[realfast95]

Shipped NexoBrid finished product to Vericel for the U.S. commercial launch in June 2023. However, Vericel is unable to commercially release the product at this time due to a deviation associated with a third-party testing lab used during the manufacturing process. MediWound and Vericel are actively engaged with the U.S. Food and Drug Administration (FDA) to address this matter. Future production lots will not be impacted by this process deviation issue. Vericel expects to begin commercial sales of NexoBrid from a scheduled September 2023 production run, during the first quarter of 2024. MediWound believes that a possible delay in the U.S. launch, will not have an impact on NexoBrid revenues for the years 2023-2024.

[midastouch017]

We look forward to building on this momentum as we expect a further acceleration in
total company revenue growth in 2024 driven by the planned launch of arthroscopic
MACI and a significant contribution from NexoBrid.”

https://finance.yahoo.com/news/vericel-reports-second-quarter-2023-115500944.html

[midastouch017]

MediWound Announces Commercial Launch of NexoBrid® in Japan

https://finance.yahoo.com/news/mediwound-announces-commercial-launch-nexobrid-113000020.html

Kaken Pharmaceutical launches NexoBrid under an exclusive marketing and distribution agreement

YAVNE, Israel, Aug. 01, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that its strategic partner, Kaken Pharmaceutical Co. Ltd, launched NexoBrid® in Japan for the treatment of deep partial thickness and full thickness burns in adults and pediatric patients. Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive marketing and distribution rights for NexoBrid in Japan.

NexoBrid is indicated for the removal of eschar in deep partial and full thickness thermal burns. The current standard of care is primarily based on non-selective, expensive, and potentially disfiguring surgical excisions. NexoBrid offers burn specialists with an alternative of a single 4-hour topical treatment, after which the dissolved eschar is removed, leaving a clean wound bed ready for healing.

“As one of the top healthcare markets worldwide, Japan holds special strategic importance. Over 6,000 patients are treated for severe burns in Japan every year, with a majority of these patients undergoing eschar removal as a critical first step. NexoBrid can now be a non-surgical treatment option for these patients,” stated Ofer Gonen, Chief Executive Officer of MediWound. “We are proud to have Kaken Pharmaceutical, a trusted and valuable partner, leading the commercialization of NexoBrid in this key market. Kaken Pharmaceutical is a major drug manufacturer in Japan with a unique core marketing competency for both drugs and medical devices, which is critical in promoting a product like NexoBrid.”

Hiroyuki Horiuchi, President and Representative Director of Kaken Pharmaceutical stated, “We are excited to introduce this drug to the Japanese market. The prospects are excellent for it becoming the new standard-of-care for serious and life-threatening burns, bringing significant benefits to providers and patients alike. Given our long-term relationship with MediWound, we have been anticipating this moment. Our experience selling products in the burn treatment area along with our existing relationships in the hospital systems prepares us to transform NexoBrid into the standard of care for severe burns.”

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Turnkey Scale-up Agreement

On July 17, 2023, MediWound Ltd. (the “Company”) signed a turnkey scale-up agreement (the “Scale-up Agreement”) with Biopharmax Group Ltd. This strategic agreement is designed to bolster our manufacturing infrastructure to support our long-term growth trajectory. 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 our production capacity significantly, projected to expand to six times the current capacity, aligning with our 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.

The Scale-up Agreement encompasses various standard provisions, including those related to reporting, compliance, guarantees, representations, liability, insurance, confidentiality, and ownership. The foregoing description of the Scale-up Agreement for New Facility does not purport to be complete and is qualified in its entirety by reference to the full text of such Agreement, a copy of which will be filed as an exhibit to the Company’s next Annual Report on Form 20-F.

Long-term Lease Agreement

Alongside entering the Scale-up Agreement, we have also secured a new lease agreement (the “Lease Agreement”) with the current property owner. This agreement allows us to continue the utilization of our existing facilities and the planned manufacturing site. This property, located in Yavne, Israel, serves as the base for our administrative headquarters, research and development laboratories, and manufacturing plant. The duration of the lease extends until 2035, with an option for a further three-year extension until 2038.

The property, measuring approximately 32,500 square feet, will encompass the new manufacturing facility. As per the Lease Agreement, our annual rent is set at approximately $625,000. This rent is indexed to the Israeli Consumer Price Index and will see a staged increase of 6% every three years.

The foregoing description of the Lease Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Lease Agreement, a copy of which will be filed as an exhibit to the Company’s next Annual Report on Form 20-F.

[midastouch017]

MediWound Announces Positive Results in Its U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma

https://finance.yahoo.com/news/mediwound-announces-positive-results-u-113000455.html

MW005 shown to be safe and well-tolerated

Data provide clinical efficacy proof-of-concept based on clearance of target lesions

YAVNE, Israel, July 10, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced positive data from its Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data show MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions.

The Phase I/II study is an open-label, multi-centered, randomized clinical trial designed to evaluate the safety and efficacy of MW005 in patients with BCC. All of the patients enrolled in the study had histologically confirmed superficial or nodular BCC. Enrolled patients received seven topical applications of MW005 once every other day for fourteen days. Eight weeks following the last treatment, all patients underwent a complete excisional biopsy. The excised specimen was subjected to an independent histological clearance examination. The study’s endpoints include safety and tolerability measurements, as well as efficacy assessments, as measured by the proportion of patients who reach clinically and histologically confirmed complete clearance.

Fifteen patients were treated with MW005 and completed the study. Results showed MW005 to be safe and well-tolerated, with a high level of patient compliance. While the primary focus of the trial was on safety and tolerability, it is worth noting that based on clinical assessments, eleven out of fifteen patients achieved complete clearance of their BCCs; the majority of these patients also had histologically confirmed complete clearance. Data comprising clinical and histological outcomes, supported by extensive patient follow-up, will be featured at an upcoming scientific conference in 2023.

These results corroborate the previous proof-of-concept study published by Prof. Rosenberg et al (Basal Cell Carcinoma Destruction by a Concentrate of Proteolytic Enzymes Enriched in Bromelain: A Preliminary Report; TODJ-15-39, 2021), where seven BCC tumors treated with MW005 were completely removed based on clinical assessment, and none reoccurred over the subsequent 24 months.

“Most low-risk BCCs are treated surgically. There is a clear unmet need for an effective, non-surgical, topically-applied, short duration treatment for low-risk BCC, with a superior tolerability profile, with less severe local skin reactions associated with current topical therapies,” said Dr. Brian Berman, past president of American Dermatological Association, Professor Emeritus, University of Miami, and a lead principal investigator of the Phase I/II study. “These encouraging results from the clinical study of MW005 suggest that we are headed in the right direction and on track for a possible solution.”

Ofer Gonen, CEO of MediWound, said, "These data further validate the potential of MW005 as a significant advancement in cancer treatment. BCC affects two to three million individuals in the U.S. each year, and we believe MW005 may reduce the reliance on expensive and potentially disfiguring surgical procedures in certain cases, thereby improving patient experiences and outcomes."

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 MW005. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the 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.

Contacts:







Hani Luxenburg

Monique Kosse

Chief Financial Officer

Managing Director, LifeSci Advisors

MediWound Ltd.

212-915-3820

[e-mail]

[e-mail]

[midastouch017]

MediWound Receives Positive Scientific Advice from European Medicine Agency (EMA) on EscharEx Phase III Study Design

https://finance.yahoo.com/news/mediwound-receives-positive-scientific-advice-110000569.html

Affirms the clear path forward for the Company’s global Phase III study of EscharEx in venous leg ulcers

YAVNE, Israel, July 03, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced it has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) related to the development plan for the company’s Phase III study of EscharEx in the treatment of Venous Leg Ulcers (VLUs) and to the overall data required for subsequent potential marketing authorization submission and commercialization.

The CHMP notified the company that it concurs with the overall design of the proposed study, including its objectives, choice of study arms, patient population, inclusion/exclusion criteria, standardization of treatment, proposed primary, secondary, and safety endpoints and study duration. Additionally, the CHMP indicated that it can accept one confirmatory study in VLU patients as the basis for approval, assuming the data are robust and similar to the company’s previous studies.

"We are very pleased to receive positive Scientific Advice from EMA supporting our Phase III development plan for EscharEx. The constructive feedback we have garnered from both the U.S. Food and Drug Administration (FDA) and the EMA provides consensus, empowering us to conduct this pivotal Phase III study on a global scale,” said Ofer Gonen, Chief Executive Officer of MediWound. “EscharEx addresses an important medical need for patients suffering from chronic wounds, and we look forward to bringing this next-generation therapy to market.”

In this initial indication for EscharEx, VLUs affect approximately 560,000 patients annually with an estimated $1 Billion market in the U.S. alone. The Phase III study will be a global, multi-center, prospective, randomized, placebo-controlled trial in approximately 244 patients, who will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications lasting 24 hours each. Patients will then be followed weekly for up to 10 weeks, during which time they will be treated with standard of care (SOC). Patients who achieve wound closure confirmation will continue for an additional 10-week follow-up. The co-primary endpoints are the incidence of complete debridement at the end of the daily visit period, and time to achieve wound closure. EscharEx uses the same active pharmaceutical ingredient (API) as the NexoBrid®, which has been approved for debridement of thermal burns in the U.S. and Europe.

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 biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. Additionally, MediWound has a Phase I/II biologic for basal cell carcinoma, MW005, with results expected in Q3 2023.

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

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

Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 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.

Investor Contacts:

Hani Luxenburg
Chief Financial Officer
MediWound, Ltd.
[e-mail]

Monique Kosse
Managing Director, LifeSci Advisors
[phone]
[e-mail]

[midastouch017]

MediWound Reports First Quarter 2023 Financial Results and Provides a Company Update
https://finance.yahoo.com/news/mediwound-reports-first-quarter-2023-110000957.html

On track to initiate EscharEx® Phase III study in fourth quarter 2023
NexoBrid® U.S. launch expected in early third quarter 2023
Cash of over $57 million; Operating cash runway through profitability

Conference call begins today at 8:30 a.m. Eastern Time

YAVNE, Israel, May 30, 2023 (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, 2023 and provided a corporate update.

"This quarter has been extremely productive as our dedicated team has worked diligently to advance the key components of our strategic plan. The outcomes of our focused efforts are evident, as we are on track to initiate the Phase III study for our flagship product, EscharEx, in the fourth quarter of this year. This represents a significant commercial opportunity and addresses a major unmet need. Furthermore, we are excited to partner with Vericel for the upcoming U.S. launch of NexoBrid. Simultaneously we are making rapid progress in our manufacturing scale-up plan to meet the surging global demand. Importantly, MediWound is now in a strong financial position, with over $57 million in cash. This provides the company with ample resources to effectively execute its corporate initiatives and drive continuous innovation," stated Ofer Gonen, Chief Executive Officer of MediWound.

First Quarter 2023 Highlights and Recent Developments:

The Company’s global Phase III clinical study for EscharEx is expected to begin in the fourth quarter of 2023. The pivotal trial protocol is aligned with feedback from the U.S. Food and Drug Administration (FDA); protocol feedback from the European Medicines Agency (EMA) anticipated in mid-year 2023. This multicenter, prospective, randomized, placebo-controlled trial aims to evaluate the safety and efficacy of EscharEx in patients with venous leg ulcers (VLUs). Approximately 244 patients will be randomized to either EscharEx or gel vehicle (placebo control) in a 1:1 ratio. The treatment protocol will include a daily visit period of up to 14 days, during which EscharEx or gel vehicle will be applied once a day for a maximum of 8 applications. Patients will be followed for up to 22 weeks after treatment, during which all patients will be treated with standard of care. The co-primary endpoints are the incidence of complete debridement at the end of the daily visit period, and time to achieve wound closure.

Initiated the expansion of the Company’s manufacturing facility to address the increasing global demand for NexoBrid. This expansion project is scheduled for completion by the end of 2024 and will increase production capacity by five-fold. The Company is dedicated to ensuring the availability of NexoBrid, particularly in the United States, the largest market for this product.

Received a $7.5 million milestone payment from Vericel, triggered by the FDA’s approval of NexoBrid for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns. NexoBrid commercial launch in the U.S. is planned for early third quarter 2023.

Announced the award of an additional $10 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) to support the $3 million replenishment of expired product previously procured for emergency preparedness, the pediatric indication sBLA submission to the U.S. FDA, and enrollment of an additional 50 patients in the ongoing expanded access treatment protocol (NEXT).

Strengthened its management team with the addition of highly experienced executives. The Company welcomed Hani Luxenburg as its new Chief Financial Officer, Barry Wolfenson as Executive Vice President of Strategy and Corporate Development, and Alicia Torrenova as Vice President of European Operations.

Raised gross proceeds of $27.5 million in a registered direct offering of ordinary shares, with participation from new and current institutional shareholders, including top-tier investors such as Point 72, Israel Biotech Fund, Deep Insight and aMoon.

Cash and short-term investments of $57.4 million as of March 31, 2023.

First Quarter 2023 Financial Highlights

Total revenues were $3.8 million, compared to $4.4 million for the first quarter of 2022. Revenues from development services were $2.6 million, compared to $3.1 million in the first quarter of 2022. This decrease was primarily attributed to the NexoBrid approval in December 2022. Revenues from products were $1.2 million, compared to $1.1 million in the first quarter of 2022.

Gross profit was $0.8 million, or 22% of the total revenue, compared to a gross profit of $1.5 million, or 33% of the total revenue, for the first quarter of 2022. The decrease in gross profit was primarily due to changes in the revenue mix and nonrecurring production costs.

Research and development expenses were $2.1 million, compared to $2.4 million in the first quarter of 2022.

Selling, general and administrative expenses were $3.1 million, compared to $2.3 million in the first quarter of 2022. The increase was primarily due to the addition of personnel to support future growth, along with share-based compensation expenses.

Operating loss was $4.4 million, compared to a loss of $3.3 million in the first quarter of 2022.

The Company posted a net loss of $3.7 million, or $0.44 per share, compared to a net loss of $3.6 million, or $0.87 per share, for the first quarter of 2022.

Adjusted EBITDA, as defined below, was a loss of $3.4 million, compared to a loss of $2.6 million for the first quarter of 2022.

As of March 31, 2023, the Company had $57.4 million in cash and short-term investments, compared with $34.1 million as of December 31, 2022. The Company utilized $1.8 million to fund its operating activities in the first quarter of 2023. Existing cash and cash equivalents are expected to provide sufficient funds for the Company’s current operating plan through profitability.

Conference Call

MediWound management will host a conference call for investors today, Tuesday, May 30, 2023, 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. 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 biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. The Phase III study is expected to start in Q4 2023. Additionally, MediWound has a Phase I/II biologic for basal cell carcinoma, MW005, with results expected in Q3 2023.

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

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 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.

Contacts:









Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
[e-mail]







Monique Kosse
Managing Director, LifeSci Advisors
212-915-3820
[e-mail]



MediWound Ltd.

CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITIONS

U.S. dollars in thousands





March 31,



December 31,





2023



2022



2022





Un-audited



Audited

Cash, cash equivalents



51,020



16,651



33,895

Restricted deposits



-



185

-

Short-term bank deposits



6,184



-

-

Trade receivables



2,520



2,348



9,332

Inventories



2,536



1,920



1,963

Other receivables



1,011



852



650

Total current assets



63,271



21,956



45,840















Trade and other receivables



305



230



364

Property, plant and equipment, net



3,724



2,471



2,366

Right of use assets, net



1,151



1,429



1,215

Intangible assets, net



215



281



231

Total non-current assets



5,395



4,411



4,176















Total assets



68,666



26,367



50,016















Current maturities of long-term liabilities



2,139



2,572



2,242

Trade payables and accrued expenses



3,403



5,623



5,656

Other payables



3,722



3,055



4,159

Total current liabilities



9,264



11,250



12,057















Deferred revenues



-



91



-

Warrants, net



14,674



-



15,606

Liabilities in respect of IIA grants



7,580



7,897



7,445

Liabilities in respect of TEVA



2,660



3,642



2,788

Lease liabilities



743



1,239



846

Severance pay liability, net



445



303



360

Total non-current liabilities



26,102



13,172



27,045















Shareholders' equity



33,300



1,945



10,914

Total liabilities & shareholder equity



68,666



26,367



50,016



MediWound Ltd.

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands



Three months ended





Year ended



March 31,





December 31,



2023





2022







2022

















Revenues

3,799





4,407







26,496



Cost of revenues

2,973





2,947







13,331



Gross profit

826





1,460







13,165



Operating expenses:













Research and development

2,102





2,408







10,181



Selling, general and administrative

3,088





2,336







10,645



Other expenses, net

-





-







684



Operating loss

(4,364)





(3,284)







(8,345)

















Financial income (expenses), net

676





(301)







(11,176)



Loss before taxes on income

(3,688)





(3,585)







(19,521)



Taxes on income

(5)





(4)







(78)



Net loss

(3,693)





(3,589)







(19,599)

















Foreign currency translation adjustments

(9)





5







14



Total comprehensive loss

(3,702)





(3,584)







(19,585)

















Basic and diluted loss per share:













Net loss per share

(0.44)





(0.87)







(3.93)



Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:

8,388





4,105







4,987





MediWound Ltd.

ADJUSTED EBITDA

U.S. dollars in thousands



Three months ended



Year ended





March 31,



December 31,



2023



2022



2022

Loss for the period

(3,693)



(3,589)



(19,599)

Adjustments:











Financial income (expenses), net

676



(301)



(11,176)

Other expenses, net

-



-



(684)

Tax expenses

(5)



(4)



(78)

Depreciation and amortization

(303)



(321)



(1,272)

Share-based compensation expenses

(619)



(345)



(1,946)

Total adjustments

(251)



(971)



(15,156)

Adjusted EBITDA

(3,442)



(2,618)



(4,443)



MediWound Ltd.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED)

U.S. dollars in thousands



Three months ended



Year Ended

March 31,



December 31,



2023





2022





2022



Cash Flows from Operating Activities:











Net loss

(3,693)





(3,589)





(19,599)















Adjustments to reconcile net loss to net cash provided by (used in) operating activities:











Adjustments to profit and loss items:











Depreciation and amortization

303





321





1,272



Share-based compensation

619





345





1,946



Revaluation of warrants accounted at fair value

(932)





-





8,977



Issuance expenses of warrants through profit and loss

-





-





1,911



Revaluation of contingent liabilities in respect of IIA grants

259





234





(132)



Revaluation of liabilities in respect of TEVA

122





137





533



Revaluation of lease liabilities

(13)





(14)





(109)



Increase in severance liability, net

77





20





109



Net financing income

(246)





-





(74)



Un-realized foreign currency loss

345





245





525





534





1,288





14,958



Changes in asset and liability items:











Decrease (Increase) in trade receivables

6,822





(579)





(7,582)



Increase in inventories

(583)





(710)





(721)



Decrease (Increase) in other receivables

(313)





125





364



Increase (Decrease) in trade payables & accrued expenses

(1,948)





283





414



Increase (Decrease) in other payables & deferred revenues

(167)





(883)





281





3,811





(1,764)





(7,244)



Net cash provided by (used in) operating activities

652





(4,065)





(11,885)















Cash Flows from Investment Activities:











Purchase of property and equipment

(1,505)





(160)





(555)



Interest received

302





-





74



Investment in short term bank deposits, net

(6,240)





-





-



Net cash used in investing activities

(7,443)





(160)





(481)















Cash Flows from Financing Activities:











Repayment of lease liabilities

(177)





(178)





(701)



Repayment of liabilities in respect of TEVA

(417)





-





(1,667)



Repayment of contingent liabilities in respect of IIA grants

(310)





(162)





(258)



Proceeds from issuance of shares and warrants, net

25,157





10,417





38,390



Net cash provided by financing activities

24,253





10,077





35,764















Exchange rate differences on cash and cash equivalent balances

(337)





(247)





(549)



Increase in cash and cash equivalents

17,125





5,605





22,849



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

33,895





11,046





11,046



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

51,020





16,651





33,895

[midastouch017]

MediWound Q1 Earnings Preview

May 26, 2023 1:59 PM ETMediWound Ltd. (MDWD)

By: Urvi Shah, SA News Editor

MediWound (NASDAQ:MDWD) is scheduled to announce
Q1 earnings results on Tuesday, May 30th, before market open.

The consensus EPS Estimate is -$0.43 (-258.3% Y/Y) and
the consensus Revenue Estimate is $5.15M (+17.0% Y/Y).

[midastouch017]

MediWound Ltd. (NASDAQ:MDWD) Short Interest Down 9.4% in April

Posted by Defense World Staff on May 16th, 2023

https://www.defenseworld.net/2023/05/16/mediwound-ltd-nasdaqmdwd-short-interest-down-9-4-in-april.html

MediWound logoMediWound Ltd. (NASDAQ:MDWD – Get Rating) saw a large decline in short interest in the month of April. As of April 30th, there was short interest totalling 61,900 shares, a decline of 9.4% from the April 15th total of 68,300 shares. Based on an average trading volume of 25,700 shares, the days-to-cover ratio is currently 2.4 days. Approximately 1.0% of the shares of the company are sold short.

Analyst Ratings Changes

A number of research analysts recently issued reports on the company. HC Wainwright reiterated a “buy” rating and set a $23.00 price objective on shares of MediWound in a research note on Friday, March 17th. StockNews.com initiated coverage on MediWound in a research note on Thursday, March 16th. They set a “hold” rating for the company. One research analyst has rated the stock with a hold rating and five have given a buy rating to the company’s stock. Based on data from MarketBeat, the stock presently has a consensus rating of “Moderate Buy” and a consensus target price of $38.25.

[midastouch017]

MediWound to Report First Quarter 2023 Financial Results

https://finance.yahoo.com/news/mediwound-report-first-quarter-2023-120000869.html

Fri, May 12, 2023 at 3:00 PM GMT+3

Conference Call and Webcast Scheduled for Tuesday, May 30th at 8:30 am Eastern Time

YAVNE, Israel, May 12, 2023 (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 first quarter ended March 31, 2023 on Tuesday, May 30, 2023.

Following the release, MediWound's management will host a conference call and live webcast at 8:30am 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

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.

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 biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. The Phase III study is expected to start in Q4 2023. Additionally, MediWound has a Phase I/II biologic for basal cell carcinoma, MW005, with results expected in Q3 2023.

[midastouch017]

Tracking ahead of initial goals on NexoBrid® Pharmacy and Therapeutics (P&T) committee submissions and approvals at target burn centers

NexoBrid selected for inclusion in the pre-conference healthcare professional educational sessions at the upcoming American Burn Association (ABA) annual meeting with hands-on lab demonstrations by leading burn surgeons

https://finance.yahoo.com/news/vericel-reports-first-quarter-2023-115500541.html

[midastouch017]

MediWound Announces an Additional $10 Million Award from BARDA

https://finance.yahoo.com/news/mediwound-announces-additional-10-million-113000753.html

Funding to support emergency stockpiling replenishment, pediatric indication submission, and expanded access treatment protocol extension

YAVNE, Israel, May 09, 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 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 (HHS), has awarded an additional $10 million to MediWound. The supplemental funding will support a $3 million replenishment of expired product previously procured for emergency preparedness, the pediatric indication sBLA submission to the U.S. Food and Drug Administration (FDA), and enrollment of an additional 50 patients in the ongoing expanded access treatment protocol (NEXT).

"Our long-standing partnership with BARDA has been instrumental in NexoBrid’s successful development. We are thrilled at the prospect of making it available in the U.S. market," said Ofer Gonen, Chief Executive Officer of MediWound. “Replenishment of the NexoBrid emergency stockpile highlights the critical importance of the product and ensures that in the event of a mass casualty burn incident, patients in the U.S. will have access to this lifesaving agent in a timely manner. We remain committed to advancing innovative solutions that will meet medical needs and improve patient outcomes."

The NexoBrid® indication expansion will include treatment of pediatric burn victims, which comprises more than 30% of the total burn population. NexoBrid is particularly relevant to the pediatric population as the current surgical standard of care (SOC) is extremely traumatic. NexoBrid enables clinicians to provide a safe, fast, and highly effective non-surgical debridement option that addresses the unmet need in the pediatric population.

The NEXT protocol provides for continued access to NexoBrid for up to 250 patients (in both the pediatric and adult populations), while maintaining physician skills until NexoBrid is commercially available in the U.S. for adults, and prior to receiving FDA approval for the pediatric indication.

MediWound was awarded its first BARDA contract for treatment of thermal burn injuries in 2015. This contract, now valued at up to $175 million, supported advanced development and manufacturing, as well as the procurement of NexoBrid as a medical countermeasure as part of U.S. emergency preparedness for a mass casualty. Under that contract, BARDA provided technical assistance and a total of up to $98 million for NexoBrid development activities required for U.S. marketing approval from the FDA. These activities include the NexoBrid Phase 3 study (DETECT) and subsequent BLA resubmission requirements, the pediatric Phase 3 study (CIDS), and the NexoBrid expanded access treatment protocol (NEXT). In January 2020, BARDA committed an additional $16.5 million to procure NexoBrid as part of the HHS mission to build national preparedness for public health medical emergencies. The contract further includes a $10 million option to fund development of other potential NexoBrid indications, and an option to procure additional NexoBrid valued at up to $47 million.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201500035C.

BARDA also has a separate contract of up to $41 million to support MediWound in the development of NexoBrid as a debridement agent for sulfur mustard cutaneous burns in both pediatric and adult indications.

The cumulative, non-dilutive funding under both contracts with BARDA is now valued at up to $216 million. As of December 31, 2022, the company has received approximately $82 million, in aggregate, from BARDA under the two contracts to support development activities and an additional $16.5 million for procurement of NexoBrid for U.S. emergency preparedness.

About MediWound Ltd.
MediWound Ltd. (Nasdaq: MDWD), a biopharmaceutical company, is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. With a 20+ year history 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®, an FDA-approved orphan biologic for eschar removal in severe burns, can replace the current standard of care which is costly surgical interventions, while minimizing the complications associated with them. Utilizing the same biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline. This includes the Company’s primary focus product under development, EscharEx®. EscharEx is a Phase III biologic for debridement of chronic wounds, with significant advantages over the $300+mm monopoly legacy drug and an opportunity to expand the market. The Phase III study is expected to start in Q4 2023. Additionally, the company has a Phase I/II biologic for basal cell carcinoma, MW005, with results expected in Q3 of 2023.

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 use of funds received from BARDA, the exercise of the replenishment option anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates including NexoBrid® and EscharEx®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; 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 prospectus supplement, the 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, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

Contacts:



Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
[e-mail]

Monique Kosse
Managing Director, LifeSci Advisors
212-915-3820
[e-mail]