Collagenase(Advance Biofactures Corp.)

Research Published in THE LANCET's eClinicalMedicineEscharEx® Outperforms Non-Surgical Standard of Care in Debridement and Promotion of Healthy Granulation Tissue YAVNE, Israel, July 29, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announces the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eClinicalMedicine, a journal under THE LANCET Discovery Science umbrella. The publication, titled "Once daily Bromelain-based enzymatic debridement of venous leg ulcers versus gel vehicle (placebo) and non-surgical standard of care: a three-arm multicenter, double-blinded, randomized controlled study", reports the results of the study. “The publication in eClinicalMedicine highlights the importance of a safe and effective non-surgical treatment for debridement of chronic wounds, particularly venous leg ulcers (VLUs). Removing non-viable tissue and promoting well-vascularized granulation tissue are essential steps in wound bed preparation, which is crucial for successful wound healing,” stated Dr. John C. Lantis, Chief of Surgery at Mount Sinai West Hospital and principal investigator in the ChronEx study. “The significant superiority of EscharEx over the current non-surgical standard of care in achieving optimal wound bed preparation could dramatically enhance healing outcomes and provide a viable alternative to surgical debridement. This will be a primary focus of the upcoming EscharEx Phase III trial in treating VLUs.” The Phase II ChronEx study was conducted across 20 medical centers and clinics in the United States, Europe and Israel. Patients were randomized in a 3:3:2 ratio to receive daily treatment with EscharEx, a Gel Vehicle (placebo), or non-surgical standard of care (NSSOC), which included SANTYL®, hydrogels, medical grade honey, and non-active dressings. Treatment lasted for up to two weeks (with a maximum of eight daily applications) or until complete debridement was achieved. Following treatment, patients were monitored weekly for an additional 12 weeks. Key study outcomes include: A total of 119 patients were randomized and treated: 46 in the EscharEx arm, 43 in the placebo arm, and 30 in the NSSOC arm.Baseline characteristics of patients and wounds were comparable across all study arms.The study met its primary endpoint: the incidence of complete debridement during the two-week daily treatment was 63.0% for EscharEx compared to 30.2% for placebo (P = 0.004). The incidence of complete debridement for NSSOC during the daily treatment period was 13.3% (P < 0.001).The median time to complete debridement was 9 days for EscharEx vs. 63 days for placebo (P = 0.004) and 59 days for NSSOC (P = 0.016).The incidence of complete cover of the wound bed with healthy granulation tissue during the daily treatment period, was 50.0% for EscharEx compared to 25.6% for placebo (P = 0.01) and 10.0% for NSSOC (P < 0.001).Changes in patient-reported pain, wound size, or wound quality of life (QoL) were comparable between the three treatment arms.The safety profile of EscharEx was comparable to both NSSOC and the placebo. 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 for topical, easy to use daily applications. In several 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, and a Phase II/III study targeting Diabetic Foot Ulcers in the second half of 2025. About MediWound MediWound Ltd. (Nasdaq: MDWD) is the 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 improve existing standards of care and patient experiences, while reducing 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, which can significantly reduce surgical interventions. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline, including the company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for the debridement of chronic wounds, offering significant potential advantages over the dominant $360+ million product and an opportunity to expand the market. For more information visit www.mediwound.com and follow the Company 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 LuxenburgDaniel FerryChief Financial OfficerManaging DirectorMediWound Ltd.LifeSci Advisors, LLCir@mediwound.comdaniel@lifesciadvisors.com Media Contact: Ellie Hanson FINN Partners for MediWound ellie.hanson@finnpartners.com +1-929-588-2008

NexoBrid® interest surges; $5 million in Q1 2024 revenue, with $24 million forecast for the year Manufacturing facility on target for completion by mid-2024 EscharEx® Phase III study to launch 2H 2024 Company set to join Russell 3000® Index Conference call today, May 29 at 8:30am Eastern Time YAVNE, Israel, May 29, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update. "During the first quarter we maintained a laser-focused approach to executing our strategic plan. At the beginning of the year, we set three major goals: accelerate the revenue growth of NexoBrid®, complete construction of the new manufacturing facility by mid-year, and initiate the EscharEx® Phase III clinical trial in the second half of 2024, for which we have established collaborations with the most prominent wound care companies. I am pleased with our progress, as we are on track to achieve all of our targets," said Ofer Gonen, Chief Executive Officer of MediWound. First Quarter 2024 Highlights, Recent Developments and Upcoming Milestones: NexoBrid® U.S. launch by Vericel continued to progress. More than 60 burn centers completed submissions to Pharmacy and Therapeutics (P&T) committees, approximately 40 centers obtained approval, and more than 30 centers have placed initial product orders. Vericel noted significant increases in the number of patients treated with NexoBrid and the number of NexoBrid orders by both burn centers and hospitals.Construction of our new GMP-compliant, state-of-the-art manufacturing facility is on track to be completed by mid-2024, with commissioning set to begin in the third quarter of the year. The facility is expected to be fully operational in 2025, increasing the Company's manufacturing capacity sixfold.Supplemental BLA for pediatric indication accepted for review by the U.S. Food and Drug Administration (FDA). Decision expected in the second half of 2024.Development of the NexoBrid temperature-stable formulation for use as a non-surgical solution for field-care burn treatment for the U.S. Army is progressing as planned. FDA feedback on the development path is expected in the second half of 2024.Enrollment and 12-month follow-up for the Expanded Access Treatment Protocol (NEXT) have been concluded: 239 burn patients have been treated across 29 U.S. centers. Data readout is anticipated in the second half of 2024. EscharEx® Phase III trial remains on track for final protocol submission in the first half of 2024. The global study aims to enroll 216 patients across 40 sites to be treated with either EscharEx or a gel vehicle placebo. An interim assessment will be performed once 67% of participants complete the trial. The study is expected to commence in the second half of 2024.Recent Phase II data, which included comparative analyses demonstrating EscharEx’s superiority over SANTYL®, were presented at three prominent annual wound care conferences: the Wound Healing Society (WHS), the Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA). Corporate Developments Company included in the preliminary list of the Russell 3000® Index, as part of the 2024 Russell indexes annual reconstitution. First Quarter 2024 Financial Highlights Revenue: Revenue for the first quarter of 2024 was $5.0 million, compared to $3.8 million in the first quarter of 2023. The increase is primarily attributed to revenue from Vericel and new contracts with the U.S. Department of Defense (DoD).Gross Profit: Gross profit in the first quarter of 2024 was $0.6 million, representing 12.2% of total revenue, compared to $0.8 million, representing 21.7% of total revenue in the first quarter of 2023. The decrease in gross margin is primarily due to changes in the revenue mix.Expenditures: Research and Development: R&D expenses in the first quarter of 2024 were $1.5 million, compared to $2.1 million in the first quarter of 2023. This decrease is primarily due to the completion of the EscharEx Phase II study.Selling, General, and Administrative: SG&A expenses in the first quarter of 2024 were $2.9 million, compared to $3.1 million in the first quarter of 2023. Operating Results: Operating loss in the first quarter of 2024 was $3.7 million, compared to an operating loss of $4.4 million in the first quarter of 2023.Net Loss: Net loss in the first quarter of 2024 was $9.7 million, or $1.05 per share, compared to a net loss of $3.7 million, or $0.44 per share, in the first quarter of 2023. The increase in net loss is primarily due to financial expenses from revaluation of warrants, amounting to $6.1 million, driven by 40% increase in the Company's share price.Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the first quarter of 2024 was a loss of $2.9 million, compared to a loss of $3.4 million in the first quarter of 2023. Balance Sheet Highlights As of March 31, 2024, the Company had cash and cash equivalents, restricted cash, and deposits totaling $36.0 million, compared to $42.1 million as of December 31, 2023. During the first quarter of 2024, the Company received $0.5 million from the exercise of Series A warrants. The Company utilized $6.5 million to fund its activities in the first quarter of 2024, of which $2.7 million was invested in CAPEX related to the facility scale-up. Conference CallMediWound management will host a conference call for investors on Wednesday, May 29, 2024, 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 the 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 improve existing standards of care and patient experiences, while reducing costs and unnecessary surgeries. MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant potential advantages over the $360 million dominant commercially available product and an opportunity to expand the market. For more information visit www.mediwound.com and follow the Company 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; risks related to our contracts with BARDA; 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. 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 HansonFINN Partners for MediWoundellie.hanson@finnpartners.com929-588-2008 MediWound, Ltd. Unaudited Condensed Consolidated Statements of Financial PositionU.S. dollars in thousands March 31, December 31, 2024 2023 2023 CURRENT ASSETS: Cash and cash equivalents and short-term deposits 35,568 57,204 41,708 Trade and other receivable 5,317 3,531 5,141 Inventories 3,311 2,536 2,846 Total current assets 44,196 63,271 49,695 Non-current assets Trade and other receivables 238 305 233 Long-term restricted bank deposits 446 - 440 Property, plant and equipment, net 10,422 3,724 9,228 Right of use assets, net 6,926 1,151 6,698 Intangible assets, net 149 215 165 Total non-current assets 18,181 5,395 16,764 Total assets 62,377 68,666 66,459 CURRENT LIABILITIES: Current maturities of long-term liabilities 1,541 2,139 1,410 Warrants, net 13,065 14,674 7,296 Trade payables and accrued expenses 4,246 3,403 5,528 Other payables 3,486 3,722 3,891 Total current liabilities 22,338 23,938 18,125 :NON-CURRENT LIABILITIES Liabilities in respect of IIA grants 7,780 7,580 7,677 Liabilities in respect of TEVA 2,111 2,660 2,256 Lease liabilities 6,467 743 6,350 Severance pay liability, net 482 445 456 Total non-current liabilities 16,840 11,428 16,739 Shareholders' equity 23,199 33,300 31,595 Total liabilities & shareholder equity 62,377 68,666 66,459 MediWound, Ltd. Unaudited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss U.S. dollars in thousands (except of share and per share data) Three months ended March 31, Year endedDecember 31, 2024 2023 2023 Total Revenues 4,964 3,799 18,686 Cost of revenues 4,357 2,973 15,108 Gross profit 607 826 3,578 Research and development 1,470 2,102 7,467 Selling and Marketing 1,179 1,106 4,844 General and administrative 1,692 1,982 6,768 Other Income - - (211) Operating loss (3,734) (4,364) (15,290) Financial income (expenses), net (5,971) 676 8,759 Taxes on income (24) (5) (185) Net loss (9,729) (3,693) (6,716) Foreign currency translation adjustments 8 (9) (13) Total comprehensive loss (9,721) (3,702) (6,729) Basic and diluted loss per share: Net loss per share (1.05) (0.44) (0.75) Weighted average number of ordinary shares 9,234,104 8,388,109 9,013,144 MediWound, Ltd.Unaudited Condensed Consolidated Statements of Cash Flows U.S. dollars in thousands Three months endedMarch 31, Year EndedDecember 31, 2024 2023 2023 Cash Flows from Operating Activities: Net loss (9,729) (3,693) (6,716) Adjustments to reconcile net loss to net cash used in operating activities: Adjustments to profit and loss items: Depreciation and amortization 368 303 1,303 Share-based compensation 512 619 1,940 Revaluation of warrants accounted at fair value 6,080 (932) (8,310) Revaluation of liabilities in respect of IIA grants 233 259 427 Revaluation of liabilities in respect of TEVA 107 122 468 Financing income and exchange differences of lease liability 28 (13) 257 Increase in severance liability, net 35 77 83 Other income - - (211) Financial income, net (513) (246) (2,231) Un-realized foreign currency loss 67 345 189 6,917 534 (6,085) Changes in asset and liability items: Decrease (Increase) in trade receivables (123) 6,822 5,658 Increase in inventories (448) (583) (906) Increase in other receivables (115) (313) (894) Decrease in trade payables and accrued expenses (1,370) (1,948) (594) Increase (decrease) in other payables 260 (167) (928) (1,796) 3,811 2,336 Net cash provided by (used in) operating activities (4,608) 652 (10,465) Unaudited Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Three months endedMarch 31, Year EndedDecember 31, 2024 2023 2023 Cash Flows from Investment Activities: Purchase of property and equipment (1,259) (1,505) (6,464) Interest received 605 302 1,947 Investment in short term bank deposits, net (1,130) (6,240) (29,804) Net cash used in investing activities (1,784) (7,443) (34,321) Cash Flows from Financing Activities: Repayment of lease liabilities (244) (177) (778) Proceeds from issuance of shares and warrants, and exercise of warrants, net 499 25,157 24,909 Repayments of IIA grants, net (120) (310) (380) Repayment of liabilities in respect of TEVA (834) (417) (834) Net cash provided by (used in) financing activities (699) 24,253 22,917 Exchange rate differences on cash and cash equivalent balances (89) (337) (160) Increase (decrease) in cash and cash equivalents (7,180) 17,125 (22,029) Balance of cash and cash equivalents at the beginning of the period 11,866 33,895 33,895 Balance of cash and cash equivalents at the end of the period 4,686 51,020 11,866 MediWound Ltd.ADJUSTED EBITDA U.S. dollars in thousands Three months endedMarch 31, Year endedDecember 31, 2024 2023 2023 Net loss (9,729) (3,693) (6,716) Adjustments: Financial income (expenses), net (5,971) 676 8,759 Other Income, net - - 211 Taxes on income (24) (5) (185) Depreciation and amortization (368) (303) (1,303) Share-based compensation expenses (512) (619) (1,940) Total adjustments (6,875) (251) 5,542 Adjusted EBITDA (2,854) (3,442) (12,258)