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 July 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 July 16, 2024, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Announces €16.25
Million Funding from the European Innovation Council Accelerator Program”. 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:
Exhibit 99.1
MediWound Announces €16.25 Million Funding from the European
Innovation Council Accelerator Program
Funds to be used for clinical development of EscharEx® to treat diabetic foot ulcers (DFUs)
Award advances MediWound’s DFU program and its future revenues four years ahead of original schedule
YAVNE, Israel, July 16, 2024 -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today it has been selected to receive €16.25
million in blended funding from the European Innovation Council (EIC) through its accelerator program. The funding will significantly advance the Company’s EscharEx development program for patients with diabetic foot ulcers (DFUs).
Pending FDA and EMA approval, the funding will enable the Company to expedite the market introduction of this innovative biologic by four years, well ahead of MediWound’s original schedule.
The EIC Accelerator offers grants and equity investments to support innovative, game-changing products. In addition to financial
support, selected projects benefit from a range of business acceleration services that provide access to global experts, businesses, investors and ecosystem players. The funding package includes a €2.5 million grant and an investment, with terms to
be finalized between the Company and the EIC.
“We are honored to be selected for this prestigious and highly competitive program,” stated Ofer Gonen, Chief Executive Officer
of MediWound. “The EIC’s support recognizes EscharEx’s potential to profoundly impact patients, especially those living with the significant challenges of DFUs. This funding will enable MediWound to develop EscharEx for DFU in parallel with our
advanced program for treating venous leg ulcers (VLUs), substantially increasing the overall market.”
With 70% of DFU patients requiring debridement, EscharEx addresses a staggering market of up to 34 million diabetic patients (US
and Europe) who are at risk of developing a DFU in their lifetime. If not properly treated, DFUs can lead to serious complications including amputations, infections and death. Accelerating this program will have a revolutionary impact on the future
DFU treatment for the millions of patients in this underserved population.
For more information about the EIC Accelerator, visit https://eic.ec.europa.eu/eic-funding-opportunities/eic-accelerator_en.
EscharEx® is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds,
currently in advanced stages of clinical development. It is a concentrate of proteolytic enzymes enriched with bromelain for topical, easy to use daily applications. In several Phase II trials, EscharEx was shown to be safe and well-tolerated. It
demonstrated efficacy in debridement, the promotion of granulation tissue, and the reduction of bioburden and biofilm in various hard-to-heal wounds, effectively preparing the wound bed for healing. MediWound is set to initiate a Phase III study for
Venous Leg Ulcers in the second half of 2024, and a Phase II/III study targeting Diabetic Foot Ulcers in the second half of 2025.
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 awarding of the EIC funding, the possibility to reach agreements regarding the investment, the EIC funding
expected amount, the anticipated progress, development, timelines, expectations and commercial potential of EscharEx®, including the DFU program. There can be no assurance that we will be able to receive the full award amount, reaching an agreement with the EIC, starting or completing the developed of EscharEx for DFU and/or the
EscharEx will be approved for DFU indication. Among the factors that may cause results to be materially different from those stated herein are the failure to reach grant agreement and/or investment agreement between the Company and the EIC,
market and other conditions, industry or political conditions in the Europe or internationally, 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 product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and
approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our
intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our
ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s
annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking
statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or
circumstances that occur after the date of this release except as required by law.
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