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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934
Securities Exchange Act of 1934
For the month of March 2020
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 March 30, 2020, Mediwound Ltd. (the “Company”) issued a press release providing an update on the Company’s
business due to the heightened uncertainty related to the COVID-19 pandemic. A copy of the press release is attached as Exhibit 99.1 to this report.
In addition, in light of the heightened uncertainty related to the COVID-19 pandemic, the Company is updating the
risk factors disclosed in Item 3.D. of its Form 20-F for the fiscal year ended December 31, 2019. Accordingly, the Company’s risk factor disclosure is updated to include the following additional risk factor:
The coronavirus (COVID-19) outbreak
could adversely impact our business, financial condition and results of operations.
In March 2020, the World Health Organization declared the ongoing coronavirus
(COVID-19) outbreak to be a pandemic. The coronavirus has spread throughout Israel where our headquarters and plant are located and in other areas where we have business operations. The spread of COVID-19 could have a negative impact on the value of
the Company and on the ability of the Company to raise capital (privately or publicly), conduct strategic deals, and continue to conduct clinical trials in medical centers, and could cause us to suspend the recruitment of patients in studies that
remain open. In addition it could negatively affect our manufacturing operations and global supply chain. In response to the outbreak, we have taken various measures to date, including executing a global remote work policy, suspension of all work
related travel, including for our field-based employees, suspension of all in-person meetings and interactions with the healthcare community until further notice, leveraging virtual tools and digital communication technologies to continue important
interactions with our employees, healthcare professionals, patients and other stakeholders, conducting remote site monitoring, transportation reimbursement and arranging additional shipments of investigational product to sites and we have instituted
alternating shifts and additional practices to help ensure the health and safety of our employees who work on critical tasks in our labs and manufacturing facility, as they continue to advance our science and deliver medicines for patients. In
addition, COVID-19 has had an adverse impact on and may continue to adversely impact the expected timelines of our clinical studies and contribute to delays in obtaining regulatory approvals and in receiving governmental funding. For example, we have
decided to temporarily suspend initiation of new clinical sites and patient enrollment in our U.S. Phase 2 adaptive design clinical study of EscharEx for the treatment of venous leg ulcers. These existing measures have disrupted, and any future
actions may result in further disruption, to our business, and may negatively impact our results of operations and financial position.
Our customers may also be adversely impacted by the prolonged impacts of the
COVID-19 pandemic. As a result of the deterioration in economic conditions, our customers and potential customers may elect to decrease their spending or reconsider orders, which would adversely affect our business, operating results and financial
condition. For example, in light of the significant impact of the COVID-19 pandemic in the U.S. and related expenditures by the U.S. federal government, we may
experience delays in deliveries of the procurement orders under our September 2015 agreement with the U.S. Biomedical Advanced Research and Development Authority (“BARDA”) and such agreement, as well as our other agreements with BARDA, may be
suspended or terminated by BARDA. BARDA may terminate the agreements at any time, at its convenience and without any further funding obligations. In addition, there may be limitations of product transportation that can impact our sales to customers.
Our suppliers, including Challenge Bioproducts Corporation Ltd. (“CBC”), may
be adversely impacted by the COVID-19 pandemic. As a result, we may face delays or difficulty sourcing components and drug substances for our products and product candidates, which could negatively affect our business and financial results. Even if
we are able to find alternate sources for such components and drug substances, they may cost more, which could adversely impact our profitability and financial condition.
As the magnitude of the impact on global markets from COVID-19 is difficult to
predict, the extent to which the pandemic may negatively affect our clinical and operational activities, operating results and financial condition is uncertain.
EXHIBIT INDEX
The following exhibits are furnished as part of this Form 6-K:
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Exhibit
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Description
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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.
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Date: March 30, 2020
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By:
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/s/ Boaz Gur-Lavie
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Name: Boaz Gur-Lavie
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Title: Chief Financial Officer
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Exhibit 99.1
MediWound Provides Corporate Update Related to COVID-19 Pandemic
YAVNE, Israel, March 30, 2020 -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company bringing innovative therapies to
address unmet needs in severe burn and wound management, today provided an update on certain impacts of the COVID-19 pandemic on its business operations and clinical programs.
In response to the evolving situation related to the spread of COVID-19, MediWound’s priority continues to be protecting the health of its employees and the communities in which they live and work.
At the same time, the Company is working to ensure that healthcare providers and patients have uninterrupted access to our commercial and products under development. With this in mind, MediWound has adopted a series of precautionary measures to
mitigate the potential spread of COVID-19, while also permitting the continuation of critical business functions. The Company has instituted a global remote work policy and is now leveraging virtual tools and digital communication technologies to
continue important interactions with its employees, healthcare professionals, patients and other stakeholders.
In light of the COVID-19 substantial impact on the global healthcare delivery system, and taking into account regulatory, institutional, and government guidance and policies, the Company has
decided to temporarily suspend the initiation of additional clinical sites and new patient enrollment in our U.S. EscharEx phase 2 study for the treatment of venous leg ulcers (“VLUs”). Existing EscharEx clinical sites are continuing to manage
randomized patients currently on treatment, including with the adoption of enhanced safety measures, such as the implementation of remote site monitoring, virtual tools and digital communication. Importantly, the Company is prepared and committed
to resume site expansion, patient screening and randomization once the situation permits.
The NexoBrid expanded access (“NEXT”) program continues to enroll patients, thus enabling U.S. burn centers to treat burn patients with NexoBrid. In addition, patient follow-up in the pivotal U.S.
Phase 3 clinical study (“DETECT”) of NexoBrid remains ongoing and the preparation of the Biologics License Application for NexoBrid continues as planned.
Currently, the Company’s manufacturing facility is operational, and there is sufficient inventory of NexoBrid on hand to meet expected demand over the next several quarters. However, the Company
continues to assess the potential impact of COVID-19 on its manufacturing operations and global supply chain, including potential adjustments to the U.S. Biomedical Advanced Research and Development Authority’s (“BARDA”) delivery plan of NexoBrid
emergency stock. At this time, the Company does not anticipate a change to its 2020 cash use guidance as a result of COVID-19.
“As a result of the COVID-19 pandemic and subsequent shelter-in-place orders that are occurring globally, we have made the decision to temporarily suspend patient enrollment in our EscharEx phase 2
study, said Sharon Malka, CEO of MediWound. “Our priorities now are the safety of the patients and healthcare providers who are participating in our clinical trials, the health and safety of our employees and external partners conducting our
trials, as well as reducing stress on the healthcare system.”
“In view of the challenges of the healthcare system, national burn care associations, including the Italian Society of Burn Surgery, have stressed the need to shift more burn patients toward
non-surgical care in order to alleviate the burden on acute care staff and inpatient operating rooms. This is consistent with clinical guidelines issued by national healthcare systems, such as the United Kingdom’s National Health Service, for the
management of acute burns during the COVID-19 pandemic, underscoring the role of enzymatic debridement for burn care in emergencies.”
Mr. Malka concluded, “Given the dynamic nature of the COVID-19 pandemic, we will continue to monitor its operations and will assess the need for further actions as appropriate. Supported by our
strong balance sheet, I firmly believe we can weather this storm. Our thoughts and prayers are with patients and families globally as we all face this pandemic together.”
About MediWound Ltd.
MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address
unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received
marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound’s second innovative product, EscharEx® is a topical biological drug
candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other
hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended,
and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding the impact of the COVID-19 pandemic on the Company’s
operations, including its ongoing clinical studies, enrollment of patients for the Company’s clinical studies, the timing of the Company’s clinical studies, the operation of the manufacturing facility, including the level of inventory, the filing
of the BLA and the Company’s expected financial results, including its cash use guidance. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,”
“plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events
and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. In particular, you should consider
the ongoing risks to our business and operations related to the COVID-19 outbreak; and the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2019 as well as information contained in
other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein
speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
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Contacts:
Boaz Gur-Lavie
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com
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Jeremy Feffer
Jeremy Feffer
Managing Director, LifeSci Advisors
212-915-2568
jeremy@lifesciadvisors.com
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