EscharEx

Approval Helps Solidify NexoBrid’s Position in the U.S. as a Safe and Effective Non-Surgical Burn Treatment for All AgesYAVNE, 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 groups, aligning with its approvals in the European Union and Japan. “Today's announcement marks a significant milestone in our mission to improve burn care with NexoBrid,” said Ofer Gonen, Chief Executive Officer of MediWound. “Pediatric burn victims represent over 30% of the total burn population, and the current surgical standard of care can be extremely traumatic for both patients and their families. Since NexoBrid's initial approval, we have been dedicated to expanding its use to children, reflecting our long-term commitment to revolutionizing burn care.” The submission was supported by the results of a global Phase III clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase III and Phase II studies conducted during the clinical development of NexoBrid. Of note, the CIDS trial was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. About NexoBrid® NexoBrid® is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid® is approved in over 40 countries, including the United States, European Union, and Japan. It has been designated as an orphan biologic drug in all these territories. NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States. 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 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, 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

Completed Construction of New NexoBrid® Manufacturing Facility €16.25 Million EIC Funding Expedites EscharEx® Development for Diabetic Foot Ulcers, Significantly Expanding the Addressable Market; Phase III Study for Venous Leg Ulcers to Begin in H2 2024 $25 Million Strategic Investment Led by Mölnlycke Health Care Conference Call Today, August 14 at 8:30am Eastern Time YAVNE, Israel, Aug. 14, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the second quarter ended June 30, 2024, and provided a corporate update. “This has been another strong quarter for MediWound as we continue to successfully execute our strategic plan,” said Ofer Gonen, Chief Executive Officer of MediWound. “We have completed construction of our new GMP-compliant, state-of-the-art manufacturing facility for NexoBrid® addressing the growing global demand for this product. We are well on track to achieving our two remaining key goals: accelerating NexoBrid's revenue growth and initiating the Phase III clinical trial for EscharEx. In addition to these strategic milestones, we secured €16.25 million in funding from the European Innovation Council (EIC) to expand EscharEx’s indications to include diabetic foot ulcers, significantly increasing the product’s total addressable market. Furthermore, we raised $25 million in financing led by Mölnlycke Health Care, an industry leader, demonstrating confidence in our technology and further strengthening our financial position.” Second Quarter 2024 Highlights, Recent Developments and Upcoming Milestones: NexoBrid Construction of our new, state-of-the-art GMP-compliant manufacturing facility is complete. Commissioning will begin soon, aiming for full operational capacity in 2025. This expansion will increase manufacturing capacity sixfold.U.S. launch by Vericel continues to build momentum. Approximately 70 burn centers have completed submissions to Pharmacy and Therapeutics (P&T) committees, with 40+ centers already obtaining approval, and nearly all of those placing initial product orders. Vericel reported a notable increase in hospital orders and the number of patients treated, driving a revenue growth of 76% over prior quarter.Results from the U.S. NexoBrid Expanded Access Protocol (NEXT) were positive and aligned with the findings from Phase III studies. Conducted at 29 burn centers across the U.S. with 239 patients enrolled, and designed to ensure continuous availability until commercialization, NEXT reaffirmed NexoBrid's proven safety and efficacy in eschar removal, significantly reducing the need for surgical procedures in burn patients.U.S. Food and Drug Administration (FDA) approval of the pediatric indication is expected in the third quarter of 2024. EscharEx Phase III study of EscharEx for treating venous leg ulcers (VLUs) is scheduled to start in the second half of 2024, as planned.€16.25 million in funding from the EIC will accelerate the clinical development of EscharEx for treating diabetic foot ulcers (DFUs). This will expedite MediWound's DFU program, and its associated revenue projections by four years. DFUs are more prevalent than VLUs, with a higher percentage of them requiring debridement. Preparations for the DFU Phase II/III study are currently underway.Results of EscharEx Phase II ChronEx study were published in THE LANCET’s eClinicalMedicine journal. EscharEx outperformed non-surgical SOC in debridement and promotion of healthy granulation tissue. Corporate Developments Secured $25 million in a strategic private investment in public equity with several new and existing investors. Mölnlycke Health Care, a global leader in innovative wound care solutions, led the PIPE and has entered into a collaboration agreement with MediWound.Company included in the Russell 3000® Index, as part of the 2024 Russell indexes annual reconstitution. Second Quarter 2024 Financial Highlights Revenue: Revenue for the second quarter of 2024 was $5.1 million, up from $4.8 million in the same period of 2023. The increase is primarily attributed to revenue from Vericel.Gross Profit: Gross profit for the second quarter of 2024 was $0.4 million, representing 9% of total revenue, compared to $1.1 million, representing 24% of total revenue in the second quarter of 2023. The decrease in gross margin is mainly due to changes in the revenue mix and nonrecurring production costs.Expenditures: Research and Development: R&D expenses for the second quarter of 2024 were $1.9 million, compared to $2.0 million in the same period of 2023. Selling, General, and Administrative: SG&A expenses for the second quarter of 2024 were $3.0 million, compared to $3.1 million in the second quarter of 2023. Operating Results: Operating loss for the second quarter of 2024 was $4.5 million, compared to an operating loss of $4.0 million in the second quarter of 2023.Net Profit (Loss): Net loss for the second quarter of 2024 was $6.3 million, or $0.68 per share, compared to a net profit of $0.9 million, or $0.10 per share, in the second quarter of 2023. This change is primarily due to financial expenses driven by the revaluation of warrants.Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the second quarter of 2024 was a loss of $3.4 million, compared to a loss of $3.0 million in the same period of 2023. Year-to-Date 2024 Financial Highlights Revenue: Total revenues for the first half of 2024 were $10.0 million, up from $8.6 million in the first half of 2023. The increase is mainly attributed to revenue from Vericel and new contracts with the U.S. Department of Defense (DoD).Gross Profit: Gross profit for the first half of 2024 was $1.1 million, or 11% of total revenue, compared to $2.0 million, or 23% of total revenue, in the first half of 2023.Expenditures: Research and Development: R&D expenses for the first half of 2024 were $3.4 million, compared to $4.1 million in the first half of 2023. This decrease is primarily due to the completion of the EscharEx Phase II study.Selling, General, and Administrative: SG&A expenses for the first half of 2024 were $5.9 million, down from $6.2 million in the first half of 2023. Operating Results: Operating loss for the first half of 2024 was $8.2 million, compared to an operating loss of $8.4 million in the same period of 2023. Net Loss: Net loss for the first half of 2024 was $16.0 million, or $1.73 per share, compared to a net loss of $2.8 million, or $0.32 per share, in the first half of 2023. The increase in net loss is primarily attributable to financial expenses from the revaluation of warrants, which amounted to $8 million, driven by a 53% increase in the Company’s share price.Adjusted EBITDA: Adjusted EBITDA for the first half of 2024 was a loss of $6.2 million, compared to a loss of $6.4 million in the first half of 2023. Balance Sheet Highlights As of June 30, 2024, the Company had cash and cash equivalents, restricted cash, and deposits totaling $29.7 million, compared to $42.1 million as of December 31, 2023. In the first half of 2024, the Company received $0.6 million from the exercise of Series A warrants. The Company utilized $12.9 million to fund its activities in the first half of 2024, including $4.3 million allocated to CAPEX primarily for facility scale-up. On July 15, the Company successfully raised $25 million through a PIPE offering. Following the PIPE, the issued and outstanding shares of NIS 0.07 par value were 10,786,423. Conference Call MediWound management will host a conference call for investors on Wednesday, August 14, 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 Daniel FerryChief Financial OfficerManaging Director, LifeSci AdvisorsMediWound Ltd.617-430-7576ir@mediwound.comdaniel@lifesciadvisors.com Media Contact: Ellie Hanson FINN Partners for MediWound ellie.hanson@finnpartners.com 929-588-2008 MediWound, Ltd. Unaudited Condensed Consolidated Statements of Financial PositionU.S. dollars in thousands June 30, December 31, 2024 2023 2023CURRENT ASSTS: Cash and cash equivalents and short-term deposits 29,215 51,122 41,708Trade and other receivable 4,888 3,818 5,141Inventories 3,210 3,113 2,846Total current assets 37,313 58,053 49,695 Non-current assets Trade and other receivables 238 277 233Long-term restricted bank deposits 453 - 440Property, plant and equipment, net 12,308 4,705 9,228Right of use assets, net 6,852 1,133 6,698Intangible assets, net 132 198 165Total non-current assets 19,983 6,313 16,764 Total assets 57,296 64,366 66,459 CURRENT LIABILITIES: Current maturities of long-term liabilities 1,496 1,961 1,410Warrants, net 14,902 9,683 7,296Trade payables and accrued expenses 2,745 3,531 5,528Other payables 3,468 2,817 3,891Total current liabilities 22,611 17,992 18,125 :NON- CURRENT LIABILITIES Liabilities in respect of IIA grants 8,009 7,806 7,677Liabilities in respect of TEVA 1,962 2,529 2,256Lease liability 6,355 677 6,350Severance pay liability, net 490 433 456Total non-current liabilities 16,816 11,445 16,739 Shareholders' equity 17,869 34,929 31,595Total liabilities & shareholder equity 57,296 64,366 66,459 MediWound, Ltd. Unaudited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or LossU.S. dollars in thousands (except of share and per share data) Six months ended Three months ended Year ended June 30, June 30, December 31, 2024 2023 2024 2023 2023Total Revenues10,027 8,572 5,063 4,773 18,686Cost of revenues8,973 6,609 4,616 3,636 15,108Gross profit1,054 1,963 447 1,137 3,578 Research and development3,368 4,126 1,898 2,024 7,467Selling and Marketing2,403 2,438 1,224 1,332 4,844General and administrative3,501 3,770 1,809 1,788 6,768Other Income- - - - (211)Total operating expenses9,272 10,334 4,931 5,144 18,868 Operating loss(8,218) (8,371) (4,484) (4,007) (15,290) Financial income (expenses), net(7,794) 5,611 (1,823) 4,935 8,759Taxes on income(22) (17) 2 (12) (185)Net profit (loss)(16,034) (2,777) (6,305) 916 (6,716)Foreign currency translation adjustments10 (9) 2 - (13)Total comprehensive profit (loss)(16,024) (2,786) (6,303) 916 (6,729) Basic and diluted loss per share: Net profit (loss) per share(1.73) (0.32) (0.68) 0.1 (0.75) Weighted average number of ordinary shares9,256,862 8,803,065 9,279,370 9,208,902 9,013,144 MediWound, Ltd. Unaudited Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2024 2023 2024 2023 2023Cash Flows from Operating Activities: Net profit (loss) (16,034) (2,777) (6,305) 916 (6,716)Adjustments to reconcile net profit (loss) to net cash used in operating activities: Adjustments to profit and loss items: Depreciation and amortization 725 618 357 315 1,303Share-based compensation 1,270 1,331 758 712 1,940Revaluation of warrants accounted at fair value 8,007 (5,923) 1,927 (4,990) (8,310)Revaluation of liabilities in respect of IIA grants 470 492 237 233 427Revaluation of liabilities in respect of TEVA 206 241 99 119 468Financing income and exchange differences of lease liability 17 (22) (11) (9) 257Increase in severance liability, net 48 67 13 (10) 83Other income - - - - (211)Financial income, net (918) (1,005) (405) (759) (2,231)Un-realized foreign currency loss 78 466 11 120 189 9,903 (3,735) 2,986 (4,269) (6,085)Changes in asset and liability items: Decrease (increase) in trade receivables 753 6,115 876 (707) 5,658Decrease (increase) in inventories (345) (1,162) 103 (579) (906)Decrease (increase) in other receivables (574) 122 (459) 435 (894)Increase (decrease) in trade payables and accrued expenses (1,900) (1,636) (530) 312 (594)Decrease in other payables (34) (1,526) (294) (1,359) (928) (2,100) 1,913 (304) (1,898) 2,336Net cash used in operating activities (8,231) (4,599) (3,623) (5,251) (10,465) Unaudited Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2024 2023 2024 2023 2023Cash Flows from Investment Activities: Purchase of property and equipment(4,275) (2,570) (3,016) (1,065) (6,464)Interest received1,127 879 522 577 1,947Proceeds from (investment in) short term bank deposits, net4,209 (31,830) 5,339 (25,590) (29,804)Net cash provided by (used in) investing activities1,061 (33,521) 2,845 (26,078) (34,321) Cash Flows from Financing Activities: Repayment of lease liabilities(458) (334) (214) (157) (778)Proceeds from exercise of warrants610 (*) 111 (*) -Proceeds from issuance of shares and warrants, net- 24,909 - (248) 24,909Repayments 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(802) 23,848 (103) (405) 22,917 Exchange rate differences on cash and cash equivalent balances(104) (457) (15) (120) (160)Decrease in cash and cash equivalents(8,076) (14,729) (896) (31,854) (22,029) Balance of cash and cash equivalents at the beginning of the period11,866 33,895 4,686 51,020 33,895Balance of cash and cash equivalents at the end of the period3,790 19,166 3,790 19,166 11,866 MediWound Ltd.Adjusted EBITDAU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2024 2023 2024 2023 2023Net profit (loss)(16,034) (2,777) (6,305) 916 (6,716)Adjustments: Financial income (expenses), net(7,794) 5,611 (1,823) 4,935 8,759Other Income, net- - - - 211Taxes on income(22) (17) 2 (12) (185)Depreciation and amortization (725) (618) (357) (315) (1,303)Share-based compensation expenses(1,270) (1,331) (758) (712) (1,940)Total adjustments (9,811) 3,645 (2,936) 3,896 5,542Adjusted EBITDA (6,223) (6,422) (3,369) (2,980) (12,258)