Mediwound Ltd (MDWD)

[midastouch017]

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

[PennyRookie0]

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.

[midastouch017]

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.

[Monksdream]

MDWD new 52 week high

[midastouch017]

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)

[midastouch017]

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!

[Monksdream]

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

[midastouch017]

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

[e-mail]

[e-mail]





Media Contact:



Ellie Hanson



FINN Partners for MediWound



[e-mail]



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

[midastouch017]

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.

[Monksdream]

MDWD 10Q due March 14

[Monksdream]

MDWD new 52 week hi

[midastouch017]

Retail investors who hold 38% of MediWound Ltd. (NASDAQ:MDWD) gained 15%, institutions profited as well
[e-mail] (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.

[midastouch017]

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

[midastouch017]

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

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

[midastouch017]

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

[PennyRookie0]

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.

[midastouch017]

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!

[midastouch017]

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

[midastouch017]

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

[midastouch017]

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/

[midastouch017]

Mazel Tov!

Mazel Tov & Good Fortune!

[PennyRookie0]

Well then all I have to say is Mazel Tov!

[midastouch017]

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.

[PennyRookie0]

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.

[midastouch017]

what's behind the stock analysts $28+ price targets?

Methinks they mean the pre split price:

MediWound Ltd. (MDWD) will effect a one-for-seven (1-7) reverse split of its Ordinary Shares. The reverse stock split will become effective on Tuesday, December 20, 2022

Namely meaning a price target of $4+

[PennyRookie0]

This has been a good one. I'm up about 15%. Since it's already at 52 WH, what's behind the stock analysts $28+ price targets?

[midastouch017]

14.53+0.53 (+3.79%)
As of 11:31AM EST. Market open.
Just broke 52 w/h

[midastouch017]

14.40+1.00 (+7.44%)
Just Broke 52W/H on
robust volume!

[midastouch017]

14.37+0.97 (+7.24%)
As of 12:49PM EST. Market open.
Volume 71,447
Avg. Volume 32,127
Good News Soon?

[midastouch017]

MediWound stock climbs 9% on Phase 2 data for wound care treatment

Feb. 12, 2024 12:19 PM ETMediWound Ltd. (MDWD) Stock

By: Val Brickates Kennedy, SA News Editor

Shares of MediWound (NASDAQ:MDWD) climbed 9% Monday after
the Israeli company reported positive Phase 2 data for its chronic wound treatment EscharEx.

The study was a head-to-head comparison of ExcharEx with collagenase Santyl ointment in the debridement of non-viable tissue and promotion of healthy, highly vascularized tissue in patients with chronic skin ulcers.

MediWound said Santyl is currently the market leader in enzymatic debridement products for wound care, with annual US sales in excess of $360M.

A Phase 3 study of EscharEx is expected to begin in the second half of 2024.

[midastouch017]

12.93+1.03 (+8.64%)
As of 11:41AM EST. Market open.
Volume 52,664
Avg. Volume 29,749
Robust Volume too.

[midastouch017]

13.00 +1.10 (+9.24%)
Pre-Market: 08:25AM EST
Very Nice Market Reaction To The News!

[midastouch017]

MediWound to Participate in Two Upcoming Investor Conferences

https://finance.yahoo.com/news/mediwound-participate-two-upcoming-investor-130000573.html

YAVNE, Israel, Feb. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced its participation in the upcoming Oppenheimer 34th Annual Life Sciences Conference, taking place virtually on February 13-14, 2024, as well as the upcoming TD Cowen 44th Annual Health Care Conference, taking place in Boston on March 4-6, 2024.

Oppenheimer 34th Annual Life Sciences Conference

Date: Tuesday, February 13, 2024

Time: 8:40am ET

Format: Fireside Chat

Host: Francois Brisebois, Managing Director & Senior Analyst

TD Cowen 44th Annual Health Care Conference

Date: Monday, March 4, 2024

Time: 11:10am ET

Location: Boston, MA

The MediWound management team will host one-on-one meetings during both conferences. Interested investors should contact their Oppenheimer and/or TD Cowen representative to schedule meetings. Links to access the fireside chat and company presentation will also be posted to MediWound’s website on the Events & Presentations page of the Investors section.

[midastouch017]

MediWound Announces Positive Results in Head-to-Head Comparison of EscharEx® vs. SANTYL® within the ChronEx Phase II Randomized Controlled Study

https://finance.yahoo.com/news/mediwound-announces-positive-results-head-120000787.html

Results demonstrate superiority of EscharEx®, a bromelain-based gel vs. SANTYL®, a collagenase ointment, in wound debridement, promotion of granulation tissue, and time to wound closure in patients with chronic venous leg ulcers (VLU)

YAVNE, Israel, Feb. 12, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair today announced the results of head-to-head comparison analyses of EscharEx, the Company’s lead asset in development for chronic wounds, to collagenase SANTYL ointment, approved by the FDA for debriding chronic dermal ulcers. SANTYL is currently the market-leading enzymatic debridement product, with more than $360 million in estimated annual sales in the United States.

Results from the previously disclosed Phase II study (ChronEx) which evaluated the safety and efficacy of EscharEx, demonstrated the superiority of EscahrEx vs. a gel vehicle (placebo) and non-surgical standard of care (NSSOC), in achieving complete debridement of non-viable tissue and promotion of granulation tissue (healthy, highly vascularized tissue). The secondary analyses announced today assessed the incidence and time to complete debridement, complete granulation, and wound closure in patients treated with EscharEx (n=46) compared to a sub-group of patients who were treated with SANTYL (n=8).

Ofer Gonen, CEO of MediWound said, “These head-to-head results position EscharEx to become the market leader in enzymatic agents for the treatment of chronic wounds. Data from clinical studies show that EscharEx provides a multimodal mechanism of action for debridement and promotion of granulation tissue, as well as reduction of biofilm and bioburden. All are achieved within a short time frame to facilitate early wound closure, a major benefit for patients suffering from chronic non-healing wounds. With such promising Phase II data, we look forward to the upcoming Phase III trial, set to begin in the second half of 2024, as planned.”

Results highlights (EscharEx vs SANTYL)

Baseline characteristics (age, gender, wound age, wound size) were comparable in both groups.

The incidence of complete debridement during the daily treatment period (the first two weeks of the study) was 63.0% (95% CI=47.5-76.8) for EscharEx vs. 0% for SANTYL; p=0.001.

The estimated median time to achieve complete debridement during the study was 9 days (95% CI=5-15 days) for EscharEx vs. not achieved for SANTYL (95% CI=22-Not Applicable); p=0.023.

The incidence of achieving complete debridement and complete cover of the wound bed with granulation tissue (i.e., wound bed preparation, WBP) during the daily treatment period was 50.0% (95% CI = 34.9%-65.1%) for EscharEx vs. 0% for SANTYL; p=0.015.

The incidence of achieving WBP throughout the study was 78.3% (95% CI = 63.6-89.1) for EscharEx vs. 37.5% for SANTYL (95% CI=8.5-75.5); p=0.03.

The estimated median time to achieve WBP was 11 days (95% CI =7-50 days) for EscharEx vs. not achieved for SANTYL (95% CI=22-Not Applicable); p=0.014.

15 of the 46 patients (32.6%) treated with EscharEx completely closed their wounds during the study, compared to 2 out of 8 patients (25%) treated with SANTYL (NSS). In those patients who achieved complete wound closure, the average time to wound closure was 48.4 days (SD=23.5) for EscharEx vs. 76.0 days (SD=2.8) for SANTYL; p=0.05.

Patient reported applicational pain was comparable in both groups.

The safety profile and overall incidence of adverse wound reactions were comparable between arms.

Dr. Robert J. Snyder, Chief Medical Officer of MediWound added, “Complete debridement and complete granulation are key components of wound bed preparation, a critical step in the transition of a chronic wound from an abnormal, disrupted healing process to a normal healing process. These results further support the potential superiority of EscharEx compared with SANTYL in both the percentage of wounds achieving these critical steps, as well as the timeframe in which they are achieved. These significant differences could have a profound impact on wound healing, prevention of complications, and reduction in disease burden.”

The data is scheduled for 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).

About the ChronEx study

The ChronEx study was a Phase II multicenter, prospective, randomized, placebo controlled, adaptive design study that evaluated the safety and efficacy of a bromelain-based enzymatic debridement agent in debridement of Venous Leg Ulcers (VLUs).

In the ChronEx study, patients with chronic VLU were randomized (3:3:2 ratio) to daily treatment with EscharEx, placebo, or non-surgical standard of care (SOC), respectively, for up to 2 weeks or until reaching complete debridement and then treated with non-surgical SOC for 12 weeks. The non-surgical SOC arm included SANTYL®, hydrogels, medical grade honey, and non-active dressings.

About EscharEx

EscharEx is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds, currently in the advanced stages of clinical development. It is a concentrate of proteolytic enzymes enriched in bromelain for topical, easy to use daily applications. In several Phase II trials, EscharEx was shown to be safe, well-tolerated, and demonstrated its efficacy in debridement and promotion of granulation tissue in various hard-to-heal wounds, with only a few daily applications. EscharEx’s mechanism of action is mediated by proteolytic enzymes that cleave to and remove the necrotic tissue preparing the wound bed for healing. Phase III study in patients with VLU, is planned to start in the second half of 2024.

[midastouch017]

12.79+1.52 (+13.49%)
As of 01:14PM EST. Market open.
Volume 37,075
Avg. Volume 28,742

Nice!

[Monroe1]

Held for almost two years now. Sold half last month and the rest yesterday. Sell off is happening although I will most likely re-enter end of next month perhaps. It was quite amazing how the stock shot up even after the RS.

[2H2]

6x normal volume today. Finished red. Looks the the D word

[midastouch017]

Small wonder sp is up, check this piece:
NexoBrid commercial launch in the U.S., with over 50 burn centers submitting packages to Pharmacy and Therapeutics (P&T) committees and over 25 burn centers with P&T committee approvals.
Source:
https://finance.yahoo.com/news/vericel-announces-preliminary-full-fourth-125500829.html

[midastouch017]

12.31+0.41 (+3.44%)
As of 01:27PM EST. Market open.
Volume 72,469
Avg. Volume 18,458
Going places!

[midastouch017]

$1.1 million of NexoBrid® revenue

From https://finance.yahoo.com/news/vericel-announces-preliminary-full-fourth-125500829.html

[midastouch017]

MediWound Announces that FDA has Accepted for Review the Supplement to the NexoBrid BLA to Include Pediatric Patients with Severe Thermal Burns

https://finance.yahoo.com/news/mediwound-announces-fda-accepted-review-120000857.html

If approved, NexoBrid will serve as an effective non-surgical treatment for both pediatric and adult burn patients in the U.S.

NexoBrid is already approved for use for burn patients across all age groups in Europe and Japan

YAVNE, Israel, Jan. 09, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has completed their filing review and accepted a supplement to the NexoBrid® biologics license application (sBLA) for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns.

NexoBrid, a topically administered biological drug that enzymatically removes nonviable burn tissue, received FDA approval in the U.S. in December 2022 for eschar removal in adult patients with deep partial-thickness and/or full-thickness thermal burns.

The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages. It is based on the results of a global Phase 3 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 3 and Phase 2 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.

“The acceptance of the NexoBrid sBLA filing by the FDA marks an important milestone for MediWound and reinforces our commitment to redefine the standard of care for the treatment of severe burns across all age groups,” said Ofer Gonen, CEO of MediWound. “NexoBrid is already approved for the adult and pediatric populations in Europe and Japan, and we look forward to working with the FDA, alongside our partner Vericel, throughout the sBLA review process.”

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 in United States, European Union and Japan, where it has been designated as an orphan biologic drug.

NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT) in the U.S. Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

About MediWound

MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company 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 legacy drug 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 recently completed Phase I/II study.

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

[midastouch017]

11.74+0.49 (+4.36%)
As of 12:52PM EST. Market open.
Momentum continues.

[midastouch017]

This article explains:
11.25+1.08 (+10.62%)
At close: January 2 03:58PM EST
With relative robust volume:
Volume 60,798
Avg. Volume 16,539

[MadCityCyclone]

New Avenue of Wound Care

[midastouch017]

10.82+0.65 (+6.44%)
As of 02:14PM EST. Market open.
Volume 41,571
Avg. Volume 16,316
Nice!

[midastouch017]

MediWound Secures Additional U.S. Department of Defense Funding to Advance NexoBrid® Development for the U.S. Army

https://finance.yahoo.com/news/mediwound-secures-additional-u-department-120000363.html

Awarded additional $6.7 million to advance NexoBrid as a non-surgical field care solution; R&D project budget increased to $14.4 million

YAVNE, Israel, Dec. 28, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), has awarded MediWound an additional $6.7 million in non-dilutive funding to develop NexoBrid® as a non-surgical solution for field-care burn treatment for the U.S. Army (the "MTEC Research Project Award"). The $14.4 million project budget will advance the development and production of a new, temperature-stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings. Vericel Corporation holds an exclusive license encompassing the commercial and development rights to NexoBrid in North America as set forth in the license agreement between the Company and Vericel.

"We are delighted to further solidify our partnership with the U.S. Department of Defense. The additional funding will enhance our CMC activities, expedite preclinical development, and facilitate the establishment of a GMP compliant aseptic production line for the temperature-stable formulation of NexoBrid," announced Ofer Gonen, Chief Executive Officer of MediWound. "This new award underscores our shared commitment to ensuring NexoBrid's availability for military use and its potential to significantly change the early treatment approach for severe burns."

The MTEC Research Project Award was granted by the DoD’s U.S. Army Medical Research and Development Command (USAMRDC) and funded by the Defense Health Agency through MTEC, a biomedical technology consortium working to advance innovative medical solutions to keep military personnel healthy and fully operational. In alignment with this mission, it's vital to have field solutions for severe burn treatments that are both easy-to-use and effective. Such solutions should be applicable immediately post-injury and demand minimal preparation and training.

About U.S. Army Medical Research and Development Command (USAMRDC)
The U.S. Army Medical Research and Development Command is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical, and biological defense https://mrdc.health.mil/.

Please note, the views expressed in this press release are those of MediWound and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

About Medical Technology Enterprise Consortium (MTEC)
The Medical Technology Enterprise Consortium is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel. To find out more about MTEC, visit mtec-sc.org.

About MediWound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company 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 advantages over the $300 million monopoly legacy drug 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 recently completed Phase I/II study.

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

Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives, anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the U.S. food and Drug Administration or 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 product candidates; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic.

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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

MediWound Contacts:

Hani Luxenburg

Daniel Ferry

Chief Financial Officer

Managing Director

MediWound Ltd.

LifeSci Advisors, LLC

[e-mail]

[e-mail]

[midastouch017]

MediWound Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric Patients

https://finance.yahoo.com/news/mediwound-receives-positive-chmp-opinion-120000725.html

The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment for burn patients of all ages

YAVNE, Israel, Nov. 13, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently.

This positive opinion is based on the results of a global Phase 3 trial that evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients (CIDS study), funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. It is also supported by additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid.

The Phase 3 study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in the time to achieve complete eschar removal and a significant reduction in the wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars as measured by MVSS. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and a reduction in the need for autograft in deep partial burns, as well as a favorable trend in the reduction of blood loss during the eschar removal process. In addition, the study confirmed NexoBrid to be safe and well-tolerated for all ages.

“This significant milestone advances our goal to redefine the standard of care for the treatment of severe burns. The current standard, surgery, is extremely traumatic to both patients and their families. NexoBrid offers a safe, fast, and highly effective debridement alternative to surgery, minimizing blood loss and reducing the time required for treatment,” said Ofer Gonen, CEO of MediWound. He added, “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.”

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 in United States, European Union and Japan, where it has been designated as an orphan biologic drug.

NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT) in the U.S. Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

About MediWound

MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company 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 advantages over the $300 million monopoly legacy drug 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 recently completed Phase I/II study.

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

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, expectations and commercial potential of our products and product candidates, including NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated our expectations regarding future growth, market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2023 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

MediWound Contacts:



Hani Luxenburg

Daniel Ferry

Chief Financial Officer

Managing Director

MediWound Ltd.

LifeSci Advisors, LLC

[e-mail]

[e-mail]

[midastouch017]

MediWound Announces Collaboration with 3M on EscharEx® Phase III Study
https://finance.yahoo.com/news/mediwound-announces-collaboration-3m-escharex-100000502.html

MediWound to join forces with 3M Health Care, world’s largest wound care company in pivotal study for patients with venous leg ulcers

YAVNE, Israel, Oct. 11, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced collaboration with 3M Health Care. 3M Health Care will provide its market leading two-layer compression systems Coban™ 2 and Coban™ 2 Lite to be used during the debridement and wound healing phases of the EscharEx Phase III study.

"In our pursuit of excellence, one primary aim is to ensure consistency across subjects while delivering optimal care throughout the study. 3M Health Care's Coban™ compression systems stand out as global market leaders, and we're pleased to designate them as the standard for our Phase 3 study," commented Ofer Gonen, Chief Executive Officer of MediWound. "Given that compression therapy is pivotal in managing venous leg ulcers (VLUs), it's imperative that we employ top-tier products. With 3M Health Care’s two-layer compression systems, we're confident we're doing just that."

EscharEx is being evaluated for efficacy and safety in the debridement of chronic wounds, with the first indication being VLUs. During the debridement phase, as well as in the wound healing phase of the study, 3M’s two-layer compression systems will be used as standard of care in all study arms, until the wounds reach complete healing.

"We are excited to partner with MediWound on this pivotal Phase III study. Establishing Coban™ 2 and Coban™ 2 Lite as the benchmark in compression therapy underscores the brand's leadership and reinforces its position as the top choice for VLU patients," said Rob Steel, Global Portfolio Director at 3M Health Care. "We anticipate leveraging the comprehensive data from the study to convey to clinicians and payors the clinical and economic advantages of our compression systems."

About EscharEx

EscharEx® (concentrate of proteolytic enzymes enriched in bromelain) is a topical biologic drug applied daily that enzymatically removes nonviable wound tissue, or eschar, in patients with chronic wounds without harming viable tissue. EscharEx has been the subject of 3 successful Phase 2 studies, and is entering into a global Phase III study in early 2024. Co-primary endpoints in the study are incidence of complete debridement and time to complete wound closure. Secondary endpoints include time to complete debridement, incidence of complete granulation tissue, incidence of complete wound closure and wound area reduction.

About 3M

3M (NYSE: MMM) believes science helps create a brighter world for everyone. By unlocking the power of people, ideas and science to reimagine what's possible, our global team uniquely addresses the opportunities and challenges of our customers, communities, and planet. Learn how we're working to improve lives and make what's next at 3M.com/news or on Twitter at @3M or @3MNews.

About MediWound Ltd.

MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company 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 advantages over the $300 million monopoly legacy drug 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 recently completed Phase I/II study.

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

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; the impact of the COVID-19 pandemic, our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2023 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

MediWound Contacts:

Hani Luxenburg

Daniel Ferry

Chief Financial Officer

Managing Director

MediWound Ltd.

LifeSci Advisors, LLC

[e-mail]

[e-mail]

[midastouch017]

MediWound Deploys NexoBrid® for Emergency Supply

https://finance.yahoo.com/news/mediwound-deploys-nexobrid-emergency-supply-113400584.html

YAVNE, Israel, Oct. 09, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, addresses emergency demand for NexoBrid to treat the mass of burn casualties, inflicted by the war in Israel.

Hospitals and military forces have urgently requested NexoBrid supplies. To address this critical need, MediWound has deployed all its available NexoBrid inventory to aid the substantial number of burn victims.

MediWound remains committed to fulfilling its obligations to our global markets and is implementing measures to ensure supply continuity.

About NexoBrid

NexoBrid® (anacaulase-bcdb) 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 in the United States, European Union and Japan, where it has been designated as an orphan biologic drug. Development of NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

[midastouch017]

Vericel Announces Publication of Positive Results from Phase 3 Debride and Protect (DETECT) Study of Thermal Burn Patients Treated with NexoBrid

https://finance.yahoo.com/news/vericel-announces-publication-positive-results-123000746.html

Data published in the Journal of Burn Care & Research show treatment with NexoBrid resulted in early complete eschar removal in more than 90% of treated patients, and reduced surgery when compared to Gel Vehicle and standard of care

Results demonstrate that NexoBrid is safe and well-tolerated without deleterious effects on wound closure and scarring

CAMBRIDGE, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the recent publication of results from the Phase 3 DETECT study assessing the safety and efficacy of NexoBrid® (anacaulase-bcdb) in the Journal of Burn Care & Research.

“These data demonstrate the ability of NexoBrid to provide patients with severe thermal burns safe and effective enzymatic eschar removal that is superior to current debridement methods,” said Dr. Jon Hopper, Chief Medical Officer of Vericel. “We are pleased that NexoBrid is now available to U.S. burn surgeons to treat severe burn patients and we believe the publication of these results, coupled with real-world clinical experience, will help establish NexoBrid as the new standard of care for eschar removal.”

The three-arm DETECT study consisted of 175 adult patients with deep thermal burns covering 3-30% of total body surface area, who were randomized to NexoBrid, surgical or non-surgical standard of care (SOC), or placebo Gel Vehicle (GV) treatment arms in a 3:3:1 ratio. The primary endpoint was complete eschar removal at the end of the debridement phase and secondary outcomes were the need for surgery and time to complete eschar removal. Key findings include:

More than 93% of the patients treated with NexoBrid achieved complete eschar removal following one application of NexoBrid compared with 4% in the GV arm (P<0.0001);

Surgical excision was lower in the NexoBrid arm when compared to the SOC group (4% vs. 72%; P<0.001);

The estimated median time to complete eschar removal was 1.02 and 3.83 days for the NexoBrid and SOC treatment arms, respectively (P<0.0001); and

NexoBrid appeared safe and well tolerated without deleterious effects on wound closure and scarring.

Data from this study ultimately served as the foundation for the FDA approval of NexoBrid for commercial use in the U.S.

About NexoBrid
NexoBrid (anacaulase-bcdb) is a botanical drug product containing proteolytic enzymes indicated for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns. To learn more about NexoBrid, please visit www.NexoBrid-US.com.

About Vericel Corporation
Vericel is a leader in advanced therapies for sports medicine and severe burn care. The Company manufactures and markets two cell therapy products and one specialty biologic product in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel also holds an exclusive license for North American rights to NexoBrid® (anacaulase-bcdb), a biological orphan product containing proteolytic enzymes, which is indicated for the removal of eschar in adults with deep partial-thickness and/or full-thickness burns. For more information, please visit www.vcel.com.

Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2023 Vericel Corporation. All rights reserved.

Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Vericel’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Investor Contact:
Eric Burns
[e-mail]
[phone]

Media Contact:
Julie Downs
[e-mail]