Core Viewpoint - MediWound Ltd. has initiated a pivotal Phase III trial named VALUE to evaluate the efficacy and safety of EscharEx for treating venous leg ulcers (VLUs), aiming to redefine the standard of care in chronic wound debridement [1][2][10] Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, specializing in the development and commercialization of innovative biologics [9] - The company’s first drug, NexoBrid, is an FDA- and EMA-approved orphan biologic for eschar removal in burns, significantly reducing the need for surgical interventions [10] Clinical Trial Details - The VALUE study is a global, multicenter, randomized, double-blind, placebo-controlled trial involving 216 patients across 40 sites in the U.S. and Europe [2][3] - Patients will be randomized 1:1 to receive either EscharEx or placebo, with up to eight daily applications over two weeks, followed by ten weeks of standardized wound management [2] - The primary endpoints include the incidence of complete debridement and complete wound closure, with secondary endpoints assessing granulation tissue, time to debridement, and changes in wound area [3] Strategic Collaborations - To support the VALUE trial, MediWound has established strategic research collaborations with industry leaders Solventum, Mölnlycke, and MIMEDX to ensure consistent wound management across study sites [4] Future Studies - 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 [5] - The company is also preparing for an adaptive design Phase II/III clinical trial targeting diabetic foot ulcers (DFUs), expected to begin in 2026 [5] Market Context - Venous leg ulcers affect approximately 2% of individuals aged 65 and older, with over 1.5 million new cases reported annually in the U.S., highlighting the urgent need for effective treatment options [6] - The current market leader in wound debridement, SANTYL, has a market size exceeding $375 million, indicating significant potential for EscharEx to capture market share [2][10]

Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, specializing in the development, production, and commercialization of innovative biologics that enhance existing standards of care while reducing healthcare costs and unnecessary surgeries [3][4]. Upcoming Events - The CEO of MediWound, Ofer Gonen, will participate in a fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, at 8:00 AM ET [1]. - A webcast link for the fireside chat will be available on MediWound's website, and the management team will also host one-on-one meetings during the conference [2]. Product Development - 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 burns, significantly reducing the need for surgical interventions [4]. - The company is advancing EscharEx, a promising candidate currently in Phase III development for the debridement of chronic wounds, which has shown distinct advantages over existing treatments in Phase II clinical trials [4].

Core Viewpoint - MediWound (MDWD) shares experienced an 8.5% increase, attributed to positive investor sentiment regarding the company's product pipeline and upcoming sales expectations [1][2]. Company Overview - MediWound is developing EscharEx, currently in mid to late-stage studies for treating various ulcer indications, with a regulatory filing for venous leg ulcers expected in 2025 [2]. - Another candidate, MW005, is in mid-stage development for non-melanoma skin cancer [2]. - The company markets NexoBrid, approved for eschar removal in patients with thermal burns, and is expected to see year-over-year sales growth in the upcoming quarterly release [2]. Financial Expectations - The company is projected to report a quarterly loss of $0.61 per share, reflecting a year-over-year change of -221.1% [3]. - Revenues are anticipated to be $5.8 million, representing an 8.6% increase from the same quarter last year [3]. - The consensus EPS estimate has been revised 0.6% lower over the last 30 days, indicating a negative trend in earnings estimate revisions [4]. Industry Context - MediWound is part of the Zacks Medical - Drugs industry, which includes other companies like Nektar Therapeutics (NKTR) [4]. - Nektar's consensus EPS estimate has changed by +0.2% over the past month, with a year-over-year change of +40.9% [5].

Company Overview - MediWound Ltd. is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair, specializing in the development, production, and commercialization of innovative biologics that enhance existing standards of care while reducing healthcare costs [8][9]. Product Development - MediWound is advancing EscharEx, a bioactive, multimodal debridement therapy for chronic and hard-to-heal wounds, currently in late-stage clinical development. EscharEx has shown safety and efficacy in previous Phase II trials and is set to initiate a Phase III study for venous leg ulcers (VLUs) imminently [7][9]. - The upcoming Phase III VALUE study will focus on EscharEx's application in VLUs, addressing a substantial unmet need in the treatment landscape for VLUs and diabetic foot ulcers (DFUs) [2][7]. Clinical Expertise - The virtual Key Opinion Leader (KOL) event will feature distinguished clinical experts, including Dr. John C. Lantis II, Dr. Vickie R. Driver, and Dr. Robert J. Snyder, who will discuss compelling results from Phase II studies, the upcoming Phase III study, and EscharEx's competitive advantages [2][3][4][5]. Market Opportunity - EscharEx presents a unique opportunity for significant market growth, with distinct advantages over the current market leader in the $360+ million chronic wound care market [9]. The event will highlight EscharEx's unique commercial potential and its role in addressing the unmet needs in wound care [2][7].

Financial Data and Key Metrics Changes - Revenue for Q3 2024 totaled $4.4 million, down from $4.8 million in Q3 2023, primarily due to lower revenue from BARDA Development Services [23] - Gross profit for Q3 2024 was $0.7 million, representing 16% of total revenue, compared to $0.9 million or 19% in Q3 2023 [24] - For the first nine months of 2024, total revenue reached $14.4 million, up from $13.3 million in the same period of 2023 [25] - Net loss for the first nine months was $26.3 million, or $2.72 per share, compared to a net loss of $5 million, or $0.56 per share in the same period of 2023 [27] - Cash, cash equivalents, and deposits totaled $46 million as of September 30, 2024, up from $42.1 million at year-end 2023 [28] Business Line Data and Key Metrics Changes - NexoBrid's commercial revenue met expectations, with a 43% quarter-over-quarter increase in revenue, reflecting its expanding impact in the U.S. burn care market [10] - EscharEx is preparing for a Phase III study in venous leg ulcers, with IND submission planned by year-end 2024 [15] Market Data and Key Metrics Changes - NexoBrid received FDA approval for pediatric use, expanding its label to cover patients from newborn to 18 years old [9] - The World Health Organization designated enzymatic debridement as an essential treatment for burn injuries, reinforcing NexoBrid's role in emergency response [11] Company Strategy and Development Direction - The company aims to increase manufacturing output six-fold with a new GMP-compliant facility expected to be operational by the end of 2025 [12] - A strategic partnership with Mölnlycke Health Care was secured, providing critical funding and access to commercial expertise [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for NexoBrid, driven by U.S. expansion and FDA pediatric approval [14] - The company anticipates $20 million in revenue for 2024, down from prior guidance of $24 million, due to capacity constraints and changes in funding requirements [13] Other Important Information - The company completed construction of a new manufacturing facility, with commissioning currently underway [12] - A virtual key opinion leader event is scheduled for January 8, 2025, to discuss the Phase III study of EscharEx [16] Q&A Session Summary Question: Phase III EscharEx and IND submission - Management confirmed that the IND submission is expected imminently by the end of the year, with patient enrollment anticipated to start 30 days after submission [36] Question: Head-to-head Phase II study EscharEx versus collagenase - The study is designed to bolster evidence for EscharEx's role in chronic wound care and is not a regulatory requirement [38] Question: NexoBrid manufacturing capacity increase - Management clarified that the new manufacturing facility is in the commissioning phase, with inspections for FDA and EMA expected soon [41] Question: WHO inclusion impact on stockpiling - The inclusion is expected to facilitate stockpiling agreements with European countries, with significant agreements anticipated by 2026 [49] Question: Category III CPT code benefits - Management indicated that while the code may not have immediate impact, it is part of a broader strategy to gather data and improve market penetration [54] Question: DFU study anticipation - A protocol needs to be written and clearance obtained from FDA and EMA, which is expected to take at least a year [56] Question: Temperature-stable formulation approval - Management expects a small trial will be needed for approval, pending completion of non-clinical and CMC requests [64] Question: Stockpiling opportunity size - The potential market for stockpiling is estimated to be in the low tens of millions of dollars, with further analysis ongoing [66]

Company Performance - MediWound reported a quarterly loss of $0.98 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.48, marking an earnings surprise of -104.17% [1] - The company's revenues for the quarter ended September 2024 were $4.36 million, missing the Zacks Consensus Estimate by 27.48%, and down from $4.78 million a year ago [2] - Over the last four quarters, MediWound has surpassed consensus EPS estimates two times and topped consensus revenue estimates twice [2] Stock Movement and Outlook - MediWound shares have increased approximately 70.4% since the beginning of the year, outperforming the S&P 500's gain of 25.5% [3] - The future performance of the stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.58 on revenues of $7.82 million, and for the current fiscal year, it is -$2.69 on revenues of $23.85 million [7] Industry Context - The Medical - Drugs industry, to which MediWound belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Performance - Total revenue for Q3 2024 was $4.4 million, a decrease from $4.8 million in Q3 2023, primarily due to lower BARDA development services revenue[13] - Gross profit for Q3 2024 was $0.7 million, representing 16% of total revenue, down from 19% in Q3 2023, reflecting a shift in revenue mix[13] - The company anticipates total revenue of $20 million for 2024, revised down from prior guidance of $24 million due to strong demand exceeding current manufacturing capacity[8] - Operating loss for Q3 2024 was $5.1 million, compared to a loss of $3.0 million in Q3 2023[15] - Net loss for Q3 2024 was $10.3 million, or $0.98 per share, compared to a net loss of $2.2 million, or $0.24 per share, in Q3 2023[15] - Total revenues for the nine months ended September 2024 increased to $14,382 thousand, up from $13,348 thousand for the same period in 2023, representing an increase of 7.7%[39] - Gross profit for the nine months ended September 2024 was $1,731 thousand, a decrease of 39.4% compared to $2,859 thousand for the same period in 2023[39] - Operating loss for the nine months ended September 2024 was $(13,299) thousand, compared to $(11,396) thousand for the same period in 2023, reflecting a deterioration of 16.7%[39] - Net loss for the nine months ended September 2024 was $(26,316) thousand, significantly higher than $(4,973) thousand for the same period in 2023, indicating a year-over-year increase of 429.5%[39] - The company reported a basic and diluted loss per share of $(2.72) for the nine months ended September 30, 2024, compared to $(0.56) for the same period in 2023[39] - The company reported a net loss of $(10,282) million for the quarter ending September 2024, compared to $(2,196) million for the same quarter in the previous year[45] - The total net loss for December 31, 2023, was $(6,716) million, showing a consistent trend of losses[45] Cash and Assets - As of September 30, 2024, cash and cash equivalents totaled $46.0 million, up from $42.1 million at the end of 2023[21] - Total current assets as of September 30, 2024, were $53,888 thousand, an increase from $53,250 thousand as of September 30, 2023[37] - Total non-current assets increased to $20,846 thousand as of September 30, 2024, compared to $13,767 thousand as of September 30, 2023, marking a growth of 51.4%[37] - Total liabilities and shareholders' equity as of September 30, 2024, were $74,734 thousand, up from $67,017 thousand as of September 30, 2023, reflecting an increase of 11.5%[37] - Cash and cash equivalents at the end of the period were $6,475 thousand, down from $9,279 thousand at the end of September 30, 2023, a decrease of 30.2%[43] Research and Development - R&D expenses for Q3 2024 were $2.5 million, an increase from $1.5 million in Q3 2023, mainly due to costs associated with the EscharEx Phase 3 clinical trial[14] - Research and development expenses for the nine months ended September 30, 2024, were $5,892 thousand, slightly up from $5,659 thousand for the same period in 2023[39] - The Phase 3 study of EscharEx for venous leg ulcers is set to commence, with FDA IND submission planned by year-end[9] Strategic Investments - The company raised $25 million through a strategic private investment in public equity (PIPE) to strengthen its cash runway[12] Adjusted Financial Metrics - Adjusted EBITDA for September 2024 was $(9,897) million, slightly worse than $(9,021) million in the same period last year[45] - Total adjustments amounted to $(16,419) million in September 2024, compared to $4,048 million in September 2023, reflecting a substantial negative shift[45] - Financial income (expenses), net for September 2024 was $(12,974) million, a decline from $6,488 million in September 2023[45] - Share-based compensation expenses increased to $(2,316) million in September 2024 from $(1,642) million in September 2023, indicating rising costs in this area[45] - Depreciation and amortization expenses rose to $(1,086) million in September 2024, compared to $(957) million in the same quarter last year[45] - Taxes on income were $(43) million in September 2024, slightly improved from $(65) million in September 2023[45] - Other income, net remained stable at $224 million in both September 2023 and December 31, 2023[45]

EscharEx IND Submission by Year-End; Phase 3 Study to Begin Shortly Thereafter; KOL Event Set for January 8, 2025 FDA Approves NexoBrid for Pediatric Use $25 Million Financing and €16.25 Million EIC Funding Strengthen Cash Runway to Profitability NexoBrid Product Revenue Meets Expectations; Demand Exceeds Capacity as New Manufacturing Facility Commissioning Underway Conference Call Today, November 26 at 8:30 a.m. Eastern Time YAVNE, Israel, Nov. 26, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a ...

MediWound Ltd. (NASDAQ: MDWD ) is a low-risk but long-term stock buy opportunity, perhaps extending over the next two years. Retail value investors with cash to set aside and patience canI write for retail value investors who cannot afford to lose money but sometimes like to take a risk. I speak for free to community and school groups. I was teaching business, social/political activism, and Middle East politics to international university students in Tel Aviv b4 the pandemic hit. A college in Jerusalem hire ...

YAVNE, Israel, Aug. 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. With this FDA approval, NexoBrid is now authorized for use in the U.S. for all age g ...