MediWound Limited (MDWD)

MediWound Announces Publication of Phase II EscharEx® Data Demonstrating Superiority Over Collagenase in Venous Leg Ulcers

Great news!!!

Rosalind Advisors, Inc. Increases Stake in MediWound Ltd

https://finance.yahoo.com/news/rosalind-advisors-inc-increases-stake-230107196.html

Thu, October 24, 2024 at 2:01 AM

On September 30, 2024, Rosalind Advisors, Inc. (Trades, Portfolio), a prominent investment firm, expanded its portfolio by acquiring an additional 114,560 shares of MediWound Ltd (NASDAQ:MDWD). This transaction increased the firm's total holdings in the company to 628,050 shares, marking a significant enhancement of its investment in the biotechnology sector. The shares were purchased at a price of $18.06 each, reflecting a strategic move by the firm to bolster its position in MediWound Ltd.

MediWound Announces Phase II Head-to-Head Study Evaluating EscharEx® vs. Collagenase in Patients with Venous Leg Ulcers

https://finance.yahoo.com/news/mediwound-announces-phase-ii-head-110000332.html

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.

MediWound Announces U.S. Food and Drug Administration Approval of NexoBrid® for the Treatment of Pediatric Patients with Severe Thermal Burns

https://finance.yahoo.com/news/mediwound-announces-u-food-drug-201500706.html

Approval Helps Solidify NexoBrid’s Position in the U.S. as a Safe and Effective Non-Surgical Burn Treatment for All Ages

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 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.

MediWound Reports Second Quarter 2024 Financial Results and Provides Company Update

https://finance.yahoo.com/news/mediwound-reports-second-quarter-2024-110000628.html

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.

MediWound Announces Positive Results from the U.S. NexoBrid® Expanded Access Protocol (NEXT)

https://finance.yahoo.com/news/mediwound-announces-positive-results-u-113000398.html

.
NEXT Confirms NexoBrid's Proven Safety and Efficacy in Eschar Removal, Significantly Reducing Surgical Procedures for Burn Patients

YAVNE, Israel, Aug. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid® in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated the accumulation of real-world safety and clinical data for NexoBrid.

Jeremy Goverman, MD, FACS, Associate Professor of Surgery at Harvard Medical School, commented, “The NEXT results reaffirm the significant benefits of NexoBrid in managing severe burns. This enzymatic debridement agent accelerates the debridement process and reduces the need for surgical interventions, ultimately enhancing patient outcomes. The findings from NEXT are consistent with data from the DETECT and CIDS Phase III trials, reinforcing the critical role that NexoBrid should play in standard burn care protocols.”

NEXT, an open-label, single-arm treatment protocol was conducted at 29 burn centers across the U.S. 239 patients, including 215 adults and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of the total body surface area (TBSA) were treated with NexoBrid.

Key Results of the NEXT Protocol Include:

Efficacy (findings were consistent with Phase III studies results):

94.9% of adults and 100% of children achieved complete debridement.

Only 4.2% of adults required surgical excision for eschar removal after NexoBrid treatment, and none in the pediatric group.

The mean (± SD) percent of wound area surgically excised for adults was 3.6% (±18.33), and 0% for children.

The time to complete eschar removal was less than one day for both adults and children.

Healing and Hospitalization:

The median time to wound closure was 22 days (95% CI: 22, 23) for adults and 28 days (95% CI: 18, 32) for children.

The median time of hospitalization duration was 10 days (95% CI: 8, 11) for adults and 10 days (95% CI: 5, 14) for children.

Safety: The safety data was consistent with the established safety profile of NexoBrid, and no new safety concerns were identified by the Data Safety and Monitoring Board (DSMB).

Benefit-Risk Ratio: The overall benefit-to-risk ratio of NexoBrid treatment remains favorable.

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 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.

MediWound to Report Second Quarter 2024 Financial Results

https://finance.yahoo.com/news/mediwound-report-second-quarter-2024-120000328.html

Conference Call and Webcast Scheduled for Wednesday, August 14th at 8:30 am Eastern Time

YAVNE, Israel, Aug. 02, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the second quarter ended June 30, 2024 on Wednesday, August 14, 2024.

Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions.

Dial-in and call details are as follows:

Conference Call & Webcast Details

Toll-Free:

1-833-630-1956

Israel:

1-80-921-2373

International:

1-412-317-1837

Webcast:

Click HERE

To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay on the Investors section of the MediWound website.

NexoBrid Revenue Growth of 76% Over Prior Quarter
NexoBrid launch progressing with approximately 70 Pharmacy and Therapeutics (P&T) committee submissions, more than 40 burn centers obtaining approval and approximately 40 centers placing initial orders

FDA approval of pediatric indication for NexoBrid expected in the third quarter of 2024

All above from
https://finance.yahoo.com/news/vericel-reports-second-quarter-2024-115500147.html

MediWound reinforces wound therapy EscharEx data ahead of Phase III trial

https://finance.yahoo.com/news/mediwound-reinforces-wound-therapy-escharex-111308121.html

Phalguni Deswal

MediWound has published Phase II trial data showing that its wound debridement therapy, EscharEx, is superior at treating venous leg ulcers than other non-surgical standard-of-care solutions.

The Phase II ChronicEx trial (NCT03588130) data was published in the eClinicalMedicine journal, part of the Lancet Discovery Science. The company aims to start a Phase III trial evaluating EscharEx as a treatment for venous leg ulcers in the second half of this year.

“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, 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 venous leg ulcers.”

The ChronEx study enrolled 119 patients, who received either EscharEx, a placebo gel vehicle or a non-surgical standard of care treatment such as Collagenase Santyl ointment hydrogels, medical grade honey, and non-active dressings. The trial met its primary endpoint with 63% of participants who received EscharEx achieving complete debridement, compared to 30.2% and 13.3% in the placebo and non-surgical standard of care treatments respectively.

The median time to complete debridement was nine days for EscharEx, compared to 63 days for placebo and 59 days for non-surgical standard-of-care treatments. Furthermore, the incidence of a complete cover of the wound bed with healthy granulation tissue during the daily treatment period was 50.0% for EscharEx compared to 25.6% and 10.0% for placebo and non-surgical standard-of-care treatments respectively.

EscharEx is a bioactive therapy that consists of a concentration of proteolytic enzymes. It is being developed for debridement of chronic and other hard-to-heal wounds. MediWound also plans to investigate EscharEx in another chronic wound condition, diabetic foot ulcers in the second half of 2025.

Another product in MediWound’s portfolio is NexoBrid (anacaulase-bcdb) treatment. It was approved by the US Food and Drug Administration (FDA) to eliminate eschar in adults with deep partial-thickness and/or full-thickness thermal burns in January.

"MediWound reinforces wound therapy EscharEx data ahead of Phase III trial" was originally created and published by Medical Device Network, a GlobalData owned brand.

MediWound Announces Publication of the EscharEx® Phase II ChronEx Study Results for Venous Leg Ulcers

https://finance.yahoo.com/news/mediwound-announces-publication-escharex-phase-120000233.html

Research Published in THE LANCET's eClinicalMedicine

EscharEx® 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.

What appeals to them is not only NexoBrid which is a complimentary
product to theirs, but EscharEx® the bioactive, multimodal debridement
therapy for the treatment of chronic and other hard-to-heal wounds.

In other words, Mölnlycke is buying into a potential product which
in case of approval is not a step forward for them, but a major
development for the company.

I wonder what their ultimate end goal is, besides keeping MDWD on a very short leash and buying while the common shares are still relatively inexpensive.
Thank you very much for digging up this info.

Collaboration and Rights Agreement

Form SC 13D

In connection with the 2024 Offering, Mölnlycke and the Issuer entered into a Collaboration and Rights Agreement, dated July 15, 2024 (the “Collaboration Agreement”), whereby the Issuer shall be able to benefit from Mölnlycke’s comprehensive global expertise in advanced wound care. Accordingly, if requested by the Issuer, Mölnlycke shall provide the Issuer with commercial insights, clinical and regulatory experience, and educational resources.

Besides the parties’ collaboration in that manner, the Collaboration Agreement also grants Mölnlycke certain specific rights, including: (a) attendance/discussion rights with the Research & Development Committee of the Issuer’s board of directors (the “Board”) in a non-voting, observer capacity, and the Chief Executive Officer of Mölnlycke and the Executive Vice President, Wound Care of Mölnlycke will be invited to attend quarterly meetings with the Issuer’s Chief Executive Officer and the Issuer’s Chairman of the Board; (b) strategic evaluation rights related to EscharEx®; (c) a right of first participation in the process for an acquisition of the Issuer; provided, however, if the Issuer enters into, and the Board recommends in favor of, a definitive agreement with any third party with respect to an acquisition, Mölnlycke has agreed to vote the Ordinary Shares held by it in favor of such acquisition; (d) shareholdings exclusivity, whereby the Issuer may not sell or issue any equity securities to any entity having a significant commercial business in the field of wound-care until the earlier of (i) the two-year anniversary of the closing of the 2024 Offering and (ii) the termination of the agreement; and (e) customary preemptive rights to maintain its ownership percentage in the Issuer, subject to customary exceptions, until the earlier of (i) the two-year anniversary of the closing of the 2024 Offering and (ii) the termination of the agreement.

The Collaboration Agreement also contains stand-still provisions that limit Mölnlycke’s ownership to no more than 9.99% of the Issuer’s issued and outstanding Ordinary Shares during the duration of the agreement, including pursuant to any voting or other agreement.

The foregoing descriptions of the Share Purchase Agreement, the Registration Rights Agreement and the Collaboration Agreement do not purport to be complete and are qualified in their entirety by reference to the forms thereof filed as exhibits to this Schedule 13D, which exhibits are hereby incorporated by reference into this Item 4.

Mölnlycke acquired the Ordinary Shares for strategic investment purposes and to strengthen the partnership and collaboration between the parties. Depending on their review and evaluation of the business and prospects of the Issuer and the price level of the securities of the Issuer, or such other factors as they may deem relevant, the Reporting Persons may acquire additional securities of the Issuer; may sell all or any part of its securities of the Issuer in the open market, in privately negotiated transactions or in sales registered or exempt from registration under the Securities Act of 1933, as amended; may transfer shares to affiliated entities or may engage in any combination of the foregoing. Subject to applicable law and contractual limitations, the Reporting Persons may enter into derivative transactions, margin loans, hedging transactions or alternative structures with respect to the securities of the Issuer. Any open market or privately negotiated purchases, sales, distributions or other transactions may be made at any time without additional prior notice. Any alternative that the Reporting Persons may pursue will depend upon a variety of factors, including without limitation, current and anticipated future trading prices of the securities of the Issuer, the financial condition, results of operations and prospects of the Issuer and general economic, financial market and industry conditions, other investment and business opportunities available to the Reporting Persons, general stock market and economic conditions, tax considerations and other factors.

Other than as described above, Reporting Persons do not currently have any plans or proposals that relate to, or would result in, any of the matters listed in Items 4(a)–(j) of Schedule 13D, although, depending on the factors discussed herein, Reporting Persons may change their purpose or formulate different plans or proposals with respect thereto at any time.

MediWound Announces €16.25 Million Funding from the European Innovation Council Accelerator Program

https://finance.yahoo.com/news/mediwound-announces-16-25-million-113000453.html


Funds to be used for clinical development of EscharEx® to treat diabetic foot ulcers (DFUs)

Award advances MediWound’s DFU program and its future revenues four years ahead of original schedule

YAVNE, Israel, July 16, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today it has been selected to receive €16.25 million in blended funding from the European Innovation Council (EIC) through its accelerator program. The funding will significantly advance the Company’s EscharEx development program for patients with diabetic foot ulcers (DFUs). Pending FDA and EMA approval, the funding will enable the Company to expedite the market introduction of this innovative biologic by four years, well ahead of MediWound’s original schedule.

The EIC Accelerator offers grants and equity investments to support innovative, game-changing products. In addition to financial support, selected projects benefit from a range of business acceleration services that provide access to global experts, businesses, investors and ecosystem players. The funding package includes a €2.5 million grant and an investment, with terms to be finalized between the Company and the EIC.

"We are honored to be selected for this prestigious and highly competitive program," stated Ofer Gonen, Chief Executive Officer of MediWound. "The EIC's support recognizes EscharEx's potential to profoundly impact patients, especially those living with the significant challenges of DFUs. This funding will enable MediWound to develop EscharEx for DFU in parallel with our advanced program for treating venous leg ulcers (VLUs), substantially increasing the overall market."

With 70% of DFU patients requiring debridement, EscharEx addresses a staggering market of up to 34 million diabetic patients (US and Europe) who are at risk of developing a DFU in their lifetime. If not properly treated, DFUs can lead to serious complications including amputations, infections and death. Accelerating this program will have a revolutionary impact on the future DFU treatment for the millions of patients in this underserved population.

For more information about the EIC Accelerator, visit https://eic.ec.europa.eu/eic-funding-opportunities/eic-accelerator_en.

Funnily enough, share price has not
declined too steeply:
20.41 -0.75 (-3.54%)
At close: July 15 at 4:00 PM EDT

FORM 6-K

Amendment to Settlement Agreement with Teva

On July 15, 2024, MediWound Ltd. (the “Company”) and Teva Pharmaceutical Industries Ltd. (“Teva”) entered into Amendment No. 2 (the “Amendment”) to the settlement agreement and mutual general release, dated March 24, 2019, as previously amended by Amendment No. 1, dated December 13, 2020, by and between the Company and Teva (the “Agreement”). Under the terms of the Amendment, the Company will prepay Teva US$4 million as the final payment due from the Company under the Agreement, with 50% of such prepayment in cash and 50% in the form of ordinary shares of the Company to be issued by the Company to Teva, all in accordance with the terms and timeframe specified in the Amendment.

Will not be sold soon: Mediwound raises 25 million dollars
The fundraising was led by the Swedish Molenlik and at a discount of 19% on the share price this morning
• The fundraising currently postpones a possible purchase of the company, but the agreement does not block the possibility of its existence in the future •
Mediwoundd is the most significant holding of Clal Biotechnology whose stock has increased by 23% thanks to Mediwound in the past year.

Mölnlycke® Health Care announces US $15m investment in next-generation enzymatic therapeutics company MediWound Ltd

https://finance.yahoo.com/news/m-lnlycke-health-care-announces-113800644.html

GOTHENBURG, Sweden, July 15, 2024 /PRNewswire/ -- Mölnlycke Health Care, a world-leading MedTech company specialising in solutions for wound care and surgical procedures, announced today an investment of US $15m in MediWound Ltd. (Nasdaq: MDWD) (MediWound) through a definitive share purchase agreement in a private investment in public equity (PIPE). MediWound, a global leader in next-generation enzymatic therapeutics focused on non-surgical wound debridement, has a vision to improve the existing standards of care and patient experiences, while reducing costs and unnecessary surgeries.

Debridement is a standard of care step to prepare the wound bed for healing and can help in the management of infection. It involves the removal of dead or devitalised tissue from a wound.

"We are very excited to make this strategic investment in MediWound. It aligns with our strategy to bring radical innovations into the wound care space and provide alternative solutions to the more traditional debridement options to improve clinical outcomes and patient experience," said Zlatko Rihter, CEO of Mölnlycke. "This investment will support Mölnlycke's Wound Care mission to 'help free patients from the burden of wounds' and I look forward to this partnership."

Mölnlycke and MediWound have also entered into a collaboration agreement to strengthen their partnership. Under the key terms of this agreement, Mölnlycke is granted specific rights, including having a representative attend meetings of MediWound's R&D Committee and will also be able to participate in potential strategic partnership discussions and M&A processes under certain circumstances.

"We are delighted to have Mölnlycke's support. This substantial investment will empower us to strengthen our strategic plans, creating significant long-term value for our stakeholders and help to improve standards of care for patients" said Ofer Gonen, CEO of MediWound.

For more information, please conatct:
Jennifer Doak
Global Communications Director Wound Care
Email: jennifer.doak@molnlycke.com
Phone: +1 678 206 6179
Ellie Hanson
FINN Partners for MediWound
Email: ellie.hanson@finnpartners.com
Phone: +1 929 588 2008

This information was brought to you by Cision http://news.cision.com.

https://news.cision.com/molnlycke/r/molnlycke--health-care-announces-us--15m-investment-in-next-generation-enzymatic-therapeutics-compan,c4015001

MediWound Announces $25 Million Strategic Private Placement Financing

https://finance.yahoo.com/news/mediwound-announces-25-million-strategic-110000594.html

Mölnlycke Health Care, a global leader in innovative wound care solutions, leads the PIPE with a $15 million investment

YAVNE, Israel, July 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the world leader in next-generation enzymatic therapeutics for tissue repair, today announced it has entered into a definitive share purchase agreement with several new and existing investors, including Mölnlycke Health Care ("Mölnlycke"), a world-leading MedTech company specializing in solutions for wound care and surgical procedures.

The agreement includes the sale and purchase of 1,453,488 shares of the Company’s ordinary shares, each with a par value NIS 0.07 (the “Ordinary Shares”), in a private investment in public equity (the “PIPE Offering”). The purchase price is set at $17.20 per share. The gross proceeds from the PIPE Offering are $25 million. MediWound plans to use the net proceeds to advance EscharEx pre-commercial activities, expedite the development of large-scale manufacturing capabilities specifically for EscharEx, and support general corporate purposes. The PIPE Offering is expected to close within several days, subject to satisfaction of customary closing conditions.

“We are proud to have the strong support of Mölnlycke, and of our new and existing investors in this financing,” said Ofer Gonen, Chief Executive Officer of MediWound. “This significant investment will enable us to further strengthen our strategic plans for EscharEx, creating substantial long-term value for our stakeholders and help improve the standard of care for patients.”

“We are very excited to make this strategic investment in MediWound. It aligns with our strategy to bring radical innovations into the wound care space and provide alternative solutions to the more traditional debridement options to improve clinical outcomes and patient experience,” said Zlatko Rihter, CEO of Mölnlycke. “This investment, coupled with the initiation of the EscharEx Phase III clinical trial, positions both companies for a successful future partnership.”

Concurrently with the PIPE Offering, MediWound and Mölnlycke entered into a collaboration agreement to strengthen their partnership (the "Collaboration Agreement"). Under the key terms of this agreement, Mölnlycke is granted specific rights, including a representative to attend meetings of the Company's R&D Committee. Additionally, Mölnlycke will be able to participate in potential strategic partnership discussions and M&A processes under certain circumstances. The Collaboration Agreement also contains a stand-still clause that limits Mölnlycke's ownership to no more than 9.99% of the Company's issued and outstanding Ordinary Shares.

The Company also entered into a registration rights agreement with several investors named in the Share Purchase Agreement (the “Registration Rights Agreement”), providing them with customary registration rights in connection with the Ordinary Shares.

The Ordinary Shares being sold to investors in the PIPE Offering are being offered and sold in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any other applicable state securities laws. Accordingly, those securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to the Registration Rights Agreement, the Company has agreed to file a registration statement with the SEC registering the resale of the Ordinary Shares issued in the PIPE Offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these Company securities, nor shall there be any sale of these Company securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

https://ir.mediwound.com/node/11146/html

MediWound jumps on reports of $400m bid by Solventum

Ofer Gonen credit: Eran Lavi

7 Jul, 2024 16:20

Shiri Habib-Valdhorn

The Israeli company has developed a pineapple-plant based product for treatment of burns and wounds.
Israeli biopharmaceutical company MediWound (Nasdaq: MDWD) saw its share price jump 35% on Friday on Wall Street to $19.60, giving it a market cap of $182 million. At one point in trading on Friday, the share price was up 60%, after media reports that US company Solventum (NYSE: SOLV) had offered to acquire MediWound for $400 million, or $34 per share.

Last year MediWound, which has developed a pineapple-plant based product for treatment of burns and wounds, almost doubled its market cap. Even so its share price is well below its peak in 2021.

MediWound, which is managed by CEO Ofer Gonen, has made no official comments on the reports of Solventum's offer but market sources believe that any negotiations are still in their early stages and no deal is yet on the table.

Published by Globes, Israel business news - en.globes.co.il - on July 7, 2024.

Buying some Mediwound today.

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$MDWD

The trial showed absolute superiority of Medivand's product over Santyl in terms of the percentage of cases that reached complete wound healing during the first two weeks of treatment (63% vs. 0%); The median time for complete healing of the wound (nine days compared to not reaching complete healing in the two weeks of treatment); and complete closure of the wound (50% compared to 0% for Santyl).

These results in themselves placed Medivend in a good position to become the leading product in the market - and the company's situation was further improved two months later. The CMS, the American federal agency that manages the insurance coverage policy of the American state health insurance companies Medicaid and Medicare, has published a hearing on the background of its intention to make a fundamental change in the insurance coverage policy for skin graft products - which are intended for the treatment of diabetic wounds and wounds that are difficult to heal. This is to ensure that the federal insurance companies will not waste their money on products that did not show evidence of therapeutic effectiveness within four treatments and for a maximum of 12 weeks.

If the intention becomes policy, 85 out of 100 preparations will be removed from the market, mainly those based on tissue transplantation for the treatment of diabetic wounds and wounds caused by venous insufficiency.

In this situation, Askerx - which is expected to receive insurance coverage based on the price of the market-leading product Santyl, and assuming that it will successfully pass the clinical trial, in which 216 patients will participate in the third and decisive phase - will become an even more attractive asset for wound care companies, and with it Medivand. This, assuming that these companies will lose the solution they had for this market, following the policy change.

Among those companies is the Danish Coloplast, which has lost $2.9 billion of its value since the end of April - among other things, because less than a year ago it purchased the Icelandic company Kerecis for $1.2 billion, whose product lost the insurance coverage it had until now.

Ofer Gonen, CEO of Medivand, said in response: "The company's policy is not to respond to rumors. We are focused on building a long-term future for Medivend and ensuring the supply of essential medicines to millions of patients around the world. We have Nexobride, a drug for severe burns that saves lives, and we see its importance, especially in the difficult days since October 7. In addition, we have Ascarax, a chronic wound healing drug that is in advanced development. It is the only drug in the world that threatens Santyl's dominance

Medivend, which developed a product for healing wounds, became an attractive target for acquisition
A successful trial of the flagship product that showed superiority over the leading product for healing chronic wounds, fundamental changes in insurance policy in the US and the product's success in treating the burns of the war-wounded in Gaza - all of these made Medivand an attractive asset for wound healing companies ¦ The American Solventum is interested in purchasing Medivand at a premium of 118% at its current price

Ofer Gonen, CEO of Medivand: "The company's policy is not to respond to rumors" Photo: Eran
July 4, 2024
The Medivend company recently received an application for its purchase from the Solventum company (Solventum) according to a company value of 400 million dollars. This value reflects a price of $34 per fully diluted Mediwind share.
The appeal sparked internal disputes in the company: on the one hand, board members who prefer to wait for the results of the third and decisive clinical trial of the company's main product, and believe that the proposal does not reflect the company's economic value; On the other hand, factors in the company's management who believe that it would be a mistake to ignore the risk of failure in the trial or a delay in receiving marketing approval from the American Food and Drug Administration (FDA), and the fact that the deal reflects a premium of 118% compared to the current price of the stock and a premium of 370% compared to the low price of the stock in September 2023.

Solventum is a pharmaceutical and medical preparations company that was split in early April 2024 from the 3M industrial concern, which continues to own 19.9% ??of its shares. It trades at a value of 9 billion dollars, having lost 35% since it started trading.

Clal's Mediwind takes advantage of the momentum: raised $27 million in Nasdaq | Yoram Gavizon
Medivend received FDA approval for an innovative treatment for moderate to severe burns Yoram Gavizon
Medivand's stock, which develops preparations for the treatment of burns and chronic wounds using an enzyme extracted from the stem of the pineapple, has faltered for years following the disappointment of sales of NexoBrid, the product it developed for the debridement (removal of the dead tissue) of moderate to severe burns, and the marketing agreement for the product in the US, that the company signed with Vericel in 2019.

In the last few months Medivand recovered and completed a 116% increase to a value of 147 million dollars. The improvement is due to several main events. The first is the war against Hamas, which proved the effectiveness of Nexobride in treating severe burns of civilians who were hit by the Hamas attack on October 7. The effectiveness of Nexobride was also proven in the treatment of fighters who suffered severe burns in the battles in Gaza, and in some cases there was fear for their lives.

Prof. Yosef Chaik, Director of the Department of Plastic Surgery and Head of the National Center for Intensive Care of Burns, explained that the accepted assessment is that a person's chances of dying from burns in a multi-casualty incident and in war is a combination of his age and the extent of the burn. That is, a 30-year-old patient with burns on 40% of his body surface has a 70% chance of dying from his wounds.

According to him, the Nexobride treatment - a non-surgical alternative to removing the dead tissue with a special knife - saves blood doses and an operating room, which is a resource in short supply especially in war; and shortens the hospitalization and recovery time.

Hayek noted that the Ministry of Health purchased large quantities of the preparation from Medivend already on October 8 for the benefit of the hospitals, according to his recommendation as the chairman of the Israeli Association for Plastic and Aesthetic Surgery, and with the help of Medivend, which diverted most of its production in favor of the Israeli health system.

Approved for marketing in more than 44 countries

One of the company's employees experienced firsthand - almost literally - the effectiveness of Nexobride. His son is an armor fighter, who was injured in early April fighting in Gaza along with three of his friends, as a result of a shell igniting in a tank. He suffered 40% burns. The son was treated with Nexobride, which has become the hospital's standard of care, and shows a good recovery which is reflected in the fact that he did not need a skin graft, and his scarring is relatively good - that is, there are no bubbles and no lifting of the scar area. Israel is not the only country that discovered Nexobrid - the product has been approved for marketing in 44 countries.

As part of the phenomenon of the renewed preparation of countries following the Ukraine war, Medivend reported in a presentation to investors that global demand exceeds three times its production capacity. Medivand is currently investing in increasing the production capacity at its factory in Yavne sixfold. The company estimated that sales of the product would grow at an annual rate of 40%, from $19 million in 2023 (65% of this amount to the US Department of Defense) to $39 million in 2026.

However, Nexobride is probably not the product for which Medivand receives inquiries from multinational companies in the field of wound medicine such as Solventum, Coloplast, Convatec, Integra and Molnlycke.

Not just burns

Medivend is developing another product based on the same enzyme, albeit at a different concentration. This is Escharex, which is intended for the lubrication of chronic and difficult-to-heal wounds - for example, wounds on the feet of diabetic patients and wounds due to venous insufficiency. This product addresses a much larger market—$2 billion in the US—and should challenge the dominance of Smith & Nephew's Santyl product, whose sales are $360 million per year.

Medivand published the results of the phase II clinical trial in February, which included a head-to-head comparison of the effectiveness of Ascarax with Santyl, which is an enzyme-based gel.

The experiment showed absolute superiority of Medivend's product

Medivend, which developed a product for healing wounds, became an attractive target for acquisition

A successful trial of the flagship product that showed superiority over the leading product for healing chronic wounds, fundamental changes in insurance policy in the US and the product's success in treating the burns of the war-wounded in Gaza - all of these made Medivand an attractive asset for wound healing companies ¦ The American Solventum is interested in purchasing Medivand at a premium of 118% at its current price

Ofer Gonen, CEO of Medivand: "The company's policy is not to respond to rumors"

July 4, 2024

The Medivend company recently received an application for its purchase from the Solventum company (Solventum) according to a company value of 400 million dollars. This value reflects a price of $34 per fully diluted Mediwind share.
The appeal sparked internal disputes in the company: on the one hand, board members who prefer to wait for the results of the third and decisive clinical trial of the company's main product, and believe that the proposal does not reflect the company's economic value; On the other hand, factors in the company's management who believe that it would be a mistake to ignore the risk of failure in the trial or a delay in receiving marketing approval from the American Food and Drug Administration (FDA), and the fact that the deal reflects a premium of 118% compared to the current price of the stock and a premium of 370% compared to the low price of the stock in September 2023.

Solventum is a pharmaceutical and medical preparations company that was split in early April 2024 from the 3M industrial concern, which continues to own 19.9% ??of its shares. It trades at a value of 9 billion dollars, having lost 35% since it started trading.

Clal's Mediwind takes advantage of the momentum: raised $27 million in Nasdaq | Yoram Gavizon
Medivend received FDA approval for an innovative treatment for moderate to severe burns Yoram Gavizon
Medivand's stock, which develops preparations for the treatment of burns and chronic wounds using an enzyme extracted from the stem of the pineapple, has faltered for years following the disappointment of sales of NexoBrid, the product it developed for the debridement (removal of the dead tissue) of moderate to severe burns, and the marketing agreement for the product in the US, that the company signed with Vericel in 2019.

In the last few months Medivand recovered and completed a 116% increase to a value of 147 million dollars. The improvement is due to several main events. The first is the war against Hamas, which proved the effectiveness of Nexobride in treating severe burns of civilians who were hit by the Hamas attack on October 7. The effectiveness of Nexobride was also proven in the treatment of fighters who suffered severe burns in the battles in Gaza, and in some cases there was fear for their lives.

Prof. Yosef Chaik, Director of the Department of Plastic Surgery and Head of the National Center for Intensive Care of Burns, explained that the accepted assessment is that a person's chances of dying from burns in a multi-casualty incident and in war is a combination of his age and the extent of the burn. That is, a 30-year-old patient with burns on 40% of his body surface has a 70% chance of dying from his wounds.

According to him, the Nexobride treatment - a non-surgical alternative to removing the dead tissue with a special knife - saves blood doses and an operating room, which is a resource in short supply especially in war; and shortens the hospitalization and recovery time.

Hayek noted that the Ministry of Health purchased large quantities of the preparation from Medivend already on October 8 for the benefit of the hospitals, according to his recommendation as the chairman of the Israeli Association for Plastic and Aesthetic Surgery, and with the help of Medivend, which diverted most of its production in favor of the Israeli health system.

Approved for marketing in more than 44 countries

One of the company's employees experienced firsthand - almost literally - the effectiveness of Nexobride. His son is an armor fighter, who was injured in early April fighting in Gaza along with three of his friends, as a result of a shell igniting in a tank. He suffered 40% burns. The son was treated with Nexobride, which has become the hospital's standard of care, and shows a good recovery which is reflected in the fact that he did not need a skin graft, and his scarring is relatively good - that is, there are no bubbles and no lifting of the scar area. Israel is not the only country that discovered Nexobrid - the product has been approved for marketing in 44 countries.

As part of the phenomenon of the renewed preparation of countries following the Ukraine war, Medivend reported in a presentation to investors that global demand exceeds three times its production capacity. Medivand is currently investing in increasing the production capacity at its factory in Yavne sixfold. The company estimated that sales of the product would grow at an annual rate of 40%, from $19 million in 2023 (65% of this amount to the US Department of Defense) to $39 million in 2026.

However, Nexobride is probably not the product for which Medivand receives inquiries from multinational companies in the field of wound medicine such as Solventum, Coloplast, Convatec, Integra and Molnlycke.

Not just burns

Medivend is developing another product based on the same enzyme, albeit at a different concentration. This is Escharex, which is intended for the lubrication of chronic and difficult-to-heal wounds - for example, wounds on the feet of diabetic patients and wounds due to venous insufficiency. This product addresses a much larger market—$2 billion in the US—and should challenge the dominance of Smith & Nephew's Santyl product, whose sales are $360 million per year.

Medivand published the results of the phase II clinical trial in February, which included a head-to-head comparison of the effectiveness of Ascarax with Santyl, which is an enzyme-based gel.

The experiment showed absolute superiority of Medivend's product

MDWD...on watch tomorrow...

MediWound jumps amid report of $34 a
share takeover offer from Solventum

Tough month for MDWD. Company seems positive RE: Q1.

What does this mean?
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.

MediWound Reports First Quarter 2024 Financial Results and Provides Company Update

https://finance.yahoo.com/news/mediwound-reports-first-quarter-2024-110000127.html

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 Call
MediWound 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.

MDWD new 52 week high

MediWound to Present New Data from EscharEx® Phase II Studies at Three Leading Wound Care Conferences

https://finance.yahoo.com/news/mediwound-present-data-escharex-phase-120000249.html

Oral presentations include additional comparative data between EscharEx® and SANTYL®, and new analyses show strong correlation between wound bed preparation and wound healing

Analyses validate the planned design and endpoints of the upcoming Phase III study

YAVNE, Israel, April 25, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today that recent clinical data from EscharEx® Phase II studies will be presented throughout May 2024 at the largest, most prestigious annual meetings in the field of chronic wound care: the European Wound Management Association (EWMA), the Wound Healing Society (WHS), and the Symposium on Advanced Wound Care (SAWC).

The oral presentations on EscharEx will include:

Comparative data of EscharEx vs. SANTYL® that demonstrate EscharEx’s superiority over the current leading enzymatic debridement agent

New analyses from the ChronEx phase II study, showing high correlation between wound bed preparation and wound healing

These data indicate that EscharEx could substantially improve wound care for patients with debilitating chronic wounds, providing significant benefits over the current standard of care. Additionally, the findings support the design and endpoints of the upcoming Phase III study, which is expected to begin in the second half of 2024.

"We are delighted to present the results of additional analyses from EscharEx Phase II studies in chronic hard-to-heal wounds, including the positive comparative data with SANTYL®, the current dominant standard of care for enzymatic debridement," said Dr. Robert J. Snyder, Chief Medical Officer of MediWound. "With its robust efficacy, favorable safety profile, and multimodal mechanistic effects demonstrated in these Phase II studies, we believe that EscharEx can significantly advance wound care and has the potential to become a major player in the global wound care market."

2024 European Wound Management Association (EWMA), London, United Kingdom

Time:

May 1, at 11:45am

Title:

Comparison of bromelain-based enzymatic debridement to collagenase ointment

Presenter:

Cyaandi R. Dove, DPM





Time:

May 3, at 8:30am

Title:

VLU wound bed preparation is highly correlated with wound closure

Presenter:

Robert J. Snyder, DPM, MSc, MBA





2024 Wound Healing Society Conference (WHS), Orlando, Florida

Time:

May 16, at 10:30am

Title:

Comparison of bromelain-based enzymatic debridement to collagenase SANTYL® ointment

Presenter:

Cyaandi R. Dove, DPM





Time:

May 16, at 10:30am

Title:

VLU wound bed preparation is highly correlated with wound closure

Presenter:

Marissa Carter, MA, PhD





2024 Symposium on Advanced Wound Care (SAWC), Orlando, Florida

Time:

May 17, at 7:30am

Location:

SAWC Innovation Theater

Title:

EscharEx, an innovative multimodal enzymatic debridement agent for the treatment of chronic wounds

Presenters:

Vickie R. Driver, DPM, MS, FACFAS, John C. Lantis, MD, Cyaandi R. Dove, DPM, and Robert J. Snyder, DPM, will discuss the importance of wound bed preparation in wound healing, EscharEx’s mechanism of action, results from the ChronEx Phase II study including case studies showcasing the treatment experience, and the design of the upcoming Phase III study in venous leg ulcers (VLU)

18.28 +2.28 (+14.25%)
At close: April 16 at 4:00 PM EDT
18.83 +0.55 (+3.01%)
After hours: 7:53 PM EDT
Volume 223,344
Avg. Volume 70,275
WoW!

MDWD over $10
Next day settlement begins 5/27 per SEC mandate

MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update.

https://finance.yahoo.com/news/mediwound-reports-fourth-quarter-full-110000175.html

$19 million revenue in 2023; $24 million projected revenue in 2024

NexoBrid® commercially launched in U.S., Japan, India

Potential blockbuster EscharEx® to begin Phase III in the second half of 2024

$42 million cash runway through profitability

Conference call today, March 21 at 8:30am Eastern Time

YAVNE, Israel, March 21, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

“2023 was an exceptional year for NexoBrid driven by new market launches, expanded indications, substantial new governmental grants, and increased global demand. Additionally, this lifesaving treatment was successfully battle-tested in real-life burn mass casualty incidents (BMCI) during the war in Israel. Furthermore, the full capacity of our new manufacturing facility in 2025 will enable us to meet the soaring demand of NexoBrid,” said Ofer Gonen, CEO of MediWound. “Recent clinical data further validates our pipeline product, EscharEx, demonstrating that it significantly outperformed SANTYL® in a head-to-head comparative analysis. The product has attracted research collaborations with industry leaders 3M, Mölnlycke and MIMEDX and the Phase III study is set to begin in the second half of 2024. We strongly believe in the exciting future ahead for MediWound.”

2023 Highlights and Recent Developments:

NexoBrid®

Expanded commercial availability to U.S., Japan, and India, leading to $19 million revenue in 2023, and a surge of orders for 2024, with $24 million projected revenue.

Construction of a new GMP-compliant state-of-the-art manufacturing facility is on track for mid-2024 completion. It is projected to achieve a 6-fold manufacturing capacity increase in 2025.

Commercial Activities:

Launched in the U.S. by Vericel Corp, with more than 50 burn centers submitting packages to Pharmacy and Therapeutics (P&T) committees and more than 25 already approved. Furthermore, the Centers for Medicare & Medicaid Services (CMS) awarded NexoBrid a permanent J code and granted it transitional pass-through payment status, enhancing its accessibility and reimbursement potential.

Launched in Japan through Kaken Pharmaceuticals, and in India through Bharat Serums and Vaccines (BSV).

Expanded European market presence by establishing a collaboration with PolyMedics Innovations (PMI) for the promotion of NexoBrid in Germany, Austria, Belgium, the Netherlands, and Luxembourg.

Successfully fulfilled emergency demand in Israel to treat mass burn casualties resulting from the war, consuming all available non-U.S. inventory.

Government Funding:

Awarded $13.0 million R&D funding by U.S. Department of Defense (DoD) to develop and produce a new NexoBrid temperature stable formulation for use as a non-surgical solution for field-care burn treatment for the U.S. Army.

Awarded $10.1 million in additional funding from the Biomedical Advanced Research and Development Authority (BARDA) for emergency preparedness product replenishment and R&D activities.

Pediatric label expansion:

Gained European Commission approval for the removal of eschar in deep partial- and full-thickness thermal burns for all ages.

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.

EscharEx®

Aligned the Phase III study protocol with the European Medicine Agency (EMA) and the FDA, and expected to submit a final protocol in the first half of 2024. 216 patients will be treated globally across 40 sites with either EscharEx or a gel vehicle placebo, with an interim assessment to be performed once 67% of participants complete the study. Study initiation is expected in the second half of 2024.

Established research collaborations with 3M, Mölnlycke and MIMEDX to support the EscharEx Phase III clinical study.

Conducted head-to-head comparative analysis of EscharEx vs SANTYL®. Data from a Phase II randomized controlled study demonstrated significant superiority of EscharEx over SANTYL in multiple clinical outcome measures: incidence of complete debridement; median time to achieve complete debridement; incidence of achieving wound bed preparation (WBP); median time to achieve WBP; and time to wound closure. The data is scheduled for oral presentation in May 2024 at three leading annual congresses dedicated to advanced wound care: The Wound Healing Society (WHS), the Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA).

MW005

Reported positive results of the Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data showed MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions.

Fourth Quarter 2023 Financial Highlights

Revenue: Revenue for the fourth quarter 2023 was $5.3 million, compared to $11.6 million in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.

Gross Profit: Gross profit in the fourth quarter 2023 was $0.7 million, representing 13.5% of the total revenue in the fourth quarter of 2023, compared to $8.2 million, representing 70.2% of total revenue in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel in the fourth quarter of 2022.

Expenditures:

Research and development expenses in the fourth quarter 2023 were $1.8 million compared to $2.7 million in the fourth quarter of 2022. This change is primarily attributed to the completion of EscharEx phase II study in 2022.

Selling, general, and administrative expenses in the fourth quarter 2023 were $2.8 million, compared to $3.0 million in the fourth quarter of 2022.

Operating Results: Operating loss in the fourth quarter of 2023 was $3.9 million, compared to an operating profit of $2.1 million in the fourth quarter of 2022.

Net Loss: Net loss in the fourth quarter of 2023 was $1.7 million or $0.19 per share, compared to the net loss of $7.5 million, or $1.18 per share in the fourth quarter of 2022. The decrease is primarily attributed to a favorable adjustment from the revaluation of warrants.

Non-GAAP Adjusted EBITDA: Adjusted EBITDA in the fourth quarter of 2023 was a loss of $3.2 million, compared to a profit of $3.4 million in the fourth quarter of 2022.

Full Year 2023 Financial Highlights

Revenue: Revenue for the year ended December 31, 2023, was $18.7 million, compared to $26.5 million for the year ended December 31, 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.

Gross Profit: Gross profit for the year ended December 31, 2023, was $3.6 million with a gross margin of 19.1%, compared to $13.2 million with a gross margin of 49.7% in the prior year period. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.

Expenditures:

Research and development expenses for the year ended December 31, 2023, were $7.5 million compared to $10.2 million in the prior year.

Selling, general, and administrative expenses for the year ended December 31, 2023, were $11.6 million, compared to $10.6 million in the prior year.

Operating Results: Operating loss for the year ended December 31, 2023, was $15.3 million, compared to an $8.3 million loss in the year ended December 31, 2022.

Net Loss: Net loss in the year ended December 31, 2023 was $6.7 million or $0.75 per share, compared to the net loss of $19.6 million, or $3.93 per share for the year ended December 31, 2022.

Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the year ended December 31, 2023 was a loss of $12.3 million, compared to a loss of $4.4 million for the year ended December 31, 2022.

Balance Sheet Highlights

As of December 31, 2023, the Company’s cash, restricted cash, and investments were $42.1 million, compared to $34.1 million reported on December 31, 2022. In the first quarter of 2023, the Company raised a gross amount of $27.5 million through a registered direct offering. The company used $17.1 million to fund its activities. The existing cash and restricted cash, and investments will provide sufficient funds through profitability.

Conference Call

MediWound management will host a conference call for investors on Thursday, March 21, 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 solutions that seek to improve existing standards of care. MediWound is committed to providing rapid and effective biologics that improve patient experiences and outcomes, 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 product and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a Phase I/II study.

For more information visit www.mediwound.com and follow the Company on LinkedIn and X.

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 Ferry

Chief Financial Officer

Managing Director, LifeSci Advisors

MediWound Ltd.

617-430-7576

ir@mediwound.com

daniel@lifesciadvisors.com





Media Contact:



Ellie Hanson



FINN Partners for MediWound



ellie.hanson@finnpartners.com



929-588-2008





MediWound, Ltd.



Audited Condensed Consolidated Statements of Financial Position

U.S. dollars in thousands





Dec 31,



2023



2022

CURRENT ASSTS:







Cash and cash equivalents and short-term deposits

41,708



33,895

Trade and other receivable

5,141



9,982

Inventories

2,846



1,963

Total current assets

49,695



45,840









Non-current assets







Other receivables

673



364

Property, plant and equipment, net

9,228



2,366

Right of use assets, net

6,698



1,215

Intangible assets, net

165



231

Total non-current assets

16,764



4,176









Total assets

66,459



50,016









CURRENT LIABILITIES:







Current maturities of long-term liabilities

1,410



2,242

Trade payables and accrued expenses

5,528



5,656

Other payables

3,891



4,159

Total current liabilities

10,829



12,057

Warrants, net

7,296



15,606

Liabilities in respect of IIA grants

7,677



7,445

Liability in respect of TEVA

2,256



2,788

Lease liabilities

6,350



846

Severance pay liability, net

456



360

Total non-current liabilities

24,035



27,045









Shareholders' equity

31,595



10,914

Total liabilities & equity

66,459



50,016













MediWound, Ltd.



Audited 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)





Twelve months ended



Three months ended



Dec 31,



Dec 31,



2023



2022



2023



2022

Total Revenues

18,686



26,496



5,338



11,618

Cost of revenues

15,108



13,331



4,619



3,460

Gross profit

3,578



13,165



719



8,158

















Research and development

7,467



10,181



1,808



2,699

Selling and Marketing

4,844



3,725



1,209



692

General and administrative

6,768



6,920



1,583



2,269

Other (Income) expenses

(211)



684



13



375

Operating loss

(15,290)



(8,345)



(3,894)



2,123

















Financial income (expenses), net

8,759



(11,176)



2,271



(9,515)

Taxes on income

(185)



(78)



(120)



(65)

Net loss

(6,716)



(19,599)



(1,743)



(7,457)

Foreign currency translation adjustments

(13)



14



(11)



(20)

Total comprehensive loss

(6,729)



(19,585)



(1,754)



(7,477)

















Basic and diluted loss per share:











Net loss per share

(0.75)



(3.93)



(0.19)



(1.18)

















Weighted average number of ordinary shares

9,013,144



4,987,069



9,219,923



6,332,981





















MediWound, Ltd.



Audited Condensed Consolidated Statements of Cash Flows

U.S. dollars in thousands





Twelve months ended



Three months ended



Dec 31,



Dec 31,



2023



2022



2023



2022



Audited



Unaudited

Cash Flows from Operating Activities:















Net Loss

(6,716)



(19,599)



(1,743)



(7,457)

Adjustments to reconcile net loss to net cash used in operating activities:































Adjustments to profit and loss items:















Depreciation and amortization

1,303



1,272



346



284

Share-based compensation

1,940



1,946



298



642

Revaluation of warrants accounted at fair value

(8,310)



8,977



(1,603)



8,977

Issuance expenses of warrants through profit and loss

-



1,911



-



1,523

Revaluation of liabilities in respect of IIA grants

427



(132)



(282)



(944)

Revaluation of liabilities in respect of TEVA

468



533



111



129

Financing income and exchange differences of lease liability

257



(109)



463



37

Increase in severance liability, net

83



109



3



45

Other income

(211)



-



13



-

Financial income, net

(2,231)



(74)



(836)



(408)

Un-realized foreign currency loss (gain)

189



525



(347)



60



(6,085)



14,958



(1,834)



10,345

Changes in asset and liability items:















Decrease (increase) in trade receivables

5,658



(7,582)



(528)



(5,137)

Decrease (increase) in inventories

(906)



(721)



782



(113)

Decrease (increase) in other receivables

(894)



364



(696)



221

Increase (decrease) in trade payables and accrued expenses

(594)



414



1,093



784

Increase (decrease) in other payables

(928)



281



311



2,107



2,336



(7,244)



962



(2,138)

Net cash used in operating activities

(10,465)



(11,885)



(2,615)



750





















MediWound, Ltd.



Audited Condensed Consolidated Statements of Cash Flows

U.S. dollars in thousands



Cash Flows from Investing Activities:















Purchase of property and equipment

(6,464)



(555)



(2,209)



(174)

Interest received

1,947



74



722



71

Proceeds from (Investment in) short term bank deposits, net

(29,804)



-



6,515



2,499

Net cash used in investing activities

(34,321)



(481)



5,028



2,396

















Cash Flows from Financing Activities:















Repayment of lease liabilities

(778)



(701)



(204)



(170)

Proceeds from issuance of shares and warrants, net

24,909



38,390



-



16,475

Repayments of IIA grants, net

(380)



(258)



-



-

Repayment of liabilities in respect of TEVA

(834)



(1,667)



-



(417)

Net cash provided by (used in) financing activities

22,917



35,764



(204)



15,588

















Exchange rate differences on cash and cash equivalent balances

(160)



(549)



378



(44)

Increase (decrease) in cash and cash equivalents

(22,029)



22,849



2,587



18,990

Balance of cash and cash equivalents at the beginning of the period

33,895



11,046



9,279



14,905

Balance of cash and cash equivalents at the end of the period

11,866



33,895



11,866



33,895





















MediWound, Ltd.



Adjusted EBITDA

U.S. dollars in thousands





Twelve months ended



Three months ended

Dec 31,



Dec 31,



2023



2022



2023



2022

Net loss

(6,716)



(19,599)



(1,743)



(7,457)

Adjustments:















Financial income (expenses), net

8,759



(11,176)



2,271



(9,515)

Other (Income) expenses, net

211



(684)



(13)



(375)

Taxes on income

(185)



(78)



(120)



(65)

Depreciation and amortization

(1,303)



(1,272)



(346)



(284)

Share-based compensation expenses

(1,940)



(1,946)



(298)



(642)

Total adjustments

5,542



(15,156)



1,494



(10,881)

Adjusted EBITDA

(12,258)



(4,443)



(3,237)



3,424

MediWound to Report Fourth Quarter and Full Year 2023 Financial Results

https://finance.yahoo.com/news/mediwound-report-fourth-quarter-full-120000694.html

Conference Call and Webcast Scheduled for Thursday, March 21st at 8:30 am Eastern Time

YAVNE, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the fourth quarter and full year ended December 31, 2023 on Thursday, March 21, 2024.

Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions.

Dial-in and call details are as follows:

Conference Call & Webcast Details

Toll-Free:

1-833-630-1956

Israel:

1-80-921-2373

International:

1-412-317-1837

Webcast:

To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay on the Investors section of the MediWound website.

MDWD 10Q due March 14

MDWD new 52 week hi

Retail investors who hold 38% of MediWound Ltd. (NASDAQ:MDWD) gained 15%, institutions profited as well
editorial-team@simplywallst.com (Simply Wall St)

https://finance.yahoo.com/news/retail-investors-hold-38-mediwound-113038913.html
Thu, March 7, 2024 at 1:30 PM GMT+2

Key Insights
MediWound's significant retail investors ownership suggests that the key decisions are influenced by shareholders from the larger public

A total of 10 investors have a majority stake in the company with 51% ownership

16% of MediWound is held by Institutions

To get a sense of who is truly in control of MediWound Ltd. (NASDAQ:MDWD), it is important to understand the ownership structure of the business. The group holding the most number of shares in the company, around 38% to be precise, is retail investors. In other words, the group stands to gain the most (or lose the most) from their investment into the company.

While retail investors were the group that reaped the most benefits after last week’s 15% price gain, institutions also received a 16% cut.

16.58+1.16 (+7.52%)
At close: March 6 04:00PM EST
16.80 +0.22 (+1.33%)
After hours: 08:00PM EST
Volume 259,831
Avg. Volume 38,857

MediWound (MDWD) Moves 7.1% Higher: Will This Strength Last?

https://finance.yahoo.com/news/mediwound-mdwd-moves-7-1-134600263.html

The sheer volume with daily 52w/h indicates
positive developments in the works.
At $16 a new w/h high is set.

Loving the energy this has. The high $20 price targets seem really high for a stock already at 52 week highs, but no complaints here.

15.42+1.02 (+7.08%)
At close: March 5 04:00PM EST
Volume 133,218
Avg. Volume 37,013
Robust Volume, a Bullish sign!

15.48+1.08 (+7.50%)
As of 09:55AM EST. Market open.
Volume 47,122
Avg. Volume 36,598
Just broke 52W/H

14.40+0.20 (+1.41%)
At close: March 4 04:00PM EST
Volume 189,777
Avg. Volume 34,001
Nice Finish.

The one problem MDWD has is limited production capacity:
The objective of this agreement is to establish, commission, and validate a cutting-edge, sterile, and GMP-compliant manufacturing facility. The venture aims to increase production capacity significantly, projected to expand to six times the current capacity, aligning with strategic plan to meet the escalating global demand for NexoBrid.

The new facility, equipped with fully operational clean rooms, will be exclusively designed for NexoBrid production. It will comply with stringent regulations from the GMP, FDA, EMA, Israeli Ministry of Health, and relevant Israeli regulatory bodies. An estimated $12 million will be invested in the project, set for completion by mid-2024, with full-scale manufacturing expected to commence in 2025.
From:
https://uk.marketscreener.com/quote/stock/MEDIWOUND-LTD-16056541/news/Mediwound-Ltd-Signs-A-Turnkey-Scale-Up-Agreement-with-Biopharmax-Group-Ltd-44356728/

Mazel Tov!
Mazel Tov & Good Fortune!

Well then all I have to say is Mazel Tov!

I didn't mean to sound obnoxious.
No offense taken.
Remind me again why are we holding?
1/FDA approval to:MediWound Announces that FDA has Accepted for Review the
Supplement to the NexoBrid BLA to Include Pediatric Patients with Severe Thermal Burns.
IMO the approval is just around the corner, any day now.
FYI: “From a commercial perspective, pediatric burn victims comprise more than 30% of the total burn population making this new indication a significant addition to our addressable market.”
2/Improvement in revenue as a result of the war in Gaza as well as in Ukraine.

Ok . . . so this stock has so little volume and visibility that they haven't updated the targets in over a year? Remind me again why are we holding?

Edit: I didn't mean to sound obnoxious. This thing has been good to me. I haven't held that long.