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]

MediWound FY Conference Summary Company Overview - **Company**: MediWound (NasdaqGM:MDWD) - **Industry**: Biotech, specifically focused on wound care and debridement products Key Points and Arguments Business Strategy - MediWound is a biotech company with a biologic technology validated in 14 clinical trials, with its first product approved by both FDA and EMA, and available in over 40 countries [4][5] - The company utilizes enzymatic technology to replace surgeries for severe burns and chronic wounds, with the first product achieving eschar removal in four hours [5] Market Opportunities - The addressable market for the second indication (EscharEx) is estimated at $2.5 billion, with ongoing pivotal phase three studies [6] - The company has collaborations with major players in the field to enhance treatment options for patients [6][14] Upcoming Catalysts - Significant catalysts expected in the next 6-12 months include: 1. Anticipated success in securing a significant portion of a ten-year BARDA contract [9] 2. Completion of a new manufacturing facility by the end of the year, which will alleviate current manufacturing bottlenecks [10] 3. An interim look at the phase three study results by mid-2026, which could indicate potential peak sales of $700 million [11] Clinical Trials and Collaborations - The phase three study for EscharEx is the largest clinical trial for venous leg ulcers in decades, with a high probability of success (90%) [18][19] - Collaborations with seven of the largest wound care companies to ensure the best treatment options for trial patients [16] Risk Management - The interim assessment aims to minimize risk and ensure the trial maintains a 90% probability of success [19][20] - Previous trials have shown a significant gap between MediWound's product and placebo, indicating strong potential for success [22] Manufacturing and Supply Chain - Discussions with the US government for funding a manufacturing facility, with plans to secure full funding [27] - The new facility in the US, along with existing facilities in Israel, will provide sufficient capacity for EscharEx's launch [27] Financial Position - Current cash position is $33 million, with an additional $30 million available through warrants [46] - Clinical trial costs are approximately $25 million, indicating a relatively stable financial situation [46] Market Performance of NexoBrid - NexoBrid has seen a 52% increase in revenue compared to the previous quarter, with strong adoption reported by burn centers [30] - Lessons learned from NexoBrid's commercialization will inform the launch strategy for EscharEx, which is expected to have a quicker uptake due to its replacement of existing products [31][32] Government Contracts and Future Developments - The new BARDA RFP includes stockpiling and development programs for NexoBrid, indicating continued government interest and investment [39][40] - The development of a room temperature stable formulation for NexoBrid is aimed at expanding its market reach [44][45] Additional Important Information - The company is prioritizing support for the US commercial market and the Israeli market due to current geopolitical circumstances [34] - The potential for a room temperature stable formulation could significantly enhance the product's usability in emergency situations [44][45]

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]

Group 1 - MediWound Ltd. (MDWD) is a stock that highlights the risks associated with obscurity in the investment landscape, particularly in the biomedical startup sector [1] - The company has seen its shares peak at over $41 each, indicating significant investor interest [1] Group 2 - The article is written by an analyst who holds a beneficial long position in MDWD shares, suggesting a personal investment interest in the company's performance [2] - The analyst emphasizes that the views expressed are personal opinions and not influenced by any business relationships with the company [2]

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 Viewpoint - MediWound reported a quarterly loss of $1.23 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.55, marking an earnings surprise of -123.64% [1] - The company posted revenues of $5.71 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 1.89% and showing growth from $5.06 million a year ago [2] Financial Performance - The company has surpassed consensus EPS estimates two times over the last four quarters [2] - The current consensus EPS estimate for the upcoming quarter is -$0.64 on revenues of $6.68 million, and for the current fiscal year, it is -$1.99 on revenues of $23.97 million [7] Stock Performance - MediWound shares have increased by approximately 5.3% since the beginning of the year, compared to a 10% gain in the S&P 500 [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Outlook - The Medical - Drugs industry is currently in the top 35% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

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]