell carcinoma (BCC) destru

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  • MediWound (MDWD) Reports Q1 Loss, Tops Revenue Estimates

    MediWound (MDWD) delivered earnings and revenue surprises of 16.67% and 10.32%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?

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  • MediWound Reports First Quarter 2021 Financial Results

    First Quarter Revenues of $5.8 Million, an Increase of 32% Year-over-Year Conference call begins today at 8:30 am ET YAVNE, Israel, May 05, 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 financial results for the first quarter ended March 31, 2021. First Quarter and recent weeks Financial and Business Highlights: Total revenues for the first quarter of 2021 were $5.8 million, an increase of 32% compared with the first quarter of 2020, primarily driven by the procurement of NexoBrid® by the Biomedical Advanced Research and Development Authority (BARDA) Cash and short-term investments of $17.9 million as of March 31, 2021, compared with $21.6 million as of December 31, 2020 Hosted an Analyst Day on March 30 highlighting EscharEx® as an enzymatic debridement agent for chronic wounds featuring presentations by key opinion leaders. Enrolled the first patient in phase 2 pharmacology study of EscharEx, with data expected in the second half of 2021 Submitted a protocol to the U.S. Food and Drug Administration (FDA) for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma; study initiation is planned for the second quarter of 2021 Received marketing approval for NexoBrid in Chile and the Republic of China (Taiwan) and continue global expansion strategy with new distribution agreements in Europe and Asia “This quarter was one of continued progress across the board, highlighted by the continued revenue growth and NexoBrid global expansion, the enrollment of the first patient in our phase 2 pharmacology study of EscharEx, and the initiation of a new clinical program in non-melanoma skin cancer,” said Sharon Malka, Chief Executive Officer of MediWound. “We were proud to host an analyst day webinar in March on EscharEx, featuring four prominent key opinion leaders who discussed the current U.S. wound debridement practices and how EscharEx, upon approval, has the potential to change current standard of practice and care of chronic wounds. We continue to advance our U.S. phase 2 adaptive design study of EscharEx for the treatment of venous leg ulcers and look forward to an interim assessment later this year. Finally, we remain focused on continuing to drive revenue growth and further strengthen our company." First Quarter Financial Results Revenues for the first quarter of 2021 were $5.8 million, compared with $4.4 million for the first quarter of 2020, an increase of 32%. Revenues from products and licenses in the first quarter of 2021 were $2.9 million, an increase of 300% compared to the first 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 first quarter of 2021 was $2.4 million, or 41% of net revenues, compared to a gross profit of $1.2 million, or 28% of net revenues for the first quarter of 2020. Research and development expenses for the first quarter of 2021, were $2.2 million, compared with $1.7 million for the first quarter of 2020. The increase was a result of EscharEx clinical development program. Selling, general and administrative expenses for the first quarter of 2021 were $2.1 million, compared with $1.7 million in the first quarter of 2020 as a result of directors and officer’s insurance cost increase. As a percentage of revenues, selling, general and administrative expenses for the first quarter decreased from 39% in the first quarter of 2020 to 36% for the first quarter of 2021. Operating loss for the first quarter of 2021 was $1.9 million, reflecting a 13% decrease in operating loss compared to the $2.2 million in the first quarter of 2020. The Company posted a net loss of $2.9 million, or $0.10 per share, for the first quarter of 2021 compared with a net loss of $2.5 million, or $0.09 per share, for the first quarter of 2020. Adjusted EBITDA, as defined below, for the first quarter of 2021 was a loss of $1.3 million, compared with a loss of $1.8 million for the first quarter of 2020, reflecting a decrease in adjusted EBIDTA loss of 28%. Balance Sheet Highlights As of March 31, 2021, MediWound had $17.9 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 $3.7 million in the first quarter of 2021 for its operational activities. The Company expects cash use for 2021 to be in the range of $5.0 to $7.0 million. Conference Call MediWound management will host a conference call for investors today, Wednesday, May 5, 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 3496059. 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 MeasuresTo 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 is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair. NexoBrid, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by 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. MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com. About BARDA Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal Phase 3 pediatric clinical study (CIDS) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States and readiness for emergencies. For more information, refer to www.phe.gov/about/BARDA. Cautionary Note Regarding Forward-Looking StatementsMediWound 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. 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 FefferBoaz Gur-Lavie Managing DirectorChief Financial Officer LifeSci AdvisorsMediWound Ltd. 212-915-2568ir@mediwound.com jeremy@lifesciadvisors.com MediWound, Ltd.CONDENSED CONSOLIDATED BALANCE SHEETSU.S. dollars in thousands March 31, December 31, 2021 2020 2020 Un-audited Audited Cash, cash equivalents and short term deposits 17,862 27,311 21,584 Accounts and other receivable 5,574 3,540 3,229 Inventories 1,470 2,004 1,380 Total current assets 24,906 32,855 26,193 Property, plant and equipment, net 2,694 2,339 2,630 Right of use assets, net 1,747 2,191 1,884 Intangible assets, net 347 413 363 Total long term assets 4,788 4,943 4,877 Total assets 29,694 37,798 31,070 Current maturities of long-term liabilities 1,884 1,417 1,750 Trade payables and accrued expenses 3,258 3,423 2,992 Other payables 5,172 5,843 3,524 Total current liabilities 10,314 10,683 8,266 Deferred revenues 693 1,018 1,234 Liabilities in respect of Israeli Innovation Authority grants net of current maturities 7,275 6,942 7,267 Liabilities in respect of purchase of shares net of current maturities 4,733 4,097 4,998 Lease liabilities, net of current maturities 1,590 1,905 1,741 Severance pay liability, net 273 264 292 Total long term liabilities 14,564 14,226 15,532 Shareholders' equity 4,816 12,889 7,272 Total liabilities & shareholder equity 29,694 37,798 31,070 MediWound, Ltd.CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED)U.S. dollars in thousands Three months endedMarch 31, 2021 2020 Revenues 5,847 4,438 Cost of revenues 3,431 3,208 Gross profit 2,416 1,230 Operating expenses: Research and development 2,242 1,719 Selling, general and administrative 2,095 1,717 Operating loss (1,921) (2,206)Financial income 11 239 Financial expense (941) (494)Loss for the period (2,851) (2,461) Foreign currency translation adjustments 11 8 Total comprehensive loss (2,840) (2,453) Basic and diluted loss per share: Net loss per share (0.10) (0.09)Weighted average number of ordinary shares used in the computation of basic and diluted loss per share: 27,237 27,211 ADJUSTED EBITDAU.S. dollars in thousands Three months ended March 31, 2021 2020 Loss for the period (2,851) (2,461)Adjustments: Financial expenses, net (930) (255)Depreciation and amortization (273) (268)Share-based compensation expenses (384) (173)Total adjustments (1,587) (696)Adjusted EBITDA (1,264) (1,765) MediWound, Ltd.CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW (UNAUDITED)U.S. dollars in thousands Three months endedMarch 31, 2021 2020 Cash Flows from Operating Activities: Net loss (2,851) (2,461) Adjustments to reconcile net loss to net cash provided by (used in) operating activities: Adjustments to profit and loss items: Depreciation and amortization 273 268 Share-based compensation 384 173 Revaluation of liabilities in respect of IIA grants 275 198 Revaluation of liabilities in respect of purchase of shares 152 152 Revaluation of lease liabilities (44) (36)Increase (decrease) in severance liability, net (10) 21 Financing income (11) (110)Unrealized foreign currency (gain) loss 256 79 1,275 745 Changes in asset and liability items: Decrease (increase) in trade receivables (2,407) 897 Increase in inventories (45) (391)Decrease in other receivables 37 99 Increase (decrease) in trade payables & accrued expenses 272 (645)Increase (decrease) in other payables & deferred revenues 806 (47) (1,337) (87)Net cash used in operating activities (2,913) (1,803) Cash Flows from Investment Activities: Purchase of property and equipment (218) (144)Interest received 35 3 Proceeds from short term bank deposits, net of investments 4,006 2,992 Net cash provided by investing activities 3,823 2,851 Cash Flows from Financing Activities: Repayment of lease liabilities (131) (160)Repayment of IIA grants (180) (66)Net cash used in financing activities (311) (226) Exchange rate differences on cash and cash equivalent balances (291) (83)Increase in cash and cash equivalents 308 739 Balance of cash and cash equivalents at the beginning of the period 17,376 7,242 Balance of cash and cash equivalents at the end of the period 17,684 7,981

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  • MediWound Ltd. to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / May 5, 2021 / MediWound Ltd. (NASDAQ:MDWD) will be discussing their earnings results in their 2021 First Quarter Earnings call to be held on May 5, 2021 at 8:30 AM Eastern Time.

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  • Analysts Estimate MediWound (MDWD) to Report a Decline in Earnings: What to Look Out for

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  • MediWound to Report First Quarter 2021 Financial Results and Host a Conference Call and Webcast on May 5, 2021

    YAVNE, Israel, April 26, 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 first quarter ended March 31, 2021 at 7:00 am Eastern Time on Wednesday, May 5, 2021. Following the release, MediWound's management will host a conference call and live webcast on Wednesday, May 5, 2021 at 8:30 am Eastern Time to discuss the financial results and provide corporate update, and to answer questions. Dial-in and call details are as follows: Conference Call & Webcast DetailsToll-Free:877-602-7189Israel Toll-Free:1 809 315 362International:678-894-3057Conference ID:3496059Webcast:https://edge.media-server.com/mmc/p/7zehu5pu 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 is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair. NexoBrid®, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by 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. MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. 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-LavieJeremy FefferChief Financial OfficerManaging Director, LifeSci AdvisorsMediWound Ltd.212-915-2568ir@mediwound.comjeremy@lifesciadvisors.com

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  • MediWound Enrolls First Patient in Phase 2 Pharmacology Study of EscharEx

    Data Expected Second-Half 2021YAVNE, Israel, April 22, 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 it has enrolled the first patient in its phase 2 pharmacology study of EscharEx®, its next-generation enzymatic debridement agent under development for chronic wounds, with data expected in the second half of 2021. The pharmacology study, to be conducted in 2-3 U.S. clinical sites, is a phase 2 prospective, open label, single arm study. The objective of the study is to evaluate the clinical performance, safety, and pharmacology effect of EscharEx in debridement of lower leg ulcers (venous leg ulcers and diabetic foot ulcers) in up to 15 patients. Data collection includes the effects on biofilm burden and wound inflammation, as well as the impact of EscharEx on wound healing progression. “Chronic wounds represent a significant unmet medical need for many patients, and EscharEx, with its positive safety and efficacy results generated in our previous phase 2 studies, can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals and payers,” said Sharon Malka, Chief Executive Officer of MediWound. “We anticipate data from the pharmacology study in the second half of this year, in addition to the interim assessment in our EscharEx phase 2 adaptive design study.” “There is wide consensus among clinicians that infection and microbial biofilm impedes the healing process and prolongs wound healing. The treatment of biofilm in chronic wounds is rapidly becoming a primary objective of wound care,” said Dr. Robert Snyder, Chief Medical Director of EscharEx program. “EscharEx may convert a chronic wound into one that is acute while also disrupting biofilm and planktonic bacteria, which could delay wound healing.” About EscharExEscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds. In two phase 2 trials, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleaves and removes 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 Biofilm1 Biofilm is created through the attachment of bacteria to elements in the extracellular polymeric substances (EPS). The EPS, which is 50% to 90% of the total biofilm organic matter, is comprised of dead host tissue, microorganisms’ secretions, proteins, nucleic acids, lipids, and polysaccharides. Biofilms have been reported to interfere with normal wound healing, apparently by ‘locking’ the wound bed into a chronic inflammatory state that leads to elevated levels of tissue-degrading proteases and reactive oxygen species which damage cells and molecules needed for healing. A large percentage of bacteria in biofilm communities are metabolically dormant, and low metabolic rates make antibiotics ineffective. The EPS substances and their interactions are targets for therapeutic biofilm elimination. Bacterial biofilms have been shown to prolong the inflammatory process, which is detrimental to wound healing because of the degradation of the growth factors required for cellular proliferation and migration necessary for wound healing. 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 is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.NexoBrid, our first commercialized product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a BLA was submitted to the FDA and was assigned a PDUFA target date of June 29, 2021. NexoBrid is supported by 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. MediWound’s third innovative product candidate, MWPC005, is a topical drug candidate under development for the treatment of non-melanoma skin cancer. 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 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 FefferBoaz Gur-LavieManaging DirectorChief Financial OfficerLifeSci AdvisorsMediWound Ltd.212-915-2568ir@mediwound.comjeremy@lifesciadvisors.com ____________________________ 1 Source: World Union of Wound Healing Societies (WUWHS), Florence Congress, Position Document. Management of Biofilm. Wounds International 2016

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  • Companies Like MediWound (NASDAQ:MDWD) Are In A Position To Invest In Growth

    We can readily understand why investors are attracted to unprofitable companies. By way of example, MediWound...

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  • MediWound Hosting Analyst Day Webinar on EscharEx – Enzymatic Debridement Agent for Chronic Wounds

    Webinar To Be Held on Tuesday, March 30th at 10am Eastern TimeYAVNE, Israel, March 24, 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 it will host an analyst day webinar on EscharEx®, MediWound’s enzymatic debridement agent for chronic wounds, on Tuesday, March 30, 2021 at 10am Eastern Time. The webinar will feature presentations by key opinion leaders (KOLs) Robert S. Kirsner, M.D., Ph.D., University of Miami; Adam J. Singer, M.D., Stony Brook University; and Robert J. Snyder, D.P.M., M.Sc., Barry University. The KOLs will discuss the current U.S. chronic wound debridement practices and how EscharEx, upon approval, has the potential to change the current standard of practice and care of chronic wounds, recent in vivo head-to-head comparator study results and the biofilm opportunity. Additionally, Ilina Sen, Life Sciences Sr. Director, Huron Consulting Group, will discuss the U.S. market research insight. Drs. Kirsner, Singer, and Snyder, and Ms. Sen will be available for a Q&A session following their formal presentations. Sharon Malka, MediWound's Chief Executive Officer, will provide a corporate update and an overview of the EscharEx development program. EscharEx is MediWound's next-generation bioactive topical therapeutic under development, for debridement of chronic and hard to heal wounds. EscharEx active ingredient (API) is a concentrate of proteolytic enzymes enriched in bromelain. In two Phase 2 studies, EscharEx was well-tolerated and showed significantly higher incidence of complete debridement of various chronic wounds and other hard-to-heal wounds compared with hydrogel vehicle within a few daily applications as well as comparable safety profile. EscharEx is an investigational product, currently under investigation in a U.S. phase 2 adaptive design study. To register for the webinar, please click here. Dr. Kirsner is Chairman and the endowed Harvey Blank Professor in the Dr. Phillip Frost Dermatology in the Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine. He is Chief of Dermatology at the University of Miami Hospital and Clinics and Jackson Memorial Hospital and directs the University of Miami Hospital Wound Center. Dr. Kirsner received his undergraduate degree from Texas A&M University, his medical degree from the University of Miami and a PhD in epidemiology from the University of Miami, after he completed his clinical training. His clinical training included internal medicine, a clinical and research fellowship in wound healing and dermatology at the University of Miami. His research interests include Wound Healing and Skin Cancer Epidemiology. Dr. Kirsner serves as academic editor of the journal Wound Repair and Regeneration and is on the editorial boards for a number of journals in dermatology and wound healing. He also serves in national leadership positions in both Wound Healing and Dermatology, including currently serving on the American Academy of Dermatology Board of Directors and the Wound Healing Society Board of Directors. In addition to career development awards, foundation, industry sponsored funding and CDC funding, he currently leads or is part of a number of NIH funded grants. Independent of books, book chapters and abstracts, he has published over 550 articles. Dr. Adam Singer is a Professor of Emergency Medicine and Vice Chairman for Research in the Department of Emergency Medicine at Stony Brook University. Dr. Singer is a world renown expert in wound care. He has extensive preclinical and clinical experience in burn and wound care. He has over 400 publications, many in high impact journals such as the New England Journal of Medicine and JAMA, including a recent review article on lower extremity ulcers in the NEJM. He has received millions of dollars in extramural funding from the NIH, DOD, BARDA and industry. He is on the editorial board of multiple journals and is the Editor-in-Chief of Clinical and Experimental Emergency Medicine. He has considerable experience with both NexoBrid and EscharEx in both humans and animal models. His preclinical data in the porcine model helped support the EMA approval of NexoBrid and he has studied the use of EscharEx in several animal models. He has been a PI for all studies of bromelain-based enzymatic debridement of burns and ulcers in the US. He has also served on several national and international organizations and committees related to wound care. Dr. Robert Snyder is Professor and Director of Clinical Research and Fellowship Director in Wound Care and Research at Barry University School of Podiatric Medicine. He is certified in foot and ankle surgery by the American Board of Podiatric Surgery and is also a board certified wound specialist. Dr Snyder is past-president of the Association for the Advancement of Wound Care and past-president of the American Board of Wound Management, the certifying body for Wound Care Specialists. In addition to his doctorate, he holds an MSc in Wound Healing and Tissue Science from Cardiff University School of Medicine. His expertise at Cardiff, Wales, was further acknowledged by appointment as Honorary Senior Lecturer. To constantly expand his knowledge and stay current in all aspects of healthcare, he has completed an MBA in Health Management. Dr. Snyder is a key opinion leader and sought after speaker, lecturing extensively throughout the United States and abroad. He has been recognized with many awards for his contribution to the profession. Dr. Snyder has published several book chapters and over 165 papers in peer reviewed and trade journals on wound care. He serves as Associate Editor for JAPMA and is on the editorial advisory boards of Wound Management & Prevention, Wounds and Podiatry Management. He is also a periodic reviewer for the Lancet and NEJM. He has been a Principal Investigator on more than 50 randomized controlled trials for innovative wound healing modalities and therapies. In 2018, Dr. Snyder was inducted as a Faculty Fellow of the Royal College of Physicians & Surgeons (Glasgow). Ilina Sen brings 15 years of experience in life sciences strategy consulting. Ms. Sen guides leadership teams through research and development (R&D) portfolio planning, licensing, merger and acquisition opportunity identification, prioritization and valuation, and commercial and market access strategies for products throughout their life cycle. Her experience spans across therapeutic areas, with a focus in oncology, immune/inflammatory disorders, renal disorder, cardiovascular diseases and rare diseases. She has served a range of organizations, including top global biopharmaceutical companies, smaller biotech companies, and diagnostic firms. Prior to joining Huron, Ms. Sen worked as a life sciences strategy senior consultant at Frankel Group for eight years. She has also worked as a consultant at Quintiles Transnational in its strategic research services group. She began her career as a research associate at the National Cancer Institute. Ms. Sen received a M.S. in Biotechnology with a concentration in Regulatory Affairs from Johns Hopkins University​ and a B.S. in Biology with a minor in Biomedical Engineering from Carnegie Mellon University. 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 is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair. NexoBrid®, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by 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. MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. 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 StatementsMediWound 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, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment and the completion of enrollment, the time of commencing the pharmacological study and the results , the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of 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 NexoBrid and EscharEx 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: Boaz Gur-Lavie Chief Financial OfficerMediWound Ltd. ir@mediwound.com Jeremy FefferManaging DirectorLifeSci Advisors212-915-2568jeremy@lifesciadvisors.com

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  • MediWound to Participate in Upcoming March Investment Conferences

    YAVNE, Israel, Feb. 25, 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 present at the following virtual investor conferences in March 2021: Cowen 41st Annual Health Care ConferenceDate:Tuesday, March 2Time:9:10 am ET Oppenheimer 31st Annual Healthcare ConferenceDate: Tuesday, March 16Time: 1:10 pm ET 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 is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair. NexoBrid®, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by 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. MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. 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 Jeremy FefferChief Financial Officer Managing Director, LifeSci AdvisorsMediWound Ltd.212-915-2568ir@mediwound.com jeremy@lifesciadvisors.com

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  • MediWound Reports Fourth Quarter and Full-Year 2020 Financial Results

    Fourth Quarter Revenues of $6.7 Million - Up 23%and Full-Year 2020 Revenues of $21.8 Million - Product Revenue Up 117% Conference call begins today at 8:30 am ET YAVNE, Israel, Feb. 25, 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 financial results for the fourth quarter and full-year ended December 31, 2020. Fourth Quarter and Full-Year 2020 Financial Highlights: Total revenues of $21.8 million for the full year of 2020.Total revenues of $6.7 million for the fourth quarter of 2020, an increase of 23% compared with $5.4 million for the fourth quarter of 2019, primarily driven by initiation of the Biomedical Advanced Research and Development Authority (BARDA) emergency stockpile procurement.The company had $21.6 million in cash and short-term investments as of December 31, 2020. Fourth Quarter and Full-Year 2020 Business Highlights: U.S. Food and Drug Administration (FDA) accepted for review the Company’s Biologics License Application (BLA) for NexoBrid® and assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.BARDA initiated the procurement of NexoBrid for emergency stockpile, valued at $16.5 million, with first deliveries accepted by BARDA in the third and fourth quarters of 2020, with additional deliveries planned through end of 2021. Completed enrollment in the company’s NexoBrid pivotal Phase 3 (CIDS) study; top-line data, including twelve-month follow-up safety data, are anticipated in the second half of 2021.Completed U.S Phase 3 (DETECT) study, including patient long-term safety follow-up; the twenty-four-month safety data of cosmesis and function was comparable across all study arms with no new safety signals observed.Continued NexoBrid global expansion with additional distribution agreements in France, Switzerland and other EU countries; entered the Middle Eastern market with the signing of a distribution agreement in the United Arab Emirates.Adjusted the U.S. phase 2 adaptive design study of EscharEx® for the treatment of venous leg ulcers (VLUs) enrollment target to 120 patients down from the 174 originally planned; interim assessment is expected in mid-2021 and completion of enrollment by year-end 2021.Launched a new clinical development program to evaluate its product candidate MWPC005 in patients with non-melanoma skin cancers; a U.S. phase I/II clinical study for the treatment of basal cell carcinoma (BCC) is scheduled to begin in the second quarter of 2021. “I am very proud of our team’s perseverance and resilience in delivering positive results in our clinical programs and financial performance despite the enormous COVID-19 challenges that we all face globally. We look forward to 2021 as a pivotal year of important catalysts for MediWound,” said Sharon Malka, Chief Executive Officer of MediWound. “We remain focused on our continued growth with the advancement of our EscharEx clinical program with a U.S phase 2 study interim assessment later this year. NexoBrid’s global expansion continues as we look forward to NexoBrid's BLA approval in 2021. Finally, we are excited to initiate the clinical development program of MWPC005 as a treatment for BCC, leveraging our platform technology to enhance our diverse and innovative portfolio.” Fourth Quarter Financial Results Revenues for the fourth quarter of 2020 were $6.7 million, compared with $5.4 million for the fourth quarter of 2019, an increase of 23%. Revenues from sale of product in the fourth quarter of 2020 were $2.8 million, reflecting an increase of 155% in comparison to the fourth quarter of 2019, primarily driven by BARDA emergency stockpile procurement. Gross profit for the fourth quarter of 2020 was $2.3 million and 35%, compared with a gross profit of $1.1 million and 20% for the fourth quarter of 2019. Gross margin from sale of products in the fourth quarter of 2020 was 56% in comparison to 32% for the fourth quarter of 2019. Research and development expenses for the fourth quarter of 2020, net of participations, were $2.2 million, compared with $1.7 million for the fourth quarter of 2019. The increase was primarily due to the ongoing EscharEx clinical development program. Selling, general and administrative expenses for the fourth quarter of 2020 were $2.5 million, stable with the $2.4 million for the fourth quarter of 2019. Operating loss for the fourth quarter of 2020 was $2.4 million, compared with an operating loss of $3.1 million in the fourth quarter of 2019, primarily as a result of revenue growth. The Company posted a net loss of $1.7 million, or $0.06 per share, for the fourth quarter of 2020 compared with a net loss of $3.4 million, or $0.13 per share, for the fourth quarter of 2019. Adjusted EBITDA, as defined below, for the fourth quarter of 2020 was a loss of $1.8 million, compared with a loss of $2.4 million for the fourth quarter of 2019. Full Year 2020 Financial Results Revenues for the year ended December 31, 2020 were $21.8 million compared with $31.8 million for the year ended December 31, 2019, which included a $17.5 million upfront payment from the Vericel license agreement for NexoBrid. Revenues from product for the full year of 2020 were $7.8 million, an increase of 117% compared with the full year of 2019, primarily driven by BARDA emergency stockpile procurement. Gross profit for the year ended December 31, 2020 was $7.5 million, compared with a gross profit of $19.9 million in the prior year period. Excluding the $17.5 million upfront license payment net of $0.7 million of deal related expenses, gross profit for the year ended December 31, 2019, was $3.1 million. Gross margin from sale of products for the full year of 2020 was 60% in comparison to 35% for the full year of 2019. Research and development expenses for the year ended December 31, 2020, net of participations, were $7.7 million, compared with $5.0 million in the prior year period. The increase was primarily as a result of the U.S. Phase 2 adaptive design study of EscharEx and a non-cash increase in participation from the Israeli innovation authority grant recorded in 2019. Selling, general and administrative expenses for the year ended December 31, 2020 were $8.7 million compared with $9.3 million in the prior year period. The decrease was primarily due to the Company’s headquarters’ restructuring in Europe. Operating loss for the year ended December 31, 2020 was $8.8 million compared to an operating profit of $4.5 million for the year ended December 31,2019, which included $17.5 million upfront license payment and $1.7 million of NexoBrid licensing deal related expenses. Excluding the upfront license payment, net of deal related costs, operating loss for full year of 2019 was $11.3 million. The Company’s net loss in 2020 was $9.2 million, or a loss of $0.34 per share, compared with a net profit of $5.0 million, or a profit of $0.18 per share for the same period in 2019, which included the $17.5 million upfront license payment and $1.7 million of NexoBrid licensing deal related expenses. Excluding the upfront license payment net of deal related costs, net loss for the year ended 2019 was $10.8 million, or $0.40 per share. Adjusted EBITDA, for the year ended December 31, 2020, was a loss of $6.4 million, compared with a profit of $8.0 million for the year ended December 31, 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of a royalty payment of $0.7 million. Balance Sheet Highlights The Company had $21.6 million in cash and short-term investments as of December 31, 2020, compared with $29.5 million as of December 31, 2019, with no debt. The Company utilized $7.9 million in cash to fund its ongoing operating activities and repayment of contingent liabilities during 2020, below its cash guidance for 2020 of $8.0 to $10.0 million. The Company expects cash use for 2021 to be in the range of $5.0 to $7.0 million. Conference Call MediWound management will host a conference call for investors today, Thursday, February 25, 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.) 1809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3049108. 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. 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 is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair. NexoBrid, our first commercialized product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a BLA was submitted to the FDA and was assigned a PDUFA target date of June 29, 2021. NexoBrid is supported by 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. MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com. About BARDA Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal Phase 3 pediatric clinical study (CIDS) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States and readiness for emergencies. For more information, refer to www.phe.gov/about/BARDA. 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, objectives, 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 preclinical studies and 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, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2020, 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-LavieChief Financial OfficerMediWound Ltd.ir@mediwound.com Jeremy FefferManaging DirectorLifeSci Advisors212-915-2568jeremy@lifesciadvisors.com MediWound, Ltd.CONDENSED CONSOLIDATED BALANCE SHEETSAUDITED U.S. dollars in thousands December 31, 2020 2019Cash, cash equivalents and short term deposits 21,584 29,458Accounts and other receivable 3,229 4,557Inventories 1,380 1,613Total current assets 26,193 35,628Property, plant and equipment, net 2,630 2,304Right of-use assets, net 1,884 2,229Intangible assets, net 363 429Total long term assets 4,877 4,962 Total assets 31,070 40,590 Current maturities of long-term liabilities 1,750 569Trade payables and accrued expenses 2,992 4,067Other payables 3,524 5,737Total current liabilities 8,266 10,373Deferred revenues 1,234 1,135Liabilities in respect of Israeli Innovation Authority grants net of current maturities 7,267 6,811Liabilities in respect of the purchase of shares 4,998 4,853Lease liabilities net of current maturities 1,741 2,006Severance pay liability, net 292 243Total long term liabilities 15,532 15,048 Shareholders' equity 7,272 15,169Total liabilities & shareholder equity 31,070 40,590 MediWound, Ltd.CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE PROFIT (LOSS) U.S. dollars in thousands Year ended Three months endedDecember 31, December 31, 2020 2019 2020 2019 AUDITED UNAUDITEDRevenues21,763 31,789 6,673 5,442 Cost of revenues14,218 11,849 4,345 4,360 Gross profit 7,545 19,940 2,328 1,082 Operating expenses: Research and development, net of participations7,698 4,969 2,225 1,676 Selling, general & administrative8,687 9,306 2,489 2,419 Other expenses (income), net- 1,172 - 131 Total operating expenses16,385 15,447 4,714 4,226 Operating profit (loss)(8,840) 4,493 (2,386) (3,144)Financial income (expenses), net(436) (2,427) 657 (382)Profit (loss) from discontinued operation80 2,889 (3) 83 Profit (loss) for the period(9,196) 4,955 (1,732) (3,443) Foreign currency translation adjustments(23) 8 (12) (9)Total comprehensive profit (loss)(9,219) 4,963 (1,744) (3,452) Profit (loss) per share: Profit (loss) from continuing operations(0.34) 0.08 (0.06) (0.13)Profit from discontinued operation- 0.10 - - Net profit (loss) per share(0.34) 0.18 (0.06) (0.13) Weighted average number of ordinary shares provided by (used in) the computation of basic and diluted profit (loss) per share (in thousands):27,210 27,203 27,213 27,179 ADJUSTED EBITDAU.S. dollars in thousand Year ended Three months ended December 31, December 31, 2020 2019 2020 2019Profit (loss) for the period(9,196) 4,955 (1,732) (3,443)Adjustments: Financial (expenses) income, net(436) (2,427) 657 (382)Profit (loss) from discontinued operation80 2,889 (3) 83 Other (expenses) income, net- (1,172) - (131)Depreciation and amortization(1,090) (1,149) (224) (301)Share-based compensation expenses(1,322) (1,234) (399) (303)Total adjustments(2,768) (3,093) 31 (1,034)Adjusted EBITDA (6,428) 8,048 (1,763) (2,409) MediWound, Ltd.CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWU.S. dollars in thousands Year ended Three months ended December 31, December 31, 2020 2019 2020 2019 AUDITED UNAUDITEDCash Flows from Operating Activities: Net profit (loss)(9,196) 4,955 (1,732) (3,443) Adjustments to reconcile net profit (loss) to net cash provided by (used in) continuing operating activities: Adjustments to profit and loss items: Loss (profit)from discontinued operation(80) (2,889) 3 (83)Depreciation and amortization1,090 1,149 224 301 Share-based compensation1,322 1,234 399 303 Revaluation of liabilities in respect of IIA grants828 (392) 136 (293)Revaluation of liabilities in respect of purchase of shares(433) 1,690 (991) 171 Revaluation of lease liabilities305 340 178 631 Increase (decrease) in severance liability, net33 (105) (2) (73)Financing income(297) (434) (53) (139)Unrealized foreign currency gain(211) (152) (203) (100) 2,557 441 (309) 718 Changes in asset and liability items: Decrease (increase) in trade receivables1,386 (3,553) (91) 402 Decrease (increase) in inventories141 67 372 (193)Decrease (increase) in other receivables(13) 6,376 384 1,178 Increase (decrease) in trade payables & accrued expenses(1,096) 1,355 (171) 1,205 Increase (decrease) in other payables & deferred revenues(479) 247 (1,767) (563) (61) 4,492 (1,273) 2,029 Net cash provided by (used in) continuing operating activities(6,700) 9,888 (3,314) (696)Net cash used in discontinued operating activities(195) (1,599) (3) (1,599)Net cash provided by (used in) operating activities(6,895) 8,289 (3,317) (2,295) Cash Flows from Investment Activities: Purchase of property and equipment(923) (792) (443) (329)Interest received274 184 231 80 Proceeds from (investment in) short term bank deposits, net of investments18,034 (5,050) 9,898 2,955 Net cash provided by (used in) continuing investing activities17,385 (5,658) 9,686 2,706 Net cash used in discontinued investing activities- (1,239) - (282)Net cash provided by (used in) investing activities17,385 (6,897) 9,686 2,424 Cash Flows from Financing Activities: Repayment of lease liabilities(508) (630) 25 (729)Repayment of IIA grants, net(121) (376) - - Net cash provided by (used in) financing activities(629) (1,006) 25 (729)Exchange rate differences on cash and cash equivalent balances273 140 241 99 Increase (decrease) in cash and cash equivalents from continuing activities10,329 3,364 6,638 1,380 Decrease in cash and cash equivalents from discontinued activities(195) (2,838) (3) (1,881)Balance of cash and cash equivalents at the beginning of the period7,242 6,716 10,741 7,743 Balance of cash and cash equivalents at the end of the period17,376 7,242 17,376 7,242

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  • MediWound Launches Clinical Development Program for Treatment of Non-Melanoma Skin Cancer

    Phase I/II Clinical Study in Basal Cell Carcinoma Scheduled to Begin Second Quarter 2021, with Data Expected by the End of 2021 An Investigator-Initiated Trial Will Run in Parallel YAVNE, Israel, Feb. 22, 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 the initiation of a new clinical development program to evaluate its drug product candidate MWPC005 in patients with non-melanoma skin cancer. MediWound recently submitted a protocol to the FDA for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma (BCC) and is preparing to initiate this study in the United States in the second quarter of 2021. A phase II investigator-initiated trial of MWPC005 in non-melanoma skin cancer will be conducted in parallel at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be generated by the end of 2021. MWPC005 is a topically applied biological drug candidate based on the same active ingredient as in the Company’s NexoBrid® and EscharEx® products, a concentrate of proteolytic enzymes enriched in bromelain. MediWound’s preclinical in-vitro research, combined with existing scientific evidence in a skin cancer model, demonstrated bromelain’s anti-cancer activity, and together with clinical case studies suggest that MWPC005 might have a role in treating low-risk non-melanoma skin malignancies. “I am pleased to launch our new clinical development program for the treatment of non-melanoma skin cancers. MWPC005 represents an important step in our strategic evolution to leverage our innovative enzymatic platform technology to pioneer solutions for unmet medical needs,” said Sharon Malka, Chief Executive Officer of MediWound. “Non-melanoma skin cancers, including BCC, are by far the most common of all types of cancer and represent a significant potential market opportunity. We believe that MWPC005 has the potential to be an effective non-invasive treatment for BCC without the side effects associated with current topical therapies and their longer treatment duration. While MediWound remains focused on its continued growth and advancement of our NexoBrid and EscharEx programs, we are excited to add a synergistic drug product candidate to our pipeline portfolio.” 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 diagnosed cases every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy. The phase I/II open-label, randomized clinical study of MWPC005 in BCC is designed to evaluate safety and tolerability using different schedules of administration, as well as provide a preliminary evaluation of efficacy as measured by the percentage of target lesion 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 U.S. The phase II investigator-initiated trial is an open-label study, designed to evaluate the safety and efficacy of MWPC005 in removing non-melanoma skin cancer and pre-cancerous lesions (e.g. actinic keratosis, BCC and squama cell carcinoma) in up to 50 patients. About MWPC005 MWPC005, is a topically applied biological product candidate based on the same active substance as in NexoBrid® and EscharEx® products, a concentrate of proteolytic enzymes enriched in Bromelain. MWPC005 is based on a proprietary formulation, designed to ease self-administration by the patients. The clinical development plan of MWPC005 is supported by the results from several toxicological and other preclinical studies, as well as the vast clinical experience from NexoBrid and EscharEx, which share the same active substance. 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 is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair. NexoBrid, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by 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. MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. 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, objectives, 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 preclinical studies and 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; 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, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2020, 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 FefferBoaz Gur-LavieManaging DirectorChief Financial OfficerLifeSci AdvisorsMediWound Ltd.212-915-2568ir@mediwound.comjeremy@lifesciadvisors.com

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  • MediWound to Report Fourth Quarter and Fiscal 2020 Financial Results and Host a Conference Call and Webcast on February 25, 2021

    YAVNE, Israel, Feb. 16, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release its financial results for the fourth quarter and year ended December 31, 2020 at 7:00 am Eastern Time on Thursday, February 25, 2021. Following the release, MediWound's management will host a conference call and live webcast on Thursday, February 25, 2021 at 8:30 am Eastern Time to discuss the financial results and to answer questions. Dial-in and call details are as follows: Conference Call & Webcast DetailsToll-Free: 877-602-7189Israel Toll-Free: 1 809 315 362International: 678-894-3057Conference ID: 3049108Webcast: https://edge.media-server.com/mmc/p/ooo4cb7t 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 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. MediWound’s 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 for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound’s 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. EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study. For more information, please visit www.mediwound.com. Contacts: Boaz Gur-Lavie Jeremy FefferChief Financial Officer Managing Director, LifeSci AdvisorsMediWound Ltd. 212-915-2568ir@mediwound.com jeremy@lifesciadvisors.com

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  • MediWound to Participate in the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference

    YAVNE, Israel, Feb. 10, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Sharon Malka, Chief Executive Officer, will participate in a fireside chat during the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference, which is being held February 17-19, 2021. Event DetailsDate:Thursday, February 18Time:11:30 am ET A live webcast of the fireside chat will be available on Events page of the Investors section of the company's website: www.mediwound.com. About 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. MediWound’s 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 for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound’s 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. EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study. For more information, please visit www.mediwound.com. Contacts: Boaz Gur-Lavie Jeremy FefferChief Financial Officer Managing Director, LifeSci AdvisorsMediWound Ltd. 212-915-2568ir@mediwound.comjeremy@lifesciadvisors.com

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  • MediWound (NASDAQ:MDWD) Shareholders Have Enjoyed A 59% Share Price Gain

    The simplest way to invest in stocks is to buy exchange traded funds. But one can do better than that by picking better...

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  • MediWound Provides Progress Update on Its EscharEx Clinical Development Program

    Phase 2 Adaptive Design Study Sample Size Reduced to 120 Patients Interim Assessment Expected in Mid-2021 and Completion of Enrollment by Year-End 2021Protocol Submitted to FDA for Pharmacology Clinical Study with Data Expected in Second Half 2021YAVNE, Israel, Jan. 11, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today provided an update on its EscharEx® clinical development program.Due to COVID-19 related enrollment delays and potentially future pandemic related implications on the conduct of its clinical studies, the company is accelerating its EscharEx phase 2 adaptive design study, for the treatment of venous leg ulcers (VLUs), by adjusting its enrollment target to 120 patients, down from the 174 originally planned. The sample size adjustment is supported by the assessment of the positive results generated in a recent in-vivo study, comparing EscharEx to a commercially enzymatic debriding agent, and the debridement efficacy results demonstrated in a previous phase 2 clinical study with first generation EscharEx. The company continues to actively recruit patients and reiterates its expectation for an interim assessment in mid-2021. As a result of the adjustment, study duration is expected to shorten and the company anticipates completing patient enrollment by year-end 2021.MediWound recently submitted a protocol to the FDA for a pharmacology study and is preparing to initiate this study in the first half of 2021. The study is an open label, single arm study assessing the pharmacological effects of EscharEx in up to 15 patients with VLUs or diabetic foot ulcers (DFUs), including the effects on biofilm burden and wound inflammation, as well as the impact of EscharEx on wound healing progression. The company anticipates reporting data from this study in the second half of 2021."We are very pleased with the progress we have made in our EscharEx development program in 2020, despite the challenges posed by the COVID-19 pandemic," said Sharon Malka, Chief Executive Officer of MediWound. "Chronic wounds present a significant unmet medical need for many patients, and we believe that EscharEx can have a meaningful impact on chronic wound management, offering significant benefits for patients, healthcare professionals and payers. We welcome 2021 with great anticipation and look forward to the pharmacology study data as well as the interim assessment and completion of patient enrollment in our phase 2 adaptive design study."About EscharEx EscharEx is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds. In two phase 2 trials, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. EscharEx active substance (API) is a concentrate of proteolytic enzymes enriched in bromelain. The mechanism of action of EscharEx is mediated by the proteolytic enzymes that cleaves and removes 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 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. MediWound’s 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 for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound’s 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 www.mediwound.com.Cautionary Note Regarding Forward-Looking StatementsMediWound 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, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment and the completion of enrollment, the time of commencing the pharmacological study and the results , the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of 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 NexoBrid and EscharEx 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, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2020, 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.comJeremy Feffer Jeremy Feffer Managing Director, LifeSci Advisors 212-915-2568 jeremy@lifesciadvisors.com

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  • MediWound to Participate in Upcoming Investor Conferences in January

    YAVNE, Israel, Jan. 05, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that it will participate in the forthcoming LifeSci Partners 10th Annual Corporate Access Event and the H.C. Wainwright BioConnect 2021 Conference. Both conferences will take place virtually. LifeSci Advisors Corporate Access Event (January 6-8 and 11-14) Management will be available for virtual 1x1 meetings with institutional investors and sell side analysts. To register for this event and request a meeting, visit: http://lifesci.events/LifeSci2021.H.C. Wainwright BioConnect 2021 Conference (January 11-14) Management will provide a corporate update. The session time is on-demand, beginning Monday January 11 starting 6:00 am (EST). To register and view the presentation, please click here.About 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. MediWound’s 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 for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. MediWound’s 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 www.mediwound.com.Cautionary Note Regarding Forward-Looking StatementsMediWound 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, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of pre-clinical and clinical trials and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of 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 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 NexoBrid 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, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2020, 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 Jeremy Feffer Managing Director, LifeSci Advisors 212-915-2568 jeremy@lifesciadvisors.com

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