MediWound (MDWD) “announced that it has entered into a definitive securities purchase agreement led by a prominent U.S.-based mutual fund and other healthcare-focused investors for the sale and purchase of 1,734,105 ordinary shares of the Company, par value NIS 0.07 per share, at a purchase price of $17.30 per share, in a registered direct offering. The Company expects to close the offering on or about September 30, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to th ...

Core Viewpoint - MediWound Ltd. has announced a registered direct offering of ordinary shares, aiming to raise approximately $30 million to support its pre-commercial activities for EscharEx and enhance manufacturing capabilities [1][2]. Group 1: Offering Details - The company will sell 1,734,105 ordinary shares at a price of $17.30 per share, with the offering expected to close around September 30, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering are anticipated to be about $30 million before deducting fees and expenses [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used to support EscharEx's pre-commercial activities, enhance large-scale manufacturing capabilities, and for general corporate purposes [2]. Group 3: Company Overview - MediWound Ltd. is a biotechnology company focused on developing enzymatic therapies for non-surgical tissue repair, with its FDA-approved product NexoBrid for thermal burns [5]. - The company is advancing EscharEx, a late-stage investigational therapy for chronic wound debridement, which has shown clinical advantages over leading products in the market [5].

Core Insights - MediWound has received marketing authorization for NexoBrid from Australia's Therapeutic Goods Administration (TGA), allowing its use for both adults and children with deep partial- and full-thickness thermal burns [1][2] - NexoBrid is now authorized in 45 countries, establishing it as a new standard of care in burn management, with a commercial launch expected in Australia in Q4 2025 [2][3] - The company is expanding its manufacturing capabilities, which are on track for completion by the end of 2025, to meet global demand for NexoBrid [2][3] Product Overview - NexoBrid is a topically administered biological orphan drug designed for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns, preserving viable tissue while removing non-viable tissue [4] - The product is already approved in over 40 countries, including the United States, European Union, and Japan [4][5] Company Background - MediWound Ltd. is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair, with NexoBrid being its FDA-approved product [5] - The company is also advancing EscharEx, a late-stage investigational therapy for chronic wound debridement, which has shown clinical advantages over leading products in the market [5] Market Expansion - The TGA approval of NexoBrid is seen as a significant step in improving access to innovative burn care solutions in Australia and opens opportunities for expansion into the broader Asia-Pacific region [3] - Balance Medical, MediWound's exclusive partner in Australia, is expected to initiate the commercial launch of NexoBrid in the fourth quarter of 2025 [2][3]

Core Insights - MediWound's NexoBrid will be featured in 36 scientific presentations at the 21st European Burns Association Congress, emphasizing its significance in burn care advancements [1][2][3] Group 1: NexoBrid's Clinical Impact - Presentations will showcase data on pediatric, elderly, and critically burned patients, demonstrating consistent benefits in survival, recovery, and scar outcomes, as well as its effectiveness in infection control and modulation of systemic inflammatory responses [2] - Comparative and long-term studies support NexoBrid's superiority over surgical excision, reinforcing its role in routine care and mass casualty scenarios [2] Group 2: Company Overview - MediWound Ltd. is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair, with NexoBrid being its FDA-approved biologic for the enzymatic removal of eschar in thermal burns [6] - The company is also advancing EscharEx, a late-stage investigational therapy for chronic wound debridement, which has shown clinical advantages over leading products [6] Group 3: Support and Funding - NexoBrid's development has received federal funding from the U.S. Department of Health and Human Services and BARDA, supporting pivotal clinical studies and the marketing approval process [5]

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. reported a revenue of $5.7 million for Q2 2025, reflecting a 43% increase from the previous quarter [5][12] - The company is actively enrolling patients in the VALUE Phase III trial for EscharEx, targeting 216 patients across 40 sites in the U.S. and Europe [6][2] - NexoBrid is gaining commercial traction in the U.S., with a reported 52% year-over-year revenue growth [6][2] Clinical Developments - The VALUE Phase III trial for EscharEx is ongoing, with an interim sample size assessment planned for mid-2026 [6] - New collaborations with Essity and Convatec have been established to support EscharEx trials, enhancing the company's clinical partnerships [6][2] - The trial now includes JOBST for compression therapy and will incorporate AQUACEL for wound dressing in the planned DFU trial [6] Financial Performance - Revenue for the first half of 2025 was $9.7 million, compared to $10.0 million in the same period of 2024 [12] - Gross profit for Q2 2025 was $1.3 million, representing 23.5% of total revenue, an improvement from 8.8% in the prior-year period [12] - Research and development expenses increased to $3.5 million in Q2 2025, driven by investments in the EscharEx VALUE Phase III trial [12] Manufacturing and Expansion - The commissioning of MediWound's expanded manufacturing facility is on track, with full operational readiness expected by year-end 2025 [6][2] - The facility is designed to increase NexoBrid production capacity six-fold to meet anticipated demand [6] Funding and Financial Position - The company received an additional $3.6 million in funding from the U.S. Department of Defense to advance NexoBrid's development [6] - As of June 30, 2025, MediWound had cash and cash equivalents of $32.9 million, down from $43.6 million at the end of 2024 [8]

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]