Tillkännagivande • May 29
MediWound Ltd. Reaffirms Revenue Guidance for the Full-Year 2026 MediWound Ltd. reaffirmed revenue guidance for the full-year 2026. The company reaffirmed its full-year 2026 revenue guidance of $24 million to $26 million, supported primarily by expected revenue from government-related development services during the second half of 2026. Reported Earnings • May 27
First quarter 2026 earnings released: US$0.23 loss per share (vs US$0.067 loss in 1Q 2025) First quarter 2026 results: US$0.23 loss per share (further deteriorated from US$0.067 loss in 1Q 2025). Revenue: US$1.48m (down 63% from 1Q 2025). Net loss: US$2.95m (loss widened 307% from 1Q 2025). Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has increased by 20% per year, which means it is well ahead of earnings. Tillkännagivande • May 07
MediWound Ltd. to Report Q1, 2026 Results on May 27, 2026 MediWound Ltd. announced that they will report Q1, 2026 results Pre-Market on May 27, 2026 Tillkännagivande • Apr 08
Mediwound Ltd. Presents New Escharex Data At Wound Care Conferences MediWound Ltd. announced multiple oral and poster presentations at three wound care conferences: the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2026, taking place April 8–12 in Charlotte, North Carolina, and the European Wound Management Association (EWMA) 2026, taking place May 6–8 in Bremen, Germany. The presentations will showcase new preclinical and clinical data supporting EscharEx’s differentiated mechanism of action, clinical performance, and advancement of its ongoing Phase III development in venous leg ulcers (VLUs), as well as its planned expansion into diabetic foot ulcers (DFUs) and pressure ulcers. A new preclinical mechanistic study demonstrated superior debridement with EscharEx versus SANTYL across multiple non-viable tissue components, while gene expression analysis revealed that EscharEx specifically activates molecular pathways that support wound healing. New analysis demonstrating improved long-term scar outcomes following enzymatic debridement compared to surgical and non-surgical standard of care. New data on time to wound closure following autograft or placental-derived allografts in VLUs, supporting the statistical assumptions of the ongoing VALUE Phase III study. Post-hoc analysis from the ChronEx Phase II multicenter randomized controlled trial highlighting that adequate wound bed preparation is a prerequisite for wound closure, supporting the co-primary endpoint of the VALUE Phase III study. Scientific session highlighting the expanding role of bromelain-based enzymatic therapy from acute burn care to chronic wound management, including clinical case studies, comparison to SANTYL, Phase III VALUE trial updates in VLUs, and future development in DFUs and pressure injuries. Post-hoc analysis demonstrates the efficacy of bromelain-based enzymatic debridement in DFUs, supporting ongoing development in this indication. Additional analyses from the ChronEx Phase II randomized controlled trial, further strengthening the clinical foundation for the ongoing VALUE Phase III study. EscharEx® is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily use, EscharEx has demonstrated effective wound bed preparation and a favorable safety profile in multiple Phase II studies. It enables rapid removal of non-viable tissue while promoting granulation and reducing bioburden and biofilm. The global Phase III VALUE trial in venous leg ulcers (VLUs) is underway, with clinical studies in diabetic foot ulcers (DFUs) and pressure ulcers (PUs) planned for H2 2026. EscharEx has demonstrated advantages over the leading enzymatic debridement agent and targets a substantial global market opportunity. Tillkännagivande • Apr 01
MediWound Ltd., Annual General Meeting, May 06, 2026 MediWound Ltd., Annual General Meeting, May 06, 2026. Location: offices of latham & watkins llp, conference center, 1271 avenue of the americas, new york,10020-1300., new york, United States Tillkännagivande • Mar 05
Mediwound Ltd. Reaffirms Revenue Guidance for the Year 2026, 2027 and 2028 MediWound Ltd. reaffirmed its revenue guidance for the year 2026, 2027 and 2028. For the year 2026, the company expect revenue of $24–26 million.
For the year 2027, the company expect revenue of $32–35 million.
For the year 2028, the company expect revenue of $50–55 million. Tillkännagivande • Feb 19
MediWound Ltd. to Report Q4, 2025 Results on Mar 05, 2026 MediWound Ltd. announced that they will report Q4, 2025 results on Mar 05, 2026 Tillkännagivande • Jan 13
Mediwound Ltd. Updates Revenue Guidance for the Fiscal Year 2026 , 2027, and 2028 MediWound Ltd. updated revenue guidance for the fiscal year 2026, 2027, and 2028. For the 2026, Updated revenue guidance projects $24–26 million.
For the 2027, updated revenue guidance projects $32–35 million.
For the 2028, updated revenue guidance projects $50–55 million. Tillkännagivande • Dec 11
MediWound Ltd. Reports New Clinical Data Demonstrating NexoBrid's Effectiveness in Preventing Traumatic Tattoos After Abrasion and Blast Injuries MediWound Ltd. announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid®? substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries. Traumatic tattoos occur when high-velocity accidents or blasts drive materials such as asphalt, dirt, glass, or metallic particles (shrapnel) into the skin, often leaving not only permanent dark discoloration but also causing aesthetic deformities, functional impairment, and increased risk of inflammation or infection. Current standard of care relies on aggressive non-selective mechanical scrubbing, which may leave embedded particles behind and may risk damage to viable tissue. NexoBrid development has been supported with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. Tillkännagivande • Nov 05
MediWound Ltd. to Report Q3, 2025 Results on Nov 20, 2025 MediWound Ltd. announced that they will report Q3, 2025 results on Nov 20, 2025 Tillkännagivande • Sep 30
MediWound Ltd. has filed a Follow-on Equity Offering in the amount of $30.000017 million. MediWound Ltd. has filed a Follow-on Equity Offering in the amount of $30.000017 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,734,105
Price\Range: $17.3
Discount Per Security: $1
Transaction Features: Registered Direct Offering Tillkännagivande • Sep 25
Mediwound Ltd. Expands Global Reach with Marketing Approval of Nexobrid®? in Australia MediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®?, the Company's innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns. With this approval, NexoBrid is now authorized in 45 countries worldwide, reflecting its growing recognition as a new standard of care in burn management. MediWound's exclusive partner in Australia, Balance Medical, expects to initiate commercial launch in the fourth quarter of 2025. MediWound's manufacturing expansion, on track for completion by year-end 2025, will support this launch and future global demand. Tillkännagivande • Aug 14
Mediwound Ltd. Announces New Escharex Phase Ii Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers MediWound Ltd. announced the publication of "The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the enzymatic therapies for non-surgical tissue repair, in Advances in Wound Care, a leading peer-reviewed journal focused on tissue injury and repair. The publication presents data demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs). The analysis includes data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive up to two weeks of daily treatments with either EscharEx, a placebo gel vehicle, or non-surgical standard of care, followed by standard dressings applied weekly for 12 weeks. WBP was defined as complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue. Key Findings: Wounds that failed to achieve WBP had a 90% probability of not healing (Negative Predictive Value = 90%) Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not (p = 0.0004); Early achievement of WBP (within 14 days) was associated with a significantly increased likelihood of healing (Relative Risk = 2.4, p =0.0005); Wounds that failed to reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (Hazard Ratio = 12, p < 0.0001). These findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure. The data further validates EscharEx's therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers. Dr. Marissa J. Carter, a clinical trial specialist and biostatistician focused on chronic wound care research, emphasized the broader implications of the results: "While wound bed preparation has long been accepted as the concept foundation for managing chronic wounds, this landmark analysis provides evidence, for the first time, that there is a strong correlation between the two. Importantly, the findings indicate a high negative predictive value associated with the lack of wound bed preparation. Tillkännagivande • Aug 04
MediWound Ltd. to Report Q2, 2025 Results on Aug 14, 2025 MediWound Ltd. announced that they will report Q2, 2025 results Pre-Market on Aug 14, 2025 Tillkännagivande • May 21
MediWound Ltd. Reaffirms Revenue Guidance for the Year 2025 MediWound Ltd. reaffirmed revenue guidance for the year 2025. For the full-year 2025 revenue guidance reaffirmed at $24 million. Tillkännagivande • May 14
MediWound Ltd. Announces Publication of Phase II EscharEx® Data Demonstrating Superiority over Collagenase in Venous Leg Ulcers MediWound Ltd. announced the publication of a peer-reviewed post hoc analysis in Wounds. The analysis is based on data from the Company's Phase II ChronEx clinical trial in patients with venous leg ulcers (VLUs) evaluating the efficacy and safety of EscharEx®? compared with Collagenase ointment (SANTYL®?), the only FDA-cleared enzymatic debridement agent commercially available for the treatment of dermal ulcers. The article, titled "Bromelain-Based Debridement Versus Collagenase Ointment Debridement Debridement Debridement of Venous Leg Ulcers: Post Hoc Analysis of the ChronEx Trial," appears in the April 2025 edition of Wounds (Index 2025;37(4):166-173) and compares outcomes in a subgroup of patients from the non-surgical standard of care arm treated with SANTYL (n=8) to those treated with EscharEx (n=46). EscharEx has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity. Tillkännagivande • May 05
MediWound Ltd. to Report Q1, 2025 Results on May 21, 2025 MediWound Ltd. announced that they will report Q1, 2025 results on May 21, 2025 Tillkännagivande • Apr 28
MediWound Ltd. to Present New EscharEx®? Data At Leading Wound Care Conferences MediWound Ltd. announced that it will present 10 scientific abstracts--including both oral and poster presentations-- at two of the world's premier wound care conferences: the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2025, taking place April 30-May 3 in Grapevine, Texas. The presentations will feature new preclinical and clinical data on EscharEx®?, MediWound's investigational enzymatic therapy for chronic wounds. The findings offer important insights into EscharEx's multitargeted and selective proteolytic activity on non-viable tissue. Results from a novel hard-to-heal wound model demonstrating EscharEx's superior debridement efficacy compared to collagenase SANTYL®? Symposium on Advanced Wound care (SAWC). Overview of EscharEx's mechanism of action, including in vitro studies and clinical findings from EscharEx and NexoBrid®? Case studies highlighting EscharEx's use in advanced DFUs (Wagner grade 2) and VLUs. Post-hoc analyses in DFUs and preliminary strategy for the planned clinical trial. Update on the VALUE Phase III study design and enrollment progress. The VALUE Phase III study is currently enrolling patients with VLUs across multiple sites, building on positive results from three completed Phase II studies that demonstrated EscharEx's efficacy, safety, and potential to enhance standard wound care practices. Tillkännagivande • Apr 08
MediWound Ltd., Annual General Meeting, May 15, 2025 MediWound Ltd., Annual General Meeting, May 15, 2025. Location: offices of latham & watkins llp, conference center, 1271 avenue of the americas, 10020-1300., new york United States Tillkännagivande • Mar 03
MediWound Ltd. to Report Q4, 2024 Results on Mar 19, 2025 MediWound Ltd. announced that they will report Q4, 2024 results on Mar 19, 2025 Tillkännagivande • Feb 26
MediWound Ltd. Announces Phase III CIDS Publication on NexoBrid for Pediatric Burn Care MediWound Ltd. announced the publication of its Phase III Children Innovative Debridement Study (CIDS) in Burns, the peer-reviewed Journal of the International Society for Burn Injuries (ISBI). The study evaluated the efficacy and safety of NexoBrid®? compared to the standard of care (SOC) in pediatric patients with deep partial- and full-thickness thermal burns. The publication, titled "Open-Label RCT of the Efficacy and Safety of NexoBrid Compared to SOC in Children with Burns," presents findings that supported the label expansion of NexoBrid for pediatric patients in the E.U. (2023) and U.S. (2024). These results reinforce NexoBrid's clinical benefits as a rapid, effective, and non-surgical alternative for eschar removal in pediatric burn patients, validating its significance as a transformative treatment in burn care. Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include 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. The Company specializes in the development, production and commercialization of innovative biologics that enhance existing standards of care and improve patient experiences while reducing healthcare costs and unnecessary surgeries. MediWound's first drug, NexoBrid®?, is an FDA- and EMA-approved orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burn, significantly reducing the need for surgical interventions. Leveraging its proprietary enzymatic technology, MediWound is advancing EscharEx®?, a promising candidate currently in Phase III development for the debridement of chronic wounds. Phase II clinical trials have shown EscharEx has distinct advantages over the currently available $375+ million drug for wound debridement, presenting a unique opportunity for significant market growth. Tillkännagivande • Feb 12
MediWound Initiates the VALUE Global Phase III Pivotal Trial of EscharEx® for Treatment of Venous Leg Ulcers MediWound Ltd. announced the initiation of VALUE, a global, pivotal Phase III trial evaluating EscharEx for the treatment of venous leg ulcers (VLUs). The VALUE study is a global, multicenter, prospective, randomized, double-blind, placebo-controlled trial with an adaptive design, that will be conducted across 40 sites in the U.S. and Europe. Its primary objective is to evaluate the efficacy and safety of EscharEx in achieving effective debridement and preparing the wound bed for healing in VLUs. The study will enroll 216 patients, randomized 1:1 to receive either EscharEx or placebo. Patients will undergo up to eight daily applications over two weeks, followed by ten weeks of standardized wound management. Patients achieving wound bed preparation—defined as complete debridement and full coverage with granulation tissue—will receive a cellular/tissue-based product (CTP) or an autograft. Those achieving complete wound closure will be monitored for an additional 12 weeks. The study co-primary endpoints are the incidence of complete debridement and the incidence of complete wound closure. Secondary endpoints include the incidence of complete granulation tissue, time to debridement, time to complete wound closure, and changes in wound area. Safety and tolerability of EscharEx will be assessed throughout the trial. An interim sample size assessment will occur after 65% of patients complete treatments, enabling adaptive adjustments as needed. This interim analysis is expected in mid-2026. To support the trial, MediWound has established strategic research collaborations with Solventum, Mölnlycke, and MIMEDX. These industry leaders will provide advanced products to ensure consistent wound management across all study sites and optimize patient outcomes. In addition to the VALUE study, MediWound plans to initiate a randomized, head-to-head Phase II study in 2025, comparing EscharEx to collagenase in VLU patients. This Phase II trial is designed to support the U.S. Biologics License Application (BLA) submission for EscharEx and strengthen MediWound’s commercialization strategy. Furthermore, the company is advancing preparations for an adaptive design Phase II/III clinical trial targeting diabetic foot ulcers (DFUs), which is expected to begin in 2026. Tillkännagivande • Nov 26
MediWound Ltd. Revises Revenue Guidance for 2024 MediWound Ltd. revised revenue guidance for 2024. The Company anticipates $20 million in total revenue for 2024, compared to prior guidance of $24 million. Tillkännagivande • Nov 12
MediWound Ltd. to Report Q3, 2024 Results on Nov 26, 2024 MediWound Ltd. announced that they will report Q3, 2024 results on Nov 26, 2024 Tillkännagivande • Oct 10
MediWound Ltd. Announces Phase II Head-To-Head Study Evaluating EscharEx®? vs. Collagenase in Patients with Venous Leg Ulcers MediWound Ltd. announced that it will be initiating a controlled, multicenter Phase II clinical study evaluating EscharEx® against collagenase ointment (marketed as SANTYL® in the U.S. and IRUXOL® in Europe) for the treatment of venous leg ulcers (VLUs). Scheduled to commence in 2025, this Phase II study will run concurrently with the Company’s Phase III trial in VLU patients. The study is designed to support the Biologics License Application (BLA) for EscharEx and plays a key role in MediWound’s commercialization strategy. The randomized, prospective study will enroll 45 patients across multiple sites in the U.S. and Europe. VLU patients will be randomly assigned in a 1:1:1 ratio to receive either EscharEx, placebo, or collagenase. In the first two weeks, the EscharEx and placebo groups will receive up to 8 daily applications, while the collagenase group will follow the product’s instructions for use (IFU). Each patient’s participation will last up to 14 weeks. Key safety endpoints, including the incidence and severity of adverse events (AEs), and time to complete wound closure, will be assessed. Additionally, exploratory efficacy endpoints will evaluate the incidence and time to complete debridement, granulation tissue formation, and wound bed preparation. To support this trial, MediWound has formed additional strategic R&D collaborations with Solventum and Mölnlycke Health Care. Solventum will supply the Coban™ 2 Two-Layer Compression System, while Mölnlycke will provide Mepilex®, Mepilex® Ag, Exufiber®, and Exufiber® Ag. These partnerships are designed to enhance consistency across study arms and ensure the use of best-in-class products, ultimately benefiting patient outcomes. Reported Earnings • Aug 15
Second quarter 2024 earnings released: US$0.68 loss per share (vs US$0.099 profit in 2Q 2023) Second quarter 2024 results: US$0.68 loss per share (down from US$0.099 profit in 2Q 2023). Revenue: US$5.06m (up 6.1% from 2Q 2023). Net loss: US$6.31m (down US$7.22m from profit in 2Q 2023). Revenue is forecast to grow 38% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 25% per year but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings. Tillkännagivande • Aug 06
MediWound Ltd. Announces Positive Results from the U.S. NexoBrid Expanded Access Protocol (NEXT) MediWound Ltd. announced the positive results of the NEXT--an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated the accumulation of real-world safety and clinical data for NexoBrid. NEXT, an open-label, single-arm treatment protocol was conducted at 29 burn centers across the U.S. 239 patients, including 215 adults and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of the total body surface area (TBSA) were treated with NexoBrid. Key Results of the NEXT Protocol Include: Efficacy (findings were consistent with Phase III studies results): 94.9% of adults and 100% of children achieved complete debridement. Only 4.2% of adults required surgical excision for eschar removal after NexoBrid treatment, and none in the pediatric group. The mean (± SD) percent of wound area surgically excised for adults was 3.6% (±18.33), and 0% for children. The time to complete eschar removal was less than one day for both adults and children. Healing and Hospitalization: The median time to wound closure was 22 days (95% CI: 22, 23) for adults and 28 days (95% CI: 18, 32) for children. The median time of hospitalization duration was 10 days (95% CI: 8, 11) for adults and 10 days (95% CI: 5, 14) for children. Safety: The safety data was consistent with the established safety profile of NexoBrid, and no new safety concerns were identified by the Data Safety and Monitoring Board (DSMB). Benefit-Risk Ratio: The overall benefit-to-risk ratio of NexoBrid treatment remains favorable. NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid is approved in over 40 countries, including the United States, European Union, and Japan. It has been designated as an orphan biologic drug in all these territories. NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include 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. Tillkännagivande • Aug 02
MediWound Ltd. to Report Q2, 2024 Results on Aug 14, 2024 MediWound Ltd. announced that they will report Q2, 2024 results on Aug 14, 2024 Tillkännagivande • Jul 29
MediWound Ltd. Announces Publication of the EscharEx® Phase II ChronEx Study Results for Venous Leg Ulcers MediWound Ltd. announced the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eClinicalMedicine, a journal under THE LANCET Discovery Science umbrella. The publication, titled "Once daily Bromelain-based enzymatic debridement of venous leg ulcers versus gel vehicle (placebo) and non-surgical standard of care: a three-arm multicenter, double-blinded, randomized controlled study", reports the results of the study. The Phase II ChronEx study was conducted across 20 medical centers and clinics in the United States, Europe and Israel. Patients were randomized in a 3:3:2 ratio to receive daily treatment with EscharEx, a Gel Vehicle (placebo), or non-surgical standard of care (NSSOC), which included SANTYL®, hydrogels, medical grade honey, and non-active dressings. Treatment lasted for up to two weeks (with a maximum of eight daily applications) or until complete debridement was achieved. Following treatment, patients were monitored weekly for an additional 12 weeks. Key study outcomes include: A total of 119 patients were randomized and treated: 46 in the EscharEx arm, 43 in the placebo arm, and 30 in the NSSOC arm. Baseline characteristics of patients and wounds were comparable across all study arms. The study met its primary endpoint: the incidence of complete debridement during the two-week daily treatment was 63.0% for EscharEx compared to 30.2% for placebo (P = 0.004). The incidence of complete debridement for NSSOC during the daily treatment period was 13.3% (P < 0.001). The median time to complete debridement was 9 days for EscharEx vs. 63 days for placebo (P = 0.004) and 59 days for NSSOC (P = 0.016). The incidence of complete cover of the wound bed with healthy granulation tissue during the daily treatment period, was 50.0% for EscharEx compared to 25.6% for placebo (P = 0.01) and 10.0% for NSSOC (P < 0.001). Changes in patient-reported pain, wound size, or wound quality of life (QoL) were comparable between the three treatment arms. The safety profile of EscharEx was comparable to both NSSOC and the placebo. Tillkännagivande • Jul 16
MediWound Ltd. announced that it expects to receive $24.999994 million in funding from Mölnlycke Health Care AB and other investors MediWound Ltd. announced that it has entered into a share purchase agreement with with several new and existing investors, including Mölnlycke Health Care ("Mölnlycke") to issue 1,453,488 common shares at an issue price of $17.20 per share for the gross proceeds of $24,999,993.6 on July 15, 2024. The Private Placement is being effected pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”) contained in Section 4(a)(2) of and/or Regulation D under the Securities Act. Concurrently with the PIPE Offering, MediWound and Mölnlycke entered into a collaboration agreement to strengthen their partnership. The Collaboration Agreement also contains a stand-still clause that limits Mölnlycke's ownership to no more than 9.99% of the Company's issued and outstanding Ordinary Shares.. The PIPE Offering is expected to close within several days, subject to satisfaction of customary closing conditions. New Risk • Jun 03
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$13m Forecast net loss in 3 years: US$1.2m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (11% average weekly change). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$1.2m net loss in 3 years). Tillkännagivande • May 31
MediWound Ltd., Annual General Meeting, Jul 09, 2024 MediWound Ltd., Annual General Meeting, Jul 09, 2024. Location: at the offices of latham & watkins llp, conference center, 1271 avenue of the americas, new york 10020-1300, new york United States Reported Earnings • May 30
First quarter 2024 earnings released: US$1.05 loss per share (vs US$0.44 loss in 1Q 2023) First quarter 2024 results: US$1.05 loss per share (further deteriorated from US$0.44 loss in 1Q 2023). Revenue: US$4.96m (up 31% from 1Q 2023). Net loss: US$9.73m (loss widened 163% from 1Q 2023). Revenue is forecast to grow 38% p.a. on average during the next 3 years, compared to a 3.9% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 5% per year, which means it is significantly lagging earnings. Tillkännagivande • May 24
MediWound Ltd. to Report Q1, 2024 Results on May 29, 2024 MediWound Ltd. announced that they will report Q1, 2024 results on May 29, 2024 New Risk • Apr 17
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 11% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. This is currently the only risk that has been identified for the company. Reported Earnings • Mar 21
Full year 2023 earnings released: US$0.74 loss per share (vs US$3.93 loss in FY 2022) Full year 2023 results: US$0.74 loss per share (improved from US$3.93 loss in FY 2022). Revenue: US$18.7m (down 30% from FY 2022). Net loss: US$6.72m (loss narrowed 66% from FY 2022). Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 20% per year, which means it is significantly lagging earnings. Tillkännagivande • Mar 15
MediWound Ltd. to Report Q4, 2023 Results on Mar 21, 2024 MediWound Ltd. announced that they will report Q4, 2023 results on Mar 21, 2024 Tillkännagivande • Feb 13
Mediwound Ltd. Announces Positive Results in Head-To-Head Comparison of Escharex® Vs. Santyl® Within the Chronex Phase Ii Randomized Controlled Study MediWound Ltd. announced the results of head-to-head comparison analyses of EscharEx, the Company’s lead asset in development for chronic wounds, to collagenase SANTYL ointment, approved by the FDA for debriding chronic dermal ulcers. SANTYL is currently the market-leading enzymatic debridement product, with more than $360 million in estimated annual sales in the United States. Results from the previously disclosed Phase II study (ChronEx) which evaluated the safety and efficacy of EscharEx, demonstrated the superiority of EscahrEx vs. a gel vehicle (placebo) and non-surgical standard of care (NSSOC), in achieving complete debridement of non-viable tissue and promotion of granulation tissue (healthy, highly vascularized tissue). The secondary analyses announced assessed the incidence and time to complete debridement, complete granulation, and wound closure in patients treated with EscharEx (n=46) compared to a sub-group of patients who were treated with SANTYL (n=8). Tillkännagivande • Jan 10
Mediwound Announces That FDA Has Accepted for Review the Supplement to the Nexobrid BLA to Include Pediatric Patients with Severe Thermal Burns MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has completed their filing review and accepted a supplement to the NexoBrid® biologics license application (sBLA) for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns. NexoBrid, a topically administered biological drug that enzymatically removes nonviable burn tissue, received FDA approval in the U.S. in December 2022 for eschar removal in adult patients with deep partial-thickness and/or full-thickness thermal burns. The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages. It is based on the results of a global Phase 3 clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. Of note, the CIDS trial was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. Tillkännagivande • Dec 22
Mediwound Ltd. Announces Publication of Escharex Mechanism of Action Study Assessing Its Effects on Biofilm and Microbial Loads MediWound Ltd. announced the publication of a peer-reviewed paper, titled "An Open-label, Proof of Concept Study, Assessing the Effects of Bromelain-Based Enzymatic Debridement on Biofilm and Microbial Loads in Patients with Venous Leg and Diabetic Foot Ulcers" in the December 2023 issue of WOUNDS Journal. The paper highlights results from a Phase II study, which explored the mechanism of action of EscharEx, a novel Bromelain based enzymatic debridement agent, in 12 patients with either venous leg ulcers (VLUs) or diabetic foot ulcers (DFUs). Results show that EscharEx not only effectively debrides wounds, but also reduces biofilm and bacterial load in both VLUs and DFUs. Key findings: 70% of the patients (7/10) that completed the study achieved complete debridement within a median time of 5.5 days. An average reduction of 35% in wound size was achieved by the end of the 2-week follow-up period. Together with the outcomes of previous Phase II study results, this study furthers the understanding of the effects of EscharEx. It demonstrates its effectiveness not only in enzymatic debridement and promotion of granulation tissue, but potentially also in reducing biofilm and bacterial load. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries. MediWound's first drug, NexoBrid®?, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company's lead drug under development, EscharEx®?. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound's pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study. Reported Earnings • Nov 24
Third quarter 2023 earnings released: US$0.24 loss per share (vs US$0.88 loss in 3Q 2022) Third quarter 2023 results: US$0.24 loss per share (improved from US$0.88 loss in 3Q 2022). Revenue: US$4.78m (down 18% from 3Q 2022). Net loss: US$2.20m (loss narrowed 48% from 3Q 2022). Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 28% per year, which means it is significantly lagging earnings. Tillkännagivande • Nov 22
MediWound Ltd. Appoints Shmulik Hess as Chief Operating Officer and Chief Commercial Officer, Effective December 1, 2023 MediWound Ltd. announced the appointment of Shmulik Hess, Ph.D. to the positions of Chief Operating Officer and Chief Commercial Officer effective as of December 1, 2023. Dr. Hess will lead and oversee all operational and commercial activities at MediWound. Dr. Hess has over two decades of extensive expertise in drug development and commercial operations in healthcare. He possesses a wealth of leadership experience in operational strategies, sales, and commercial facets within the global biopharma industry. Prior to joining MediWound, he served as Chief Executive Officer at Tabby Therapeutics, Enlivex Therapeutics and Valin Technologies. Formerly, Dr. Hess served as a global operations executive at SciGen Ltd. Dr. Hess is the inventor of multiple patents and author of numerous publications in peer reviewed scientific journals. He received his Ph.D. in Pharmaceutical Science from the Hebrew University, Israel and was a research fellow at Harvard-MIT Health Sciences and Technology (HST). Tillkännagivande • Nov 15
MediWound Ltd. to Report Q3, 2023 Results on Nov 21, 2023 MediWound Ltd. announced that they will report Q3, 2023 results at 9:30 AM, US Eastern Standard Time on Nov 21, 2023 Tillkännagivande • Nov 14
MediWound Ltd Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric Patients MediWound Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently. This positive opinion is based on the results of a global Phase 3 trial that evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients (CIDS study), funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. It is also supported by additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. The Phase 3 study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in the time to achieve complete eschar removal and a significant reduction in the wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars as measured by MVSS. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and a reduction in the need for autograft in deep partial burns, as well as a favorable trend in the reduction of blood loss during the eschar removal process. In addition, the study confirmed NexoBrid to be safe and well-tolerated for all ages. Tillkännagivande • Sep 27
MediWound Ltd. Secures Additional U.S. Department of Defense Funding to Advance NexoBrid Development for the U.S. Army MediWound Ltd. announced that the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), has awarded MediWound additional funding to develop NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army (the "MTEC Research Project Award"). The $6.5 million project budget will advance the development of a new, temperature stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings. The MTEC Research Project Award was granted by the DoD’s U.S. Army Medical Research and Development Command (USAMRDC) and funded by the Defense Health Agency through MTEC, a biomedical technology consortium working to advance innovative medical solutions to keep military personnel healthy and fully operational. In alignment with this mission, it's vital to have field solutions for severe burn treatments that are both easy-to-use and effective. Such solutions should be applicable immediately post-injury and demand minimal preparation and training. Tillkännagivande • Sep 22
MediWound Ltd. Announces U.S. Commercial Availability of NexoBrid®? for the Treatment of Severe Thermal Burns in Adults MediWound Ltd. announced the U.S. commercial availability of NexoBrid®? (anacaulase-bcdb) for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns. Eschar removal is a critical first step in the treatment of burns as it can reduce inflammation, stop burn progression, as well as mitigate infections and sepsis. Surgical excision, which is the current standard of care for eschar removal, often results in the removal of viable tissue. NexoBrid selectively targets eschar while preserving viable tissue, enabling more rapid and precise eschar removal, which may reduce the need for subsequent skin grafting and lessen patient trauma. Each year, approximately 40,000 people are hospitalized in the U.S. for burn-related injuries, and of those patients, more than 30,000 of them require some level of eschar removal, representing a $300 million addressable market for NexoBrid in the U.S. NexoBrid can be applied in up to two applications of four hours each. Board Change • Sep 01
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 3 experienced directors. No highly experienced directors. Independent Director Vickie Driver is the most experienced director on the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. New Risk • Aug 23
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (53% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$6.1m net loss in 3 years). Share price has been volatile over the past 3 months (6.5% average weekly change). Market cap is less than US$100m (€60.5m market cap, or US$65.7m). Reported Earnings • Aug 18
Second quarter 2023 earnings released: EPS: US$0.099 (vs US$0.92 loss in 2Q 2022) Second quarter 2023 results: EPS: US$0.099 (up from US$0.92 loss in 2Q 2022). Revenue: US$4.77m (up 2.2% from 2Q 2022). Net income: US$916.0k (up US$5.27m from 2Q 2022). Profit margin: 19% (up from net loss in 2Q 2022). The move to profitability was primarily driven by lower expenses. Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 3.2% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 24% per year, which means it is performing significantly worse than earnings. Tillkännagivande • Aug 08
MediWound Ltd. to Report Q2, 2023 Results on Aug 15, 2023 MediWound Ltd. announced that they will report Q2, 2023 results on Aug 15, 2023 Tillkännagivande • Aug 03
MediWound Ltd. Announces Commercial Launch of NexoBrid®? in Japan MediWound Ltd. announced that its strategic partner, Kaken Pharmaceutical Co. Ltd, launched NexoBrid®? in Japan for the treatment of deep partial thickness and full thickness burns in adults and pediatric patients. Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive marketing and distribution rights for NexoBrid in Japan. NexoBrid is indicated for the removal of eschar in deep partial and full thickness thermal burns. The prospects are excellent for it becoming the new standard-of-care for serious and life-threatening burns, bringing significant benefits to providers and patients alike. Given long-term relationship with MediWound, have been anticipating this moment. NexoBrid is approved in over 40 countries, including in the United States and in the European Union where it has been designated as an orphan biologic drug. Development of NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA). The pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30% of total body surface area met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and less blood loss during eschar removal. Tillkännagivande • Jul 11
Mediwound Ltd. Announces Positive Results in Its U.S. Phase I/Ii Study of Mw005 for the Treatment of Basal Cell Carcinoma MediWound Ltd. announced positive data from its Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data show MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions. The Phase I/II study is an open-label, multi-centered, randomized clinical trial designed to evaluate the safety and efficacyof MW005 in patients with BCC. All of the patients enrolled in the study had histologically confirmed superficial or nodular BCC. Enrolled patients received seven topical applications of MW005 once every other day for fourteen days. Eight weeks following the last treatment, all patients underwent a complete precisional biopsy. The excised specimen was subjected to an independent histological clearance examination. The study’s endpoints include safety and tolerability measurements, as well as efficacy assessments, as measured by the proportion of patients who reach clinically and histologically confirmed complete clearance. Fifteen patients were treated with MW005 and completed the study. Results showed MW005 to be safe and well-tolerated, with a high level of patient compliance. While the primary focus of the trial was on safety and tolerability, it is worth noting that based on clinical assessments, eleven out of fifteen patients achieved complete clearance of their BCCs; the majority of these patients also had histologically confirmed complete clearance. Data comprising clinical and histological outcomes, supported by extensive patient follow-up, will be featured at an upcoming scientific conference in 2023.These results corroborate the previous proof-of-concept study published by Prof. Rosenberg et al (Basal CellCarcinoma Destruction by a Concentrate of Proteolytic Enzymes Enriched in Bromelain: A Preliminary Report;TODJ-15-39 [1], 2021), where seven BCC tumors treated with MW005 were completely removed based on clinicalassessment, and none reoccurred over the subsequent 24 months. Tillkännagivande • Jul 04
MediWound Receives Positive Scientific Advice from European Medicine Agency (EMA) on EscharEx Phase III Study Design MediWound Ltd. announced it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) related to the development plan for the company’s Phase III study of EscharEx in the treatment of Venous Leg Ulcers (VLUs) and to the overall data required for subsequent potential marketing authorization submission and commercialization. The CHMP notified the company that it concurs with the overall design of the proposed study, including its objectives, choice of study arms, patient population, inclusion/exclusion criteria, standardization of treatment, proposed primary, secondary, and safety endpoints and study duration. Additionally, the CHMP indicated that it can accept one confirmatory study in VLU patients as the basis for approval, assuming the data are robust and similar to the company’s previous studies. In this initial indication for EscharEx, VLUs affect approximately 560,000 patients annually with an estimated $1 Billion market in the U.S. alone. The Phase III study will be a global, multi-center, prospective, randomized, placebo-controlled trial in approximately 244 patients, who will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications lasting 24 hours each. Patients will then be followed weekly for up to 10 weeks, during which time they will be treated with standard of care (SOC). Patients who achieve wound closure confirmation will continue for an additional 10-week follow-up. The co-primary endpoints are the incidence of complete debridement at the end of the daily visit period, and time to achieve wound closure. EscharEx uses the same active pharmaceutical ingredient (API) as the NexoBrid®, which has been approved for debridement of thermal burns in the U.S. and Europe. Reported Earnings • May 31
First quarter 2023 earnings released: US$0.44 loss per share (vs US$0.87 loss in 1Q 2022) First quarter 2023 results: US$0.44 loss per share. Revenue: US$3.80m (down 14% from 1Q 2022). Net loss: US$3.69m (loss widened 2.9% from 1Q 2022). Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Tillkännagivande • May 13
MediWound Ltd. to Report Q1, 2023 Results on May 30, 2023 MediWound Ltd. announced that they will report Q1, 2023 results on May 30, 2023 Reported Earnings • Mar 17
Full year 2022 earnings released: US$3.93 loss per share (vs US$3.48 loss in FY 2021) Full year 2022 results: US$3.93 loss per share (further deteriorated from US$3.48 loss in FY 2021). Revenue: US$26.5m (up 12% from FY 2021). Net loss: US$19.6m (loss widened 45% from FY 2021). Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 45% per year but the company’s share price has only fallen by 2% per year, which means it has not declined as severely as earnings. Tillkännagivande • Dec 30
MediWound Ltd. Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. NexoBrid is already approved for use in 43 countries, including the European Union, Japan, India, and other international markets. The BLA submission leading to FDA approval covered by a comprehensive battery of pre-clinical studies and 8 clinical studies, including the pivotal Phase 3 U.S. clinical study (DETECT), which evaluated the efficacy and safety of NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns of 3%-30% of total body surface area (TBSA). The study met its primary endpoint of incidence of =95% eschar removal compared to gel vehicle, as well as all secondary endpoints, including shorter time to eschar removal, lower incidence of surgical eschar removal and lower blood loss compared to surgical and non-surgical standard of care (SOC), including both surgical and non-surgical eschar removal methods, with highly statistically significant results. A safety endpoint of non-inferiority in time to >95% wound closure compared with patients treated with SOC was also achieved. In addition, non-inferiority was established between NexoBrid and SOC in cosmesis and function of burn scars after 12- and 24-month follow-up. Overall, NexoBrid is safe and well tolerated. NexoBrid can be applied in up to two applications of four hours each. A first application of NexoBrid may be applied to an area of up to 15% body surface area. A second application of NexoBrid may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA. Tillkännagivande • Dec 20
MediWound Announces Positive Results in U.S. Phase I/II Study of Mw005 for the Treatment of Basal Cell Carcinoma MediWound Ltd. announced positive data from its Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low- risk Basal Cell Carcinoma (BCC). The data shows MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions. MW005 contains the same active pharmaceutical ingredient as in NexoBrid(R) and EscharEx(R) . The results of this study represent further demonstration of the efficacy of MediWound's core enzymatic platform technology across various indications. Based on these positive results, MediWound plans to continue enrolling patients in its Phase I/II study, optimizing its dosing regimen and application technique. The results are expected in 2023. The Phase I/II study is an open-label, multicenter, randomized clinical trial designed to evaluate the safety and efficacy of MW005 in patients with BCC, using different regimens. All patients enrolled in the study must have histologically confirmed superficial or nodular BCC. Enrolled patients receive seven topical applications of MW005 once every other day for 14 days. Eight weeks after the last treatment, all patients undergo a complete excisional biopsy, and the specimen is subject to an independent histological clearance examination. The study's endpoints include safety and tolerability measurements, as well as efficacy assessment, as measured by the proportion of patients who reach clinically and histologically confirmed complete clearance. Eleven patients with either superficial or nodular histologically diagnosed BCC lesions were treated and completed the study. Based on the data generated, MW005 was shown to be safe, well-tolerated, and an effective treatment for BCC with patients demonstrating complete clinical and histological clearance of target lesions. Tillkännagivande • Dec 14
MediWound Ltd Gains Marketing Approval of NexoBrid® in India MediWound Ltd. announced it has gained marketing approval of NexoBrid® in India. MediWound has signed an agreement granting Bharat Serums and Vaccines Limited (BSV), a leading biopharmaceutical company in India, the exclusive right to market and distribute NexoBrid in India for the treatment of severe burns. BSV is expected to begin commercializing NexoBrid in India in the first half of 2023. Board Change • Nov 16
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Sam Moed was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Nov 04
MediWound Ltd. to Report Q3, 2022 Results on Nov 15, 2022 MediWound Ltd. announced that they will report Q3, 2022 results on Nov 15, 2022 Board Change • Nov 02
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Sam Moed was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Oct 26
MediWound Ltd. Announces Formation of Strategic Advisory Board MediWound Ltd. announced the establishment of a Strategic Advisory Board (SAB). The inaugural members of the MediWound SAB represent a diverse group of experienced executives who bring a depth and breadth of strategic insight to guide the Company. The inaugural members of the MediWound SAB include: John C. Lantis, MD, Chief of Surgery at Mount Sinai West Hospital in New York, practices as a senior vascular surgeon. He holds the academic title of Professor of Surgery at the Icahn School of Medicine. He is a world leader in limb salvage and lower extremity wound healing. To date, he has been the principal investigator on over 70 clinical trials. He directs a clinical research program in the field of lower extremity wound healing and tissue repair and published extensively. He currently sits on the editorial board of WOUNDS and is a reviewer for other journals. Dr. Lantis will provide MediWound with his medical expertise in all aspects of wound care. Samuel Moed, Venture Partner at aMoon, Israel’s larger HealthTech VC fund. Mr. Moed has recently retired from Bristol Myers Squibb (BMS), as Senior Vice President, Corporate Strategy. He led the strategic direction of the company with close linkage to all its major businesses, functions, and geographies. His recent focus was on the $90 billion acquisition and integration of Celgene by BMS. He serves in Board and advisory roles supporting companies in the HealthTech sector. Mr. Moed with his experience as an executive in the life sciences industry will provide MediWound with his expertise in strategic development for life science innovations. Eric Shem-Tov, Co-founder and CEO of Equashield, a leading global provider of hazardous drug compounding technologies. Recently collaborated with Nordic Capital in a deal valued at $1.3 billion. He also founded Biopharmax, a global design and construction provider of manufacturing facilities and systems for biotechnology, pharmaceutical and synthesis API manufacturers. Mr. Shem-Tov will provide MediWound with his expertise in scaling up facilities and optimizing manufacturing processes. Tillkännagivande • Oct 20
MediWound's EscharEx® Featured in Oral and Poster Presentations at the Symposium on Advanced Wound Care (SAWC) Fall 2022 MediWound Ltd. announced that positive clinical data from the Company’s EscharEx® Phase 2 trials was featured in an oral and two poster presentations at the Symposium on Advanced Wound Care (SAWC) Fall 2022 Conference in Las Vegas, Nevada. The abstract poster chosen for oral presentation was one of four posters selected out of 290 abstracts presented. In the oral presentation, John C. Lantis II, MD, Chief of Surgery at New York’s Mount Sinai West Hospital, presented updated results from the EscharEx Phase 2 study (Chronex): “A Phase 2 multicenter, prospective, randomized, placebo controlled, adaptive design study performed to evaluate the safety and efficacy of Bromelain-based enzymatic debridement agent in debridement of Venous Leg Ulcers”. The data demonstrated EscharEx to be significantly better than gel vehicle and the non-surgical standard of care across multiple measures including incidence of complete debridement, time to achieve complete debridement and granulation tissue formation. There were no deleterious effects on wound closure, and overall, the product was safe and well tolerated. The EscharEx Phase 2 study results were also highlighted in a poster presented by Dr. Cyaandi R. Dove, DPM, Advanced Wound & Ankle Center, Las Vegas. Dr. Robert J. Snyder, DPM, MSc, Chief Medical Director of EscharEx program, presented the second poster: “Updated Results from an Open Phase 2 Study Assessing the Safety, Efficacy and Pharmacological Effects of Bromelain-based Enzymatic Debridement Product on Biofilm and Microbial loads in patients with DFU and VLU”, which highlighted data from the Phase 2 pharmacology study (Pharmex) completed in 2022. Results from this study showed EscharEx to be safe, rapid, and highly effective in debridement of VLUs and DFUs. The data also demonstrated that EscharEx reduces wound size, biofilm, and bacterial burden. The Symposium on Advanced Wound Care (SAWC) Fall is the official meeting of the Wound Healing Society and is the world’s most comprehensive event of the year featuring scientific abstracts covering the most critical topics in wound care. The SAWC Fall serves as a forum to connect the entire wound care team of physicians (DO, DPM, MD), nurses, physical therapists, researchers, scientists, and dietitians, with the foremost experts in wound care in order to improve patient outcomes through education. Tillkännagivande • Sep 21
MediWound Ltd. Announces European Medicines Agency Validates for Review the Type Ii Variation MediWound Ltd. announced that the European Medicines Agency has validated for review the Type II Variation submitted by MediWound in order to expand the current approved indication for NexoBrid into the pediatric population. MediWound expects a decision from the European Commission in the first quarter of 2023. EMA has initiated evaluation of the application to extend the use of NexoBrid to children aged newborn through eighteen. The submission is supported by the interim results of a global, Phase 3 trial, evaluating the safety and efficacy of NexoBrid in hospitalized pediatric patients, and by additional data available from children who participated in the EU phase 3 study (MW2004-11-02) and phase 2 studies conducted during the clinical development of NexoBrid. In July 2021, MediWound announced the results from the CIDS trial, a Phase 3, multinational, randomized, multicenter, open label, controlled, 2 arm study performed in children with deep partial thickness and full thickness thermal burns of 1% to 30% of total body surface area. Top line Results demonstrated that the CIDS study successfully met its primary endpoint and secondary endpoints with a comparable safety profile to the standard of care. NexoBrid safety profile in children is consistent with the safety profile in adults. Patients’ follow-up is on-going. NexoBrid development has been supported with federal funding from U.S. Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services under ongoing contract numbers HHSO100201500035C and HHSO100201800023C. Contract number HHSO100201500035C provides funding and technical support for the pivotal U.S. Phase 3 clinical study and the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol in the U.S. Additional projects for evaluation of NexoBrid funded under the BARDA contract include the randomized, controlled pivotal clinical trial for use in the pediatric 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. Reported Earnings • Aug 11
Second quarter 2022 earnings released: US$0.13 loss per share (vs US$0.12 loss in 2Q 2021) Second quarter 2022 results: US$0.13 loss per share (down from US$0.12 loss in 2Q 2021). Revenue: US$4.67m (down 23% from 2Q 2021). Net loss: US$4.35m (loss widened 36% from 2Q 2021). Over the next year, revenue is forecast to grow 13%, compared to a 6.2% growth forecast for the industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 68 percentage points per year, which is a significant difference in performance. Tillkännagivande • Aug 10
Mediwound Ltd. Announces Management Changes MediWound Ltd. announced the appointments of Mr. Nachum (Homi) Shamir as the Chairman of the Company’s Board of Directors and Dr. Robert Snyder as the Company’s Chief Medical Officer. Mr. Shamir assumes the role of Chairman from Mr. Stephen T. Wills, who will remain on the Board as a Director. Dr. Snyder will assume his role as Chief Medical Officer on January 1, 2023. Professor Lior Rosenberg, founder and current Chief Medical Technology Officer, will continue to support the Company as a Medical Director focusing on the burn space and product life cycle management. Mr. Nachum Shamir joins as Chairman of the MediWound Board with a proven track record of bringing game-changing technologies to the market. He most recently served as Chairman, President, CEO of Luminex Corporation (LMNX) prior to its acquisition in 2021 by DiaSorin for $1.8 billion. Mr. Shamir was President and CEO at Given Imaging (GIVN) from 2006 until its acquisition in 2014 by Covidien PLC (now Medtronic) for $1 billion. Prior to that, he was Corporate Vice President of Eastman Kodak and President of Eastman Kodak Transaction and Industrial Solutions Group. Mr. Shamir joined Eastman Kodak from Scitex Corporation where he held various executive positions, including President and CEO, prior to its acquisition in 2004 by Eastman Kodak for $262 million. Mr. Shamir has held senior management positions at various international companies, mainly in the Asia Pacific regions. He currently is a Board Member at Strata Skin Sciences (SSKN) and Chairman at Cactus Acquisition Corp. (CCTS). His previous Board appointments include Cogentix Medical (CGNT), which was acquired in 2018 by Laborie Medical Technologies for $214 million, and Invendo Medical GmbH, which was acquired in 2017 by Ambu for €225 million. Mr. Shamir holds a Bachelor of Science from the Hebrew University of Jerusalem and a Masters of Public Administration from Harvard University. Dr. Robert J. Snyder (DPM, MSc, MBA, CWSP, FFPM RCPS) is Dean, Professor, 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. Dr. Snyder has completed an MBA in Health Management from The George Washington University and the Global Clinical Scholars Research Training Program at Harvard Medical School. Dr. Snyder is a key opinion leader and sought-after speaker, lecturing extensively throughout the United States and abroad. He has published several book chapters and over 165 papers in peer reviewed and trade journals on wound care, and was the recipient of the Dr. Robert Warriner Memorial Award for excellence in wound management. Dr. Snyder serves as the Associate Editor for JAPMA and on the editorial advisory boards of Ostomy Wound Management, Wounds and as a periodic reviewer for the Lancet and NEJM. He has been a Principal Investigator on more than 65 randomized controlled trials for innovative wound healing modalities and products. Tillkännagivande • Aug 04
MediWound Announces U.S. FDA Acceptance of Biologics License Application for Nexobrid for the Treatment of Severe Thermal Burns MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently re-submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of January 1, 2023. The BLA re-submission adds to the set of manufacturing data, preclinical and clinical studies previously submitted. These include extensive scrutiny of the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints with a comparable safety profile to the standard of care. NexoBrid is approved in the European Union and other international markets. It has been designated as an orphan biologic drug in the United States, European Union, and other international markets. NexoBrid is currently an investigational product in the United States. Vericel Corporation holds an exclusive license for North American commercial rights to NexoBrid. Tillkännagivande • Aug 02
MediWound Ltd. to Report Q2, 2022 Results on Aug 09, 2022 MediWound Ltd. announced that they will report Q2, 2022 results on Aug 09, 2022 Tillkännagivande • Jul 08
MediWound Ltd. Announces Positive Results from Its U.S. Phase 2 Pharmacology Study of EscharEx for Debridement of Lower Leg Ulcers MediWound Ltd. announced positive results from its U.S. prospective, open-label, single-arm, Phase 2 pharmacology clinical study of EscharEx® for the debridement of lower leg ulcers. The study was designed to evaluate the clinical performance, safety and pharmacology effect of EscharEx in debridement of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). 70% of patients achieved complete debridement during the course of treatment within up to 8 applications. On average, complete debridement was achieved after 3.9 applications of EscharEx. Additionally, an average reduction of 35% in wound size was achieved by the end of the 2-week follow-up period. In all patients that were positive for biofilm at baseline, the biofilm was reduced substantially to single individual microorganisms or completely removed by the end of treatment. Seven patients had positive red fluorescence (indicative of bacteria) at baseline and average red fluorescence was reduced from 1.69 cm2 pre-treatment to 0.60 cm2 post treatment. Biomarker analysis from wound fluid is on-going and safety data shows that EscharEx is safe and well-tolerated. The U.S. phase 2 pharmacology study was a prospective, open label, single-arm study, being conducted at three U.S. clinical sites. The study evaluated the clinical performance, safety, and pharmacology effect of EscharEx in the debridement of lower leg ulcers (VLUs and DFUs). The study evaluated the safety and efficacy of debridement as measured by incidence of, and time to complete debridement. In addition, the study evaluated the pharmacological effects of EscharEx as measured by the changes from baseline to end of treatment period in (1) wound biofilm presence in wound biopsies, (2) bacterial burden measured by MolecuLight® fluorescence images, and (3) biomarkers of wound healing and inflammation in wound fluid. Twelve patients with either DFUs or VLUs were enrolled in the study. Patients were treated with up to eight daily applications of EscharEx and then continued follow-up for 2 weeks. Punch biopsies and wound fluids were collected prior to the first, and after the last treatment. Biofilm presence was analyzed from wound biopsies. Wound fluids were analyzed to evaluate biomarkers of wound healing and inflammation, i.e., MMPs, cytokines, chemokines, growth factors and HNE. Fluorescent imaging was used during treatment to measure wound size and bacterial load. Fluorescent imaging was also utilized to identify the highest fluorescence area to obtain the biopsy. EscharEx demonstrated safe and effective debridement with a few daily applications. In addition, evaluation of wounds’ tissue samples (biopsies) and fluorescence images, indicated reduction of wound area, biofilm and bacterial bioburden following the treatment with EscharEx. Tillkännagivande • Jul 01
MediWound Ltd. Announces Appointment of Tzvi Palash as Chief Operating Officer MediWound Ltd. announced the appointment of Mr. Tzvi Palash as Chief Operating Officer (COO). Mr. Palash will be responsible for leading all operational activities at MediWound. Mr. Tzvi Palash brings over 35 years of experience with notable expertise in commercial operations in the healthcare industry. He joins MediWound from Enlivex, where he leads the design and construction of the new cGMP manufacturing facility. Prior to this, he served as COO at Gamida Cell, where he directed all operational activities towards its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for omidubicel. Mr. Palash was COO at Protalix Biotherapeutics, where he led all operational activities through the company’s FDA approval of Elelyso®. Prior to Protalix, Mr. Palash was a General Manager at ColBar LifeScience, a biomaterial company acquired by Johnson & Johnson, where he led the planning, construction, scale-up and regulatory oversight of its Israel-based manufacturing facility. He also successfully led FDA audits for Evolence® and Ossix® and was a member of the Global Aesthetic Management Team within the Consumer Group of Johnson & Johnson. Earlier in his career, Mr. Palash held operational roles at Teva Pharmaceutical Industries and Interpham Laboratories. Tillkännagivande • Jun 10
MediWound Ltd., Annual General Meeting, Jul 19, 2022 MediWound Ltd., Annual General Meeting, Jul 19, 2022, at 10:00 US Eastern Standard Time. Location: offices of Latham & Watkins LLP, Conference Center, 1271 Avenue of the Americas New York New York United States Agenda: To approve the re-appointment of Somekh Chaikin, a member firm of KPMG, as the Company’s independent registered public accounting firm until the next annual general meeting of shareholders of the Company and to authorize the Board (with power of delegation to its audit committee) to fix the independent registered public accounting firm’s remuneration in accordance with the volume and nature of its services; to consider directorate reelections; to approve and ratify the terms of the Company’s renewed Directors and Officers liability insurance policy for the period from April 1, 2022 through March 31, 2023; and to consider other matters. Reported Earnings • May 18
First quarter 2022 earnings released: US$0.13 loss per share (vs US$0.10 loss in 1Q 2021) First quarter 2022 results: US$0.13 loss per share (down from US$0.10 loss in 1Q 2021). Revenue: US$4.41m (down 25% from 1Q 2021). Net loss: US$3.59m (loss widened 26% from 1Q 2021). Over the next year, revenue is forecast to grow 6.0%, compared to a 6.6% growth forecast for the industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 52 percentage points per year, which is a significant difference in performance. Tillkännagivande • May 13
MediWound Ltd. Announces Positive Results from U.S. Phase 2 Clinical Study of Escharex® for the Debridement of Venous Leg Ulcers MediWound Ltd. announced positive results from its U.S. Phase 2 clinical study of EscharEx® for the debridement of venous leg ulcers (VLUs). The study met its primary endpoint, its key secondary endpoints with high degree of statistical significance, as well as its wound closure safety measurements. MediWound anticipates meeting with the U.S. Food and Drug Administration in the second half of 2022, for an End-of-Phase 2 meeting to discuss study results and a potential Phase 3 pivotal plan for EscharEx. U.S. key opinion leaders will join MediWound management in its coming earning call on May 17 at 8:30am EDT to discuss the data. The study met its primary endpoint with a high degree of statistical significance, demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement during the 14-day measurement period within up to 8 applications compared to gel vehicle (EscharEx: 63% (29/46) vs. gel vehicle: 30% (13/43), p-value=0.004). EscharEx efficacy superiority remained statistically significant compared to gel vehicle after adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size, wound age and regions. The study met key secondary and exploratory endpoints. Patients treated with EscharEx had a statistically significant higher incidence of complete debridement, during the same 14-day measurement period, compared to patients treated by non-surgical standard-of-care ("NSSOC") (EscharEx: 63% (29/46) vs. NSSOC: 13% (4/30)) and the time to achieve complete debridement was significantly shorter. Estimated median time to complete debridement, was 9 days for patients treated with EscharEx and 59 days for patients treated with NSSOC (p-value=0.016). On average, complete debridement was achieved after 3.6 applications of EscharEx compared to 12.8 applications with NSSOC. Patients treated with EscharEx demonstrated significantly higher incidence of at least 75% granulation tissue at the end of the treatment period compared to gel vehicle (p-value <0.0001). Favorable trends were observed in wound area reduction and reduction of pain compared to gel vehicle. In addition, the study showed that EscharEx was safe and well tolerated, and the overall safety was comparable between the arms as assessed by the data safety monitoring board. Importantly, there were no observed deleterious effects on wound closure and no material differences in reported adverse events. Estimated time to complete wound closure was 64 days for patients treated with EscharEx compared to 78 days for patients treated with NSSOC. Tillkännagivande • May 12
MediWound Ltd. to Report Q1, 2022 Results on May 17, 2022 MediWound Ltd. announced that they will report Q1, 2022 results on May 17, 2022 Reported Earnings • Mar 18
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: US$0.50 loss per share (down from US$0.34 loss in FY 2020). Revenue: US$23.8m (up 9.2% from FY 2020). Net loss: US$13.6m (loss widened 46% from FY 2020). Revenue was in line with analyst estimates. Over the next year, revenue is forecast to grow 6.1%, compared to a 8.2% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 38 percentage points per year, which is a significant difference in performance. Tillkännagivande • Feb 18
U.S. Department of Defense Awards Defense Research Grant to Mediwound Ltd. for the Development of Nexobrid for the U.S. Army MediWound Ltd. announced that the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium, has awarded MediWound a $1.7 million research project for the development of NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army. The MTEC Research Project Award was granted by the DoD’s USAMRDC through MTEC, a biomedical technology consortium working to advance innovative medical solutions to keep military personnel healthy and fully operational. Field solutions for severe burn treatment that are simple and effective enough to be used in a pre-hospital setting as early as the point of injury and requiring minimal preparation and training, are needed to ensure optimal outcomes to combat personnel. The MTEC Research Project Award includes $1.7 million of funding to support development activities of NexoBrid over the next 24 months as a non-surgical debriding solution to treat severe burn injuries in a pre-hospital setting. Tillkännagivande • Feb 12
MediWound Ltd. announced that it has received $9 million in funding from Biomedical Advanced Research And Development Authority MediWound Ltd. announced that it has received $9 million in a round of funding on February 10, 2022. The transaction included participation from new investor Biomedical Advanced Research And Development Authority. Tillkännagivande • Jan 25
Mediwound Announces Positive Topline Results from Its U.S. Phase 2 Trial of Escharex for Debridement of Chronic Wounds MediWound Ltd. announced positive topline results from its U.S. Phase 2 clinical study of EscharEx® for the debridement of venous leg ulcers (VLUs). The study met its primary endpoint, demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement compared to the gel vehicle, with a p-value of 0.004. The study randomized 120 patients, of which 119 patients were treated by either EscharEx (n=46), a gel vehicle (n=43), or a non-surgical standard-of-care consisting of either enzymatic or autolytic debridement (n=30). The study met its primary endpoint with high degree of statistical significance. Patients treated with EscharEx demonstrated a higher incidence of complete debridement during the 14-day measurement period within up to 8 applications compared to patients treated with gel vehicle (EscharEx: 63% (29/46) vs. gel vehicle: 30% (13/43), p-value=0.004). After adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size and age, regions, and sites, EscharEx efficacy superiority remained statistically significant compared to gel vehicle. Incidence of complete debridement of the non-surgical standard-of-care arm, during the same 14-day measurement period, was 13% (4/30). In addition, the Independent Data Monitoring Committee reviewed the data of all patients treated and no safety concerns were identified in the study population. EscharEx was well-tolerated and overall safety was comparable between the arms. No differences were found in reported adverse events and no serious adverse event was related to study treatment. Patient baseline characteristics were comparable across all study arms. Patient follow-up is ongoing and additional data, including secondary and exploratory endpoints as well as additional safety measurements, which will allow further evaluation of clinical benefits, is expected in the second quarter of 2022. MediWound currently expects to request an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (the “FDA”) in the second half of 2022, to discuss program results and the potential Phase 3 pivotal plan for EscharEx. Tillkännagivande • Dec 21
MediWound Announces Positive Initial Data from its U.S. Phase 2 Pharmacology Study of EscharEx Showing Effective and Rapid Debridement in Chronic and Hard to Heal Wounds MediWound Ltd. announced positive initial data from seven of the maximum fifteen patients in its ongoing open-label, phase 2 pharmacology study of EscharEx®, the company’s next-generation enzymatic debridement agent under development for chronic and hard-to-heal wounds. The company expects to share the full data set from this study in the first half of 2022. Based on the data generated to date, following treatment of seven patients with either diabetic foot ulcers (DFU’s) or venous leg ulcers (VLU’s), EscharEx demonstrated safe and effective debridement of lower leg ulcer within a few daily applications. In addition, evaluation of wounds’ tissue samples (biopsies) and fluorescence images, indicated reduction of biofilm and bacterial load following the treatment with EscharEx. The phase 2 pharmacology study, which remains ongoing, is a prospective, open label, single-arm study, being conducted at three U.S. clinical sites. The study is designed to evaluate the clinical performance, safety, and pharmacology effect of EscharEx in the debridement of lower leg ulcers (VLUs and DFUs) in up to fifteen patients. The study evaluates the safety and efficacy of debridement as measured by incidence of, and time to complete debridement. In addition, the study evaluates the pharmacological effects of EscharEx as measured by the changes from baseline to end of treatment period in (1) wound biofilm presence in wound biopsies, (2) bacterial burden measured by MolecuLight® fluorescence images, and (3) biomarkers of wound healing and inflammation in wound fluid. Tillkännagivande • Dec 07
MediWound Completes Enrollment of its EscharEx U.S. Phase 2 Adaptive Design Study MediWound Ltd. announced it has completed patient enrollment in its U.S. Phase 2 adaptive design clinical study evaluating the safety and efficacy of EscharEx® in debridement of venous leg ulcers (VLUs) compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement). In July 2021, the company reported a positive outcome from its planned interim assessment on sample-size re-estimation for this study, conducted after 80 patients were treated, with no changes to the original study sample size of 120 patients and no safety concerns identified. Topline data from clinical study is now anticipated in the first quarter of 2022. The study is a multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs. The study enrolled 120 patients at approximately 20 clinical sites, primarily in the U.S. Study participants were randomized to either EscharEx, placebo control or non-surgical standard-of-care of either enzymatic or autolytic debridement, at a ratio of 3:3:2, with a three-month follow-up. The primary endpoint is incidence of complete debridement compared to gel vehicle placebo control. Secondary endpoints include time to achieve complete debridement, reduction of pain, reduction of wound area, granulation tissue and quality of life. Incidence and time to achieve wound closure will be assessed as safety measurements. The study included a pre-defined interim assessment for futility and potential sample size adjustment. The Independent Data Monitoring Committee’s (IDMC) conducted the pre-specified interim conditional power assessment, after 80 patients out of the originally targeted of 120 patients completed the debridement treatment and recommended that no changes to the original enrollment target of 120 patients was required to maintain the pre-specified statistical power of 80% or greater on the study’s primary endpoint of incidence of complete debridement compared with gel vehicle. In addition, the IDMC reviewed the data of all subjects treated and no safety concerns were identified in the study population. As part of the Company’s broader EscharEx development program, MediWound is also conducting a phase 2 open-label, single arm study assessing the pharmacological effects of EscharEx in up to 15 patients with both diabetic foot ulcers (DFUs) and VLUs. The objective of this study is to gain a better understanding of what is happening in the wound bed, both during and after debridement with EscharEx, and to assess its effect on biofilm burden, reduction in inflammation, and the initiation of wound healing. MediWound expects to generate data from this study in the second half of 2021. Reported Earnings • Nov 18
Third quarter 2021 earnings released: US$0.12 loss per share (vs US$0.073 loss in 3Q 2020) The company reported a poor third quarter result with increased losses, weaker revenues and weaker control over costs. Third quarter 2021 results: Revenue: US$6.37m (down 3.8% from 3Q 2020). Net loss: US$3.35m (loss widened 68% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 35% per year but the company’s share price has only fallen by 18% per year, which means it has not declined as severely as earnings. Reported Earnings • Aug 11
Second quarter 2021 earnings released: US$0.12 loss per share (vs US$0.11 loss in 2Q 2020) The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: US$6.06m (up 50% from 2Q 2020). Net loss: US$3.20m (loss widened 3.2% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 8% per year but the company’s share price has fallen by 18% per year, which means it is performing significantly worse than earnings. Tillkännagivande • Jun 30
MediWound Receives Complete Response Letter from U.S. FDA for NexoBrid Biologics License Application MediWound Ltd. announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA communicated that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls (“CMC”) section of the BLA and requested additional CMC information. The FDA acknowledged receipt of several CMC amendments, submitted in response the CMC information requests, which were not reviewed for this action. Tillkännagivande • Jun 10
MediWound Completes Patient Enrollment for Interim Assessment of U.S. EscharEx Phase 2 Adaptive Design Study MediWound Ltd. 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 achieved, and interim assessment is expected by the end of July 2021. The pre-defined interim assessment is for futility analysis and potential sample size adjustment. This study, which is targeted to enroll a total of 120 patients by year-end 2021, is designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement). As part of the company’s broader EscharEx development program, MediWound is also conducting a phase 2 open-label, single arm study assessing the pharmacological effects of EscharEx in up to 15 patients with both diabetic foot ulcers (DFUs) and VLUs. The objective of this study is to gain a better understanding of what is happening in the wound bed, both during and after debridement with EscharEx, and to assess its effect on biofilm burden, reduction in inflammation, and the initiation of wound healing. The company expects to generate data from this study in the second half of 2021. Reported Earnings • May 06
First quarter 2021 earnings released: US$0.10 loss per share (vs US$0.09 loss in 1Q 2020) The company reported a solid first quarter result with improved revenues and control over costs, although losses increased. First quarter 2021 results: Revenue: US$5.85m (up 32% from 1Q 2020). Net loss: US$2.85m (loss widened 16% from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings. Reported Earnings • Feb 26
Full year 2020 earnings released: US$0.34 loss per share (vs US$0.076 profit in FY 2019) The company reported a poor full year result with weaker earnings, revenues and control over costs. Full year 2020 results: Revenue: US$21.8m (down 32% from FY 2019). Net loss: US$9.28m (down US$11.3m from profit in FY 2019). Over the last 3 years on average, earnings per share has increased by 36% per year but the company’s share price has only increased by 9% per year, which means it is significantly lagging earnings growth. Analyst Estimate Surprise Post Earnings • Feb 26
Revenue beats expectations Revenue exceeded analyst estimates by 5.2%. Over the next year, revenue is forecast to grow 41%, compared to a 2.1% growth forecast for the Pharmaceuticals industry in Germany. Tillkännagivande • Feb 23
MediWound Ltd. Launches Clinical Development Program for Treatment of Non-Melanoma Skin Cancer MediWound Ltd. 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. 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. Tillkännagivande • Feb 17
MediWound Ltd. to Report Q4, 2020 Results on Feb 25, 2021 MediWound Ltd. announced that they will report Q4, 2020 results at 7:00 AM, US Eastern Standard Time on Feb 25, 2021 Is New 90 Day High Low • Feb 05
New 90-day high: €4.52 The company is up 45% from its price of €3.12 on 06 November 2020. The German market is up 14% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 10.0% over the same period. Is New 90 Day High Low • Jan 14
New 90-day high: €3.76 The company is up 25% from its price of €3.02 on 16 October 2020. The German market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 19% over the same period. Tillkännagivande • Jan 12
MediWound Ltd. Provides Progress Update on its EscharEx Clinical Development Program MediWound Ltd. 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. Tillkännagivande • Dec 23
MediWound Ltd. Announces Successful Completion of In-Vivo Head-to-Head Comparator Study of EscharEx versus a Commercial Enzymatic Debridement Agent MediWound Ltd. announced the successful completion of a pre-clinical study designed to evaluate the debridement efficacy of EscharEx®, a novel bromelain-based enzymatic debridement agent, in a porcine hard-to-heal wound model, and compare its efficacy with an FDA approved and commercially available collagenase enzymatic debridement agent. The study concluded that EscharEx treatment was more effective than the commercially available collagenase agent in removing eschars in this model. Results from the study will be published in a peer-reviewed journal in the first half of 2021. The study, conducted in collaboration with a U.S. research center, was performed as part of MediWound’s pharmacological evaluation of EscharEx’s effect on chronic wounds, using a novel porcine eschar model designed to evaluate the efficacy of enzymatic debridement agents. The primary objective of the study was to compare the debridement efficacy of various concentrations of EscharEx, a novel bromelain-based enzymatic agent (second generation EscharEx formulation), with a commercially available collagenase debridement agent. Efficacy was evaluated based on the number of treatments of various concentrations of EscharEx and the collagenase agent needed to achieve complete eschar removal (greater than 95%), as assessed clinically. With EscharEx treatment, complete eschar removal was achieved in all treated wounds, at all dose concentrations, within a maximum of ten 24-hour applications, and dose-dependency was observed in the time to complete debridement. After ten applications, the maximum number of applications needed to achieve complete eschar removal with EscharEx at its lower dose, none of the wounds treated with the collagenase enzymatic agent achieved complete eschar removal. 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. 
