SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
______________________
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934
For the month of August 2024
Commission File Number: 001-36349
MediWound
Ltd.
(Translation of registrant’s name into English)
42 Hayarkon Street
Yavne, 8122745 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒
Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): __
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): __
EXPLANATORY NOTE
On August 5, 2024, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound announces positive results from the U.S. NexoBrid® Expanded Access Protocol
(NEXT)”. A copy of this press release is attached to this Report of Foreign Private Issuer on Form 6-K (this “Form 6-K”) as Exhibit 99.1.
The content of this report on Form 6-K (including the information contained in Exhibit 99.1, but excluding quotes of senior management of the Company), is hereby incorporated by
reference into the Company’s Registration Statements on Form S-8 filed with the SEC on April 28, 2014, March 24, 2016, March 19, 2018, March 25, 2019, February 25, 2020, May 15, 2021 August 9, 2022 and August 15, 2023 (Registration Nos. No.
333-195517, 333-210375, 333-223767, 333-230487, 333-236635, 333-255784, 333-266697 and 333-273997, respectively) and on Form F-3 filed with the SEC on May 25, 2022 and March 31, 2023 (Registration Nos. 333-265203 and 333-268297, respectively).
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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MEDIWOUND LTD.
By: /s/ Hani Luxenburg
Name: Hani Luxenburg
Title: Chief Financial Officer
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EXHIBIT INDEX
The following exhibit is filed as part of this Form 6-K:
MediWound Announces Positive Results from the U.S. NexoBrid®
Expanded Access Protocol (NEXT)
NEXT Confirms NexoBrid's Proven Safety and Efficacy in Eschar Removal, Significantly Reducing
Surgical Procedures for Burn Patients
YAVNE, Israel, August 5, 2024 --
MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous
availability of NexoBrid® in burn centers until its commercialization. This program successfully maintained physician expertise, provided burn victims with ongoing access to this life-saving treatment, and facilitated the accumulation of
real-world safety and clinical data for NexoBrid.
Jeremy Goverman, MD, FACS, Associate Professor of Surgery at Harvard Medical School, commented, “The NEXT results reaffirm the
significant benefits of NexoBrid in managing severe burns. This enzymatic debridement agent accelerates the debridement process and reduces the need for surgical interventions, ultimately enhancing patient outcomes. The findings from NEXT are
consistent with data from the DETECT and CIDS Phase III trials, reinforcing the critical role that NexoBrid should play in standard burn care protocols.”
NEXT, an open-label, single-arm treatment protocol was conducted at 29 burn centers across the U.S. 239 patients, including 215 adults
and 24 children, with deep partial and full-thickness thermal burns covering up to 30% of the total body surface area (TBSA) were treated with NexoBrid.
Key Results of the NEXT Protocol Include:
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Efficacy (findings were consistent with Phase III studies
results):
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94.9% of adults and 100% of children achieved complete debridement.
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Only 4.2% of adults required surgical excision for eschar removal after NexoBrid treatment, and none in the pediatric group.
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The mean (± SD) percent of wound area surgically excised for adults was 3.6% (±18.33), and 0% for children.
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The time to complete eschar removal was less than one day for both adults and children.
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Healing and Hospitalization:
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The median time to wound closure was 22 days (95% CI: 22, 23) for adults and 28 days (95% CI: 18, 32) for children.
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The median time of hospitalization duration was 10 days (95% CI: 8, 11) for adults and 10 days (95% CI: 5, 14) for children.
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Safety: The safety data was consistent with the established
safety profile of NexoBrid, and no new safety concerns were identified by the Data Safety and Monitoring Board (DSMB).
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Benefit-Risk Ratio: The overall benefit-to-risk ratio of NexoBrid
treatment remains favorable.
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NexoBrid® is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in
patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid® is approved in over 40 countries, including the United States, European Union, and Japan. It has been designated as an orphan
biologic drug in all these territories.
NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical
study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access protocol
(NEXT). Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market
adoption in the United States.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The
Company specializes in the development, production and commercialization of rapid and effective biologics that improve existing standards of care and patient experiences, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA and EMA-approved orphan biologic for eschar removal in deep partial-thickness
and/or full-thickness thermal burns, which can significantly reduce surgical interventions. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline, including the company’s lead drug
under development, EscharEx®. EscharEx is a Phase III-ready biologic for the debridement of chronic wounds, offering significant potential advantages over the dominant $360+ million product and an opportunity to expand the market.
For more information visit www.mediwound.com
and follow the Company on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all
statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we
believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which
are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always,
made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or
conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions. Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, 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, 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.
Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
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Daniel Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
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Media Contact:
Ellie Hanson
FINN Partners for MediWound
ellie.hanson@finnpartners.com
+1-929-588-2008