Collagenase(Advance Biofactures Corp.)

Initiated VALUE, a global Phase III pivotal trial of EscharEx® for venous leg ulcers Expanded strategic research collaborations with industry leaders, now including Kerecis $20 million in revenue for 2024; $24 million projected for 2025; $44 million in cash as of Year-End 2024 Conference call today, March 19 at 8:30am Eastern Time YAVNE, Israel, March 19, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update. “2024 was a pivotal year for MediWound, marked by strong execution, clinical progress, and strategic collaborations,” said Ofer Gonen, CEO of MediWound. “The initiation of the VALUE Phase III pivotal study is another major milestone, further reinforced by partnerships with industry leaders that highlight EscharEx’s clinical and commercial potential. At the same time, the global adoption of NexoBrid continues to accelerate, solidifying its critical role in modern burn care. With our innovative therapies advancing in wound and burn management and a solid financial foundation, we enter 2025 with momentum and a clear vision to drive meaningful impact for patients worldwide.” 2024 Highlights and Recent Developments: EscharEx® Initiated VALUE, a global pivotal Phase III trial to evaluate EscharEx for the treatment of venous leg ulcers (VLUs), enrolling 216 patients across 40 sites in the U.S. and Europe. An interim sample size assessment will be conducted after 65% of patients complete treatments, enabling adaptive adjustments as needed. This interim analysis is expected in mid-2026.Submitted Phase II study protocol to the U.S. Food and Drug Administration (FDA) for a randomized, head-to-head Phase II study comparing EscharEx to collagenase in VLU patients. This trial, planned for 2025, is designed to support the U.S. Biologics License Application (BLA) submission and strengthen MediWound’s commercialization strategy.Obtained €16.5 million in European Innovation Council (EIC) funding to accelerate the development of EscharEx for treating diabetic foot ulcers (DFUs). A Phase II/III clinical trial is expected to begin in 2026.Expanded strategic research collaborations with leading wound care companies to enhance study execution and improve patient outcomes. In addition to Solventum, Mölnlycke, and MIMEDX, which support the VLU trials, Kerecis (Coloplast subsidiary) has joined as a collaborator in the Phase II/III DFU trial. Kerecis will provide its MariGen Fish-Skin graft as the designated skin substitute during the wound healing phase of the study.Completed a head-to-head comparative analysis of EscharEx vs. SANTYL® from a Phase II trial, demonstrating EscharEx’s superiority in key clinical outcomes.Conducted third-party market research, assessing EscharEx’s total addressable market (TAM) in the U.S. at $2.5 billion. With a projected 22% market share upon approval, peak U.S. sales are expected to reach approximately $725 million. NexoBrid® Completed construction of a new, state-of-the-art GMP-compliant manufacturing facility, with commissioning underway. The facility is expected to reach full operational capacity by the end of 2025, increasing output sixfold. Commercial availability will depend on securing the necessary regulatory approvals.U.S. launch by Vericel continues to gain momentum, with NexoBrid hospital orders increasing by 42% in the fourth quarter compared to the previous quarter.Received FDA approval of NexoBrid for pediatric patients aged newborn through 18 with deep partial-thickness and/or full-thickness thermal burns. NexoBrid is now authorized for use in the U.S. for all age groups, aligning with its indications in the European Union and Japan.Reported positive results from the Expanded Access Protocol (NEXT), reinforcing NexoBrid’s clinical and real-world benefits across 29 burn centers in the U.S. The study included 239 patients (215 adults and 24 children) with deep partial and/or full-thickness thermal burns covering up to 30% of total body surface area (TBSA). Corporate Developments Secured $25 million through a strategic private investment in public equity from a mix of new and existing investors. Mölnlycke Health Care, a global leader in innovative wound care solutions, led the PIPE investment and entered into a collaboration agreement with MediWound. Fourth Quarter 2024 Financial Highlights Revenue: Fourth quarter revenue was $5.8 million, compared to $5.3 million in the fourth quarter of 2023.Gross Profit: Gross profit for the fourth quarter was $0.9 million, representing a gross margin of 15.5%, compared to $0.7 million and a 13.5% gross margin in the same period last year.Expenditures: Research and development expenses were $3.0 million, up from $1.8 million in the fourth quarter of 2023, primarily due to costs associated with the EscharEx VALUE Phase III trial.Selling, general, and administrative expenses totaled $4.0 million, compared to $2.8 million in the prior-year quarter, mainly reflecting increased share-based compensation expenses. Operating Loss: Operating loss was $6.1 million, compared to $3.9 million in the fourth quarter of 2023.Net Loss: Net loss was $3.9 million, or $0.36 per share, compared to a net loss of $1.7 million, or $0.19 per share, in the fourth quarter of 2023.Non-GAAP Adjusted EBITDA: Adjusted EBITDA loss was $4.9 million, compared to a loss of $3.2 million in the same period last year. Full Year 2024 Financial Highlights Revenue: Full-year revenue was $20.2 million, up from $18.7 million in 2023, primarily driven by increased revenue from Vericel and new contracts with the U.S. Department of Defense.Gross Profit: Gross profit for the year was $2.6 million, with a gross margin of 13.0%, compared to $3.6 million and a 19.1% gross margin in 2023. The decline was mainly due to changes in the revenue mix and higher fixed costs associated with scaling production.Expenditures: R&D expenses increased to $8.9 million from $7.5 million in 2023, primarily due to costs related to the EscharEx VALUE Phase III trial.Selling, general, and administrative expenses were $13.1 million, compared to $11.6 million in 2023, mainly reflecting higher share-based compensation costs. Operating Loss: Operating loss was $19.4 million, compared to $15.3 million in 2023.Net Loss: Net loss for 2024 was $30.2 million, or $3.03 per share, compared to $6.7 million, or $0.75 per share, in 2023. The $23.5 million increase was primarily due to financial expenses, mainly from the revaluation of warrants following a 75% rise in the Company’s share price in 2024.Non-GAAP Adjusted EBITDA: Adjusted EBITDA loss was $14.8 million, compared to a loss of $12.3 million in 2023. Balance Sheet Highlights As of December 31, 2024, the Company had cash and cash equivalents and deposits totaling $43.6 million, compared to $42.1 million as of December 31, 2023. During 2024, the Company raised $25 million through a PIPE offering, received $1.2 million from the exercise of Series A warrants, secured a $1.2 million grant from the EIC and fully settled its liability with Teva. The Company used $22.9 million to fund operations in 2024, including $6.8 million allocated to capital expenditures primarily for facility scale-up. Conference Call MediWound management will host a conference call for investors on Wednesday, March 19, 2025, beginning at 8:30 a.m., Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-833-630-1956 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-317-1837 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company’s website. A replay of the call will be available on the Company’s website at www.mediwound.com. Non-IFRS Financial Measures To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company’s performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management. However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company’s operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below. About MediWound MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. 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 burns, 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 $370+ million drug for wound debridement, presenting a unique opportunity for significant market growth. For more information visit www.mediwound.com and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. Contacts: Hani Luxenburg Chief Financial Officer MediWound Ltd.ir@mediwound.com Daniel Ferry Managing Director, LifeSci Advisors 617-430-7576daniel@lifesciadvisors.com Media Contact: Ellie Hanson FINN Partners for MediWoundellie.hanson@finnpartners.com929-588-2008 MediWound, Ltd. Audited Condensed Consolidated Statements of Financial PositionU.S. dollars in thousands Dec 31, 2024 2023 CURRENT ASSETS: Cash and cash equivalents and short-term deposits 43,161 41,708 Trade and other receivable 6,310 5,141 Inventories 2,692 2,846 Total current assets 52,163 49,695 NON-CURRENT ASSETS: Other receivables and long-term restricted bank deposit 439 673 Property, plant and equipment 14,132 9,228 Right of use assets 6,663 6,698 Intangible assets 99 165 Total non-current assets 21,333 16,764 Total assets 73,496 66,459 CURRENT LIABILITIES: Current maturities of long-term liabilities 612 1,410 Warrants 17,092 *7,296 Trade payables and accrued expenses 5,281 5,528 Other payables 3,556 3,891 Total current liabilities 26,541 18,125 NON-CURRENT LIABILITIES: Grants received in advance 736 - Liabilities in respect of IIA grants 8,149 7,677 Liability in respect of TEVA - 2,256 Lease liabilities 6,513 6,350 Severance pay liability, net 404 456 Total non-current liabilities 15,802 16,739 Total liabilities 42,343 34,864 Shareholders' equity 31,153 31,595 Total liabilities & equity 73,496 66,459 * restated with respect to the implementation of the amendments of IAS 1 MediWound, Ltd. Audited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or LossU.S. dollars in thousands (except of share and per share data) Twelve months ended Three months ended Dec 31, Dec 31, 2024 2023 2024 2023 Total Revenues 20,222 18,686 5,840 5,338 Cost of revenues 17,588 15,108 4,937 4,619 Gross profit 2,634 3,578 903 719 Research and development 8,878 7,467 2,986 1,808 Selling and Marketing 4,936 4,844 1,470 1,209 General and administrative 8,202 6,768 2,530 1,583 Other (Income) expenses 18 (211 ) 18 13 Operating loss (19,400 ) (15,290 ) (6,101 ) (3,894 ) Financial income (expenses), net (10,763 ) 8,759 2,211 2,271 Taxes on income (61 ) (185 ) (18 ) (120 ) Net loss (30,224 ) (6,716 ) (3,908 ) (1,743 ) Foreign currency translation adjustments 7 (13 ) 4 (11 ) Total comprehensive loss (30,217 ) (6,729 ) (3,904 ) (1,754 ) Basic and diluted net loss per share (3.03 ) (0.75 ) (0.36 ) (0.19 ) Number of shares used in calculating basic and diluted loss per share 9,959,723 9,013,144 10,790,959 9,219,923 MediWound, Ltd. Audited Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Twelve months ended Three months ended Dec 31, Dec 31, 2024 2023 2024 2023 Audited Unaudited Cash Flows from Operating Activities: Net Loss (30,224 ) (6,716 ) (3,908 ) (1,743 ) Adjustments to reconcile net loss to net cash used in operating activities: Adjustments to profit and loss items: Depreciation and amortization 1,483 1,303 397 346 Share-based compensation 3,138 1,940 822 298 Revaluation of warrants accounted at fair value 10,704 (8,310 ) (1,964 ) (1,605 ) Revaluation of liabilities in respect of IIA grants 752 427 41 (282 ) Revaluation of liabilities in respect of TEVA 770 468 - 111 Financing income and exchange differences of lease liability 487 257 249 463 Increase (decrease) in severance liability, net (30 ) 83 16 3 Other (income) expenses 18 (211 ) 18 13 Financial income, net (2,039 ) (2,231 ) (553 ) (836 ) Un-realized foreign currency loss (gain) 47 189 (27 ) (345 ) 15,330 (6,085 ) (1,001 ) (1,834 ) Changes in assets and liability items: Decrease (increase) in trade receivables (1,141 ) 5,658 (1,426 ) (528 ) Decrease (increase) in inventories 187 (906 ) 348 782 Decrease (increase) in other receivables 120 (894 ) 403 (696 ) Increase (decrease) in trade payables and accrued expenses 406 (594 ) 2,354 1,093 Increase in grants received in advance 1,181 - 1,181 - Increase (decrease) in other payables 517 (928 ) 412 311 1,270 2,336 3,272 962 Net cash used in operating activities (13,624 ) (10,465 ) (1,637 ) (2,615 ) MediWound, Ltd. Audited Condensed Consolidated Statements of Cash Flows U.S. dollars in thousands Twelve months ended Three months ended Dec 31, Dec 31, 2024 2023 2024 2023 Audited Unaudited Cash Flows from Investing Activities: Purchase of property and equipment (6,273 ) (6,464 ) (806 ) (2,209 ) Interest received 2,252 1,947 664 722 Proceeds from (Investment in) short term bank deposits, net (4,376 ) (29,804 ) 4,970 6,515 Net cash provided by (used in) investing activities (8,397 ) (34,321 ) 4,828 5,028 Cash Flows from Financing Activities: Repayment of lease liabilities (928 ) (778 ) (242 ) (204 ) Proceeds from exercise of options 1,210 - - - Proceeds from issuance of shares and warrants, net 22,165 24,909 (271 ) - Repayments of IIA grants, net (219 ) (380 ) - - Repayment of liabilities in respect of TEVA (2,834 ) (834 ) - - Net cash provided by (used in) financing activities 19,394 22,917 (513 ) (204 ) Exchange rate differences on cash and cash equivalent balances (84 ) (160 ) 2 378 Increase (decrease) in cash and cash equivalents (2,711 ) (22,029 ) 2,680 2,587 Balance of cash and cash equivalents at the beginning of the period 11,866 33,895 6,475 9,279 Balance of cash and cash equivalents at the end of the period 9,155 11,866 9,155 11,866 MediWound, Ltd. Adjusted EBITDAU.S. dollars in thousands Twelve months ended Three months ended Dec 31, Dec 31, 2024 2023 2024 2023 Net loss (30,224 ) (6,716 ) (3,908 ) (1,743 ) Adjustments: Financial income (expenses), net (10,763 ) 8,759 2,211 2,271 Other income (expenses), net (18 ) 211 (18 ) (13 ) Taxes on income (61 ) (185 ) (18 ) (120 ) Depreciation and amortization (1,483 ) (1,303 ) (397 ) (346 ) Share-based compensation expenses (3,138 ) (1,940 ) (822 ) (298 ) Total adjustments (15,463 ) 5,542 956 1,494 Adjusted EBITDA (14,761 ) (12,258 ) (4,864 ) (3,237 )

Secured additional R&D collaborations with Solventum and Mölnlycke for optimal trial consistency and patient outcomes Study to support EscharEx® BLA submission and strengthen commercialization strategy YAVNE, Israel, Oct. 10, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today 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. Ofer Gonen, CEO of MediWound, stated: "Building on the consistent positive results from three prior Phase II studies of EscharEx, we are eager to further validate our earlier findings from the head-to-head comparison vs. SANTYL, now on a larger, global scale. We are confident that EscharEx will demonstrate superior efficacy, addressing critical unmet needs in enzymatic debridement for patients with chronic wounds." 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. About EscharEx EscharEx® is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in the advanced stages of clinical development. It is a concentrate of proteolytic enzymes, enriched with bromelain, designed for topical and easy-to-use daily applications. In three previous Phase II trials, EscharEx was shown to be safe and well-tolerated. It demonstrated efficacy in debridement, the promotion of granulation tissue, and the reduction of bioburden and biofilm in various hard-to-heal wounds, effectively preparing the wound bed for healing. MediWound is set to initiate a Phase III study for Venous Leg Ulcers in the second half of 2024. Preparations for a Phase II/III study targeting Diabetic Foot Ulcers are underway. About MediWound MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of rapid and effective biologics that enhance existing standards of care and improve patient experiences while reducing healthcare costs and unnecessary surgeries. MediWound’s first drug, NexoBrid®, is FDA and EMA-approved as an orphan biologic for eschar removal in deep partial-thickness and/or full-thickness thermal burns, significantly reducing the need for surgical interventions. Building on its proprietary enzymatic platform, MediWound is advancing EscharEx®, a promising candidate currently in Phase III development for the debridement of chronic wounds. With distinct advantages over the current $360+ million market leader, EscharEx offers a unique opportunity for significant market expansion. For more information visit www.mediwound.com and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions. Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. MediWound Contacts:Hani LuxenburgChief Financial OfficerMediWound Ltd.ir@mediwound.comDaniel FerryManaging DirectorLifeSci Advisors, LLCdaniel@lifesciadvisors.com Media Contact: Ellie HansonFINN Partners for MediWoundellie.hanson@finnpartners.com+1-929-588-2008