Core Insights - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics for tissue repair, with a focus on developing and commercializing enzymatic therapies for non-surgical tissue repair [3]. Company Overview - MediWound's FDA-approved product, NexoBrid, is designed for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets [3]. - The company is advancing EscharEx, a late-stage investigational therapy for the debridement of chronic wounds, which has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity [3]. Upcoming Events - Ofer Gonen, the CEO of MediWound, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 4:30 p.m. ET [1]. - A live webcast of the event will be available on MediWound's website [2].

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 was $5.7 million, up from $5.1 million in Q2 2024, reflecting a 43% sequential growth and an increase year over year [10] - Gross profit for the quarter was $1.3 million, representing 23.5% of revenue, compared to $400,000 or 8.8% in the prior year period, indicating a significant margin increase [11] - Net loss for Q2 2025 was $13.3 million or $1.23 per share, compared to a net loss of $6.3 million or $0.68 per share in the same period last year [12] Business Line Data and Key Metrics Changes - NexoBrid reported a 52% year-over-year revenue growth in Q2 2025, driven by increases in hospital unit orders and the number of ordering centers [8] - Research and development expenses rose to $3.5 million in Q2 2025 from $1.9 million in Q2 2024, primarily due to investments in the EscharEx VALUE Phase III study [11] Market Data and Key Metrics Changes - The EscharEx VALUE Phase III trial is actively enrolling patients, aiming to enroll 216 patients across 40 sites in the U.S. and Europe [5] - The commissioning of the new manufacturing facility is on track for completion by year-end 2025, which is critical for supporting global growth [9] Company Strategy and Development Direction - The company remains focused on three core objectives: advancing the EscharEx VALUE Phase III trial, completing the commissioning of the expanded manufacturing facility, and building global recognition of EscharEx through clinical collaborations and publications [17] - The company has established new collaborations with ConvaTec and SCT to support ongoing trials, reinforcing the validation of EscharEx within the wound care ecosystem [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving several key milestones over the next twelve months, which are expected to advance strategic and financial objectives [5] - The company noted that the demand for NexoBrid is rising, and they are addressing capacity issues to support global growth [67] Other Important Information - The company received an additional $3.6 million in non-dilutive funding from the U.S. Department of Defense, bringing total program funding to $18.2 million [9] - As of June 30, 2025, the company had $32.9 million in cash and cash equivalents, down from $43.6 million at the end of 2024 [14] Q&A Session Summary Question: Are there any upcoming publications to be aware of? - Management indicated that there are several publications planned, particularly focusing on diabetic foot ulcer trials, with expectations for additional publications around major conferences [20] Question: Can you provide an update on the head-to-head trial versus Santyl? - The randomized study comparing EscharEx directly to collagenase is on track, with plans to enroll 45 VLU patients [21] Question: What is the status of the U.S. facility and BARDA funding? - The U.S. facility planning is fully funded by BARDA, and the company is preparing for the next steps in discussions with the U.S. government regarding the facility's funding [23][24] Question: How is the patient recruitment for the VALUE study progressing? - Enrollment is progressing well, with most U.S. sites active and recruiting, while European site activation is slightly slower due to regulatory timelines [41] Question: What areas are underserved for NexoBrid? - Demand is substantial across all regions, and the company is focused on meeting guidance for upcoming years, with expectations for better clarity on demand after the new facility is completed [46] Question: What are the expected timelines for the new NexoBrid facility? - The company expects to file for regulatory approvals in the EU and the U.S. in 2026, with EMA approval anticipated first [68]

Core Insights - MediWound Ltd. announced the publication of a post hoc analysis demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs) [1][4] Group 1: Study Details - The analysis included data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive treatments with either EscharEx, a placebo gel, or non-surgical standard care, followed by weekly dressings for 12 weeks [2] - WBP was defined as the complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue [2] Group 2: Key Findings - Wounds that failed to achieve WBP had a 90% probability of not healing, indicating a high negative predictive value [7] - Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not, with a statistical significance of p = 0.0004 [7] - Early achievement of WBP (within 14 days) significantly increased the likelihood of healing, with a relative risk of 2.4 (p = 0.0005) [7] - Wounds that did not reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (hazard ratio = 12, p < 0.0001) [7] Group 3: Implications for Therapy - The findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure [4] - EscharEx has demonstrated therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers [4][5] Group 4: About EscharEx - EscharEx is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds, showing a favorable safety profile and effective wound bed preparation [6] - A global Phase III study in venous leg ulcers is currently underway, with a clinical study in diabetic foot ulcers in preparation [6]

Core Viewpoint - MediWound Ltd. is set to release its financial results for the second quarter of 2025 on August 14, 2025, and will host a conference call to discuss these results and provide corporate updates [1][2]. Company Overview - MediWound Ltd. is a global biotechnology company specializing in enzymatic therapies for non-surgical tissue repair. The company’s FDA-approved product, NexoBrid, is used for the enzymatic removal of eschar in thermal burns and is marketed in multiple regions including the U.S., European Union, and Japan [3]. - The company is also developing EscharEx, a late-stage investigational therapy aimed at chronic wound debridement, which has shown clinical advantages over existing products and targets a significant global market opportunity [3].

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $4 million, down from $5 million in Q1 2024, primarily due to lower revenue from BARDA funded development services as the NexoBrid development program nears completion [15] - Gross profit for the quarter was $700,000, representing a gross margin of 19%, compared to $600,000 and a gross margin of 12% in the prior year [15] - Operating loss for the quarter was $5.2 million, compared to $3.7 million in Q1 2024 [16] - Net loss was $700,000 or $0.07 per share, an improvement from a net loss of $9.7 million or $1.05 per share in the previous year [16] - Adjusted EBITDA loss for the quarter was $4 million, compared to $2.9 million in the prior year [16] - Cash and cash equivalents as of March 31, 2025, were $38.7 million, down from $43.6 million at year-end 2024 [17] Business Line Data and Key Metrics Changes - The VALUE Phase III study for EscharEx is on track, with recruitment progressing as planned, aiming to enroll 216 patients across approximately 40 sites in the U.S. and Europe [5][6] - NexoBrid revenue reported a 207% year-over-year increase and a 31% sequential increase during Q1 2025, with consistent ordering from nearly 60 burn centers in the U.S. [11] - Demand for NexoBrid continues to exceed manufacturing capacity in Japan and Europe, with a new manufacturing facility expected to be operational by year-end 2025 [12] Market Data and Key Metrics Changes - The company has secured a €2,500,000 grant from the European Innovation Council Accelerator to support clinical and regulatory advancement of EscharEx for diabetic foot ulcers [8] - The company is experiencing growing interest from governments for stockpiling NexoBrid as part of global emergency preparedness efforts [14] Company Strategy and Development Direction - The company is focused on scaling manufacturing capabilities to support long-term growth, with a new facility progressing on schedule and U.S. expansion plans underway [19] - Strategic research collaborations have been strengthened, with participation from major global wound care companies in clinical development programs [8] - The company aims to position EscharEx as a global leader in enzymatic wound debridement, supported by strong clinical data and partnerships [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical, commercial, and operational priorities, maintaining momentum from 2024 [4] - The company anticipates that the VALUE Phase III trial will yield positive results, which would support regulatory submissions and commercial positioning [6] - Management noted that the U.S. government has shown interest in establishing a domestic backup manufacturing site, with planning for this project expected to be completed by Q3 2025 [26] Other Important Information - The company is planning a 45-patient randomized prospective Phase II head-to-head comparison of EscharEx versus collagenase, scheduled to begin in the second half of 2025 [7] - The company is also preparing for potential stockpiling of NexoBrid, with discussions ongoing with various governments [36] Q&A Session Summary Question: What is yet to be done for manufacturing scale-up by year-end? - The construction of the new facility is complete, and the company is in the commissioning phase, expecting operational capacity by the end of 2025 [24] Question: When should investors expect movement on U.S. capacity? - The project for a domestic backup manufacturing site is expected to be finished by Q3 this year, with further details to follow [27] Question: How is enrollment progressing for the VLU study? - Recruitment is progressing as planned, with excitement from leading wound care companies and key opinion leaders [30] Question: How is the company planning for stockpiling of NexoBrid? - The company prefers to treat patients rather than stockpile, but there is growing interest from governments for stockpiling [36] Question: What is the structure of the sites for the EscharEx trial? - Approximately 50% of the sites will be in the U.S., with a focus on recruiting the right patients [38] Question: Will the head-to-head study results come before the Phase III study? - The head-to-head study is expected to finish ahead of the Phase III study due to its shorter duration [42] Question: What factors will influence the pricing strategy for EscharEx? - The pricing strategy will consider the cost of treatment duration and health economics related to faster debridement [50] Question: How will the new U.S. backup manufacturing facility support demand? - The facility will not only serve as a backup but also expand manufacturing capabilities for both NexoBrid and EscharEx [53]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $4 million, down from $5 million in Q1 2024, primarily due to lower revenue from BARDA funded development services as the NexoBrid development program nears completion [17] - Gross profit for the quarter was $700,000, representing a gross margin of 19%, compared to $600,000 and a gross margin of 12% in the prior year [17] - R&D expenses totaled $2.9 million, up from $1.5 million in Q1 2024, reflecting continued investment in the EscharEx VALUE Phase III trial [17] - SG&A expenses were $3.1 million, compared to $2.9 million in the prior year [17] - Operating loss for the quarter was $5.2 million, compared to $3.7 million in Q1 2024 [17] - Net loss was $700,000 or $0.07 per share, an improvement from a net loss of $9.7 million or $1.05 per share last year [17] - Adjusted EBITDA loss for the quarter was $4 million, compared to $2.9 million in the prior year [17] - Cash, cash equivalents, and deposits as of March 31, 2025, were $38.7 million, down from $43.6 million at year-end 2024 [19] Business Line Data and Key Metrics Changes - The VALUE Phase III study for EscharEx is on track, with recruitment progressing as planned, aiming to enroll 216 patients across approximately 40 sites in the U.S. and Europe [5][6] - NexoBrid's U.S. adoption continues to expand, with a 207% year-over-year increase and a 31% sequential increase in revenue during Q1 2025 [12] - Demand for NexoBrid in Japan and Europe continues to exceed manufacturing capacity, with a new manufacturing facility expected to be operational by year-end 2025 [12][13] Market Data and Key Metrics Changes - The company has secured a €2,500,000 grant from the European Innovation Council Accelerator to support the clinical and regulatory advancement of EscharEx for diabetic foot ulcers [9] - The U.S. government has expressed interest in establishing a domestic backup manufacturing site for NexoBrid, supported by BARDA [15][25] Company Strategy and Development Direction - The company is focused on scaling manufacturing capabilities to support long-term growth, with a new facility progressing on schedule and U.S. expansion plans underway [21] - EscharEx is positioned to become a global leader in enzymatic wound debridement, with strong clinical advantages over competitors [11] - The company is advancing complementary studies to support market access and future commercial success [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical, commercial, and operational priorities, maintaining momentum from 2024 [4] - The company anticipates achieving operational capacity for the new manufacturing facility by the end of 2025, with regulatory inspections expected thereafter [25] - Management remains optimistic about the VALUE Phase III trial and expects interim data by mid-2026 [31] Other Important Information - The company is planning a 45-patient randomized prospective Phase II head-to-head comparison of EscharEx versus collagenase, scheduled to begin in the second half of 2025 [7] - The pediatric Phase III study results for NexoBrid were published, reinforcing its efficacy and safety [13] Q&A Session Summary Question: What is yet to be done for manufacturing scale-up by year-end? - The construction of the new facility is complete, and the company is in the commissioning phase, expecting operational capacity by the end of 2025 [25] Question: When should investors expect movement on U.S. capacity? - The project for a domestic backup manufacturing site is expected to be finished by Q3 this year, with further details to follow [28] Question: How is enrollment progressing for the VLU study? - Recruitment is progressing as planned, with excitement from leading wound care companies and key opinion leaders [31] Question: How is the stockpiling of NexoBrid being planned? - The company prefers to treat patients rather than stockpile, but there is growing interest from governments for stockpiling [37] Question: What is the structure of the EscharEx trial sites? - Approximately 50% of the sites will be in the U.S., with a focus on recruiting the right patients [39] Question: Will the results of the head-to-head study and phase three study come around the same time? - The head-to-head study is expected to finish ahead of the phase three study due to its shorter duration [43] Question: What factors will influence the pricing strategy for EscharEx? - The pricing strategy will consider treatment costs, health economics, and potential savings from faster debridement [51] Question: How should investors think about BARDA and DoD funding? - The company anticipates no material impact on revenue outlook for 2025, with programs back on track [61]

Core Insights - MediWound Ltd. reported a first-quarter revenue of $4 million for 2025, reaffirming full-year revenue guidance at $24 million [1][6] - The VALUE Phase III trial for EscharEx is progressing as planned, with recruitment underway for 216 patients across 40 clinical sites [5][2] - NexoBrid's revenue saw a significant increase, with Vericel reporting a 207% year-over-year growth for the first quarter of 2025 [4][2] Financial Performance - Total revenue for Q1 2025 was $3.955 million, down from $4.964 million in Q1 2024 [24] - Gross profit for the quarter was $738,000, resulting in a gross margin of 19%, compared to $607,000 and 12% in the prior year [24] - Operating loss for Q1 2025 was $5.225 million, compared to a loss of $3.734 million in Q1 2024 [24] Clinical Developments - The VALUE Phase III study for EscharEx is designed to enroll 216 patients, with most U.S. sites already open and European sites expected to activate in Q3 2025 [5][2] - A head-to-head Phase II study comparing EscharEx to collagenase has been submitted to the FDA, expected to start in the second half of 2025 [5][2] - EscharEx demonstrated superior efficacy in a post hoc analysis compared to collagenase ointment, achieving faster debridement and improved wound closure outcomes [5][6] Strategic Collaborations - MediWound has established strategic research collaborations with leading wound care companies, enhancing the validation of EscharEx [5][2] - Kerecis will provide its MariGen Fish-Skin graft for the diabetic foot ulcers trial, marking a significant collaboration [5][2] Manufacturing and Operational Updates - The company is on track with the expansion of NexoBrid manufacturing, expecting full operational capacity by the end of 2025 [1][2] - A BARDA-funded planning process for future U.S.-based manufacturing capabilities is underway [11][2] Balance Sheet Highlights - As of March 31, 2025, cash and cash equivalents totaled $38.7 million, down from $43.6 million at the end of 2024 [7] - The company used $5.1 million to fund operations during Q1 2025 [7]

Core Insights - MediWound Ltd. is presenting 10 scientific abstracts at the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2025, focusing on EscharEx's mechanism of action and its advantages over SANTYL in treating chronic wounds [1][2][4] Company Overview - MediWound Ltd. is a global biotechnology company specializing in enzymatic therapies for non-surgical tissue repair, with its FDA-approved product NexoBrid for thermal burns [6][7] Product Information - EscharEx is a bromelain-based enzymatic therapy designed for the debridement of chronic wounds, showing a favorable safety profile and effective wound bed preparation in multiple Phase II trials [5][6] - The therapy has demonstrated the ability to remove non-viable tissue, promote granulation, and reduce bioburden and biofilm, targeting a substantial global market opportunity [5][7] Clinical Development - The ongoing VALUE Phase III study is enrolling patients with venous leg ulcers (VLUs), building on positive results from three completed Phase II studies that confirmed EscharEx's efficacy and safety [4][5] - A Phase II/III study in diabetic foot ulcers (DFUs) is in preparation, with new data supporting the planned clinical trial strategy [2][5] Conference Highlights - Key presentations at WHS and SAWC will include new in vitro data on EscharEx's multitargeted proteolytic activity, case studies in advanced DFUs and VLUs, and updates on the VALUE Phase III study design and enrollment progress [6][8]