<SEC-DOCUMENT>0001178913-23-002405.txt : 20230710
<SEC-HEADER>0001178913-23-002405.hdr.sgml : 20230710
<ACCEPTANCE-DATETIME>20230710073514
ACCESSION NUMBER:		0001178913-23-002405
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20230710
FILED AS OF DATE:		20230710
DATE AS OF CHANGE:		20230710

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			MediWound Ltd.
		CENTRAL INDEX KEY:			0001593984
		STANDARD INDUSTRIAL CLASSIFICATION:	MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-36349
		FILM NUMBER:		231078241

	BUSINESS ADDRESS:	
		STREET 1:		42 HAYARKON STREET
		CITY:			YAVNE
		STATE:			L3
		ZIP:			8122745
		BUSINESS PHONE:		97289324010

	MAIL ADDRESS:	
		STREET 1:		42 HAYARKON STREET
		CITY:			YAVNE
		STATE:			L3
		ZIP:			8122745
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>zk2329956.htm
<DESCRIPTION>6-K
<TEXT>
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    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;"> <br>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C.&#160; 20549<br>
      ______________________</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">FORM 6-K</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">REPORT&#160;OF FOREIGN PRIVATE ISSUER</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16 of the<br>
      Securities Exchange Act of 1934</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">For the month of July 2023</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Commission File Number: 001-36349</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25;"><font style="font-size: 14pt; font-family: 'Times New Roman',Times,serif;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</font><font style="font-weight: bold;"><u><font style="font-size: 16pt; font-family: 'Times New Roman',Times,serif;">MediWound Ltd.</font></u><font style="font-size: 16pt; font-family: 'Times New Roman',Times,serif;">&#160;</font></font><font style="font-size: 14pt; font-family: 'Times New Roman',Times,serif;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><br>
      (Translation of registrant&#8217;s name into English)</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">42 Hayarkon Street</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">Yavne, 8122745 Israel</div>
    <div style="text-align: center; line-height: 1.25;">&#160;(Address of principal executive offices)</div>
    <div style="text-align: center; line-height: 1.25;"> <br>
    </div>
    <div style="text-indent: 36pt; line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Form 20-F &#9746;&#160;&#160;&#160; Form 40-F &#9744;</div>
    <div style="line-height: 1.25; text-align: center; font-family: 'Times New Roman',Times,serif;">&#160;</div>
    <div style="text-indent: 36pt; line-height: 1.25;">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):&#160;&#160; __</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-indent: 36pt; line-height: 1.25;">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):&#160;&#160; __</div>
    <div style="text-indent: 36pt; line-height: 1.25;"> <br>
    </div>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">EXPLANATORY NOTE</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; text-indent: 36pt; line-height: 1.25;">On July 10, 2023, MediWound Ltd. (the &#8220;Company&#8221;) issued a press release entitled &#8220;MediWound Announces Positive Results in Its U.S. Phase I/II Study of MW005 for the Treatment of
      Basal Cell Carcinoma&#8221;. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; text-indent: 36pt; line-height: 1.25;">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&#8217;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 and August 9, 2022&#160;(Registration Nos. No. 333-195517, 333-210375,
      333-223767, 333-230487, 333-236635, 333-255784, and &#160;333-266697, 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).</div>
    <div style="text-align: justify; text-indent: 36pt; line-height: 1.25;"> <br>
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      <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="color: #000000; font-weight: normal; font-style: normal;">2</font></div>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURE</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-indent: 36pt; line-height: 1.25;">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.</div>
    <div><br>
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            <td valign="top" style="width: 50%;">&#160;</td>
            <td valign="top" colspan="2">MEDIWOUND LTD.</td>
            <td valign="top" style="width: 11%;">&#160;</td>
          </tr>
          <tr>
            <td valign="top" style="width: 50%;">&#160;</td>
            <td valign="top" style="width: 4%;">&#160;</td>
            <td valign="top" style="width: 35%;">&#160;</td>
            <td valign="top" style="width: 11%;">&#160;</td>
          </tr>
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            <td valign="top" align="left" style="width: 50%;">
              <div align="left" style="margin-left: 0pt; text-indent: 0pt; margin-right: 0pt">Date: July 10, 2023</div>
            </td>
            <td valign="top" style="width: 4%;">
              <div align="left" style="margin-left: 0pt; text-indent: 0pt; margin-right: 0pt">By: </div>
            </td>
            <td valign="top" nowrap="nowrap" align="left" style="width: 35%;"><u>/s/ Hani Luxenburg</u></td>
            <td valign="top" style="width: 11%;">&#160;</td>
          </tr>
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            <td valign="top" style="width: 50%;">&#160;</td>
            <td valign="top" style="width: 4%;">Name:</td>
            <td valign="bottom" nowrap="nowrap" align="left" style="width: 35%;">Hani Luxenburg</td>
            <td valign="top" style="width: 11%;">&#160;</td>
          </tr>
          <tr>
            <td valign="top" style="width: 50%;">&#160;</td>
            <td valign="top" style="width: 4%;">Title:</td>
            <td valign="top" style="width: 35%;">Chief Financial Officer</td>
            <td valign="top" style="width: 11%;">&#160;</td>
          </tr>

      </table>
    </div>
    <br>
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      <div class="BRPFPageNumberArea" style="text-align: center;"><font class="BRPFPageNumber" style="color: #000000; font-weight: normal; font-style: normal;">3</font></div>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">EXHIBIT INDEX</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="line-height: 1.25;">The following exhibit is filed as part of this Form 6-K:</div>
    <div style="line-height: 1.25;">&#160; &#160; &#160; <br>
    </div>
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            <td style="width: 72pt; vertical-align: top;"><u>Exhibit</u> <br>
            </td>
            <td style="width: auto; vertical-align: top; text-align: justify;">
              <div><u>Description</u></div>
            </td>
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        <tr>
          <td style="width: 72pt; vertical-align: top;"><a href="exhibit_99-1.htm">99.1</a></td>
          <td style="width: auto; vertical-align: top; text-align: justify;">
            <div><a href="exhibit_99-1.htm">Press release dated July 10, 2023 titled &#8220;MediWound Announces Positive Results in Its U.S. Phase I/II Study of MW005 for the
                Treatment of Basal Cell Carcinoma&#8221;.</a></div>
          </td>
        </tr>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <div style="line-height: 1.25; font-size: 12pt;">
      <div style="line-height: 1.25; text-align: right;"><font style="font-size: 10pt;"><u><font style="font-weight: bold;"> Exhibit 99.1</font></u></font><br>
      </div>
      <div style="line-height: 1.25;"><img src="image00001.jpg"></div>
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    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">MediWound Announces Positive Results in Its U.S. Phase I/II Study of MW005</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">for the Treatment of Basal Cell Carcinoma</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: center; line-height: 1.25;"><font style="font-style: italic;">MW005</font><font style="font-weight: bold;">&#160;</font><font style="font-style: italic;">shown to be safe and well-tolerated</font></div>
      <div style="line-height: 1.25">&#160;</div>
      <div style="text-align: center; line-height: 1.25; font-style: italic;">Data provide clinical efficacy proof-of-concept based on clearance of target lesions</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><font style="font-weight: bold;">YAVNE, Israel, July
          10, 2023</font> -- 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.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">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&#8217;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.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">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;&#160; 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.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">These results corroborate the previous proof-of-concept study published by Prof. Rosenberg et al (<font style="font-style: italic;">Basal Cell Carcinoma Destruction by a Concentrate of Proteolytic Enzymes Enriched in Bromelain: A Preliminary Report; TODJ-15-39, 2021</font>), where seven BCC tumors treated
        with MW005 were completely removed based on clinical assessment, and none reoccurred over the subsequent 24 months.</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#8220;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,&#8221; 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. &#8220;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.&#8221;</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Ofer Gonen, CEO of MediWound said, "These data further validate the potential of MW005 as a significant advancement in cancer
        treatment.&#160; 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."</div>
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;"> <br>
      </div>
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      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">About MediWound Ltd.</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25;"><font style="font-family: 'Times New Roman',Times,serif;">MediWound Ltd.&#160;(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.</font></div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">MediWound&#8217;s first drug, NexoBrid<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>, 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&amp;D pipeline including the Company&#8217;s lead drug under
      development, EscharEx<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>. 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&#8217;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.</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">For more information visit <u>www.mediwound.com</u>
      and follow the Company on <u>LinkedIn</u>.</div>
    <div style="line-height: 1.25;">
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-weight: bold;">Cautionary Note Regarding Forward-Looking Statements</div>
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">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 &#8220;anticipates,&#8221; &#8220;intends,&#8221; &#8220;estimates,&#8221;
        &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;continues,&#8221; &#8220;believe,&#8221; &#8220;guidance,&#8221; &#8220;outlook,&#8221; &#8220;target,&#8221; &#8220;future,&#8221; &#8220;potential,&#8221; &#8220;goals&#8221; and similar words or phrases, or future or conditional verbs such as &#8220;will,&#8221; &#8220;would,&#8221; &#8220;should,&#8221; &#8220;could,&#8221; &#8220;may,&#8221; or similar expressions.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">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.</div>
      <div style="line-height: 1.25; text-align: justify;">&#160;</div>
    </div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25;">These and other significant factors are discussed in greater detail in MediWound&#8217;s annual report on Form 20-F for the year ended
        December 31, 2022, filed with the Securities and Exchange Commission (&#8220;SEC&#8221;) 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&#8217;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.</div>
      <div style="text-align: justify; line-height: 1.25;"> <br>
      </div>
      <div style="text-align: justify; line-height: 1.25;">
        <div style="color: rgb(0, 0, 0); font-size: 13.3333px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: left; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; line-height: 1.25; font-weight: bold;">Contacts:</div>
        <div style="color: rgb(0, 0, 0); font-size: 13.3333px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; line-height: 1.25;"><br style="line-height: 1.25;">
        </div>
        <div style="color: rgb(0, 0, 0); font-size: 13.3333px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; line-height: 1.25;">
          <table cellspacing="0" cellpadding="0" border="0" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; color: rgb(0, 0, 0); width: 1887px;" id="z278ccdb905104eb4be8a40c8c7bb6b97">

              <tr>
                <td style="width: 566.094px;">
                  <div>
                    <div style="text-align: left; line-height: 1.25;">Hani Luxenburg<br>
                      </div>
                    <div style="text-align: left; line-height: 1.25;">Chief Financial Officer<br>
                      </div>
                    <div style="text-align: left; line-height: 1.25;">MediWound, Ltd.<br>
                      </div>
                    <div style="text-align: left; line-height: 1.25;"><font style="color: rgb(0, 0, 255);"><u>ir@mediwound.com</u></font><br>
                      </div>
                  </div>
                </td>
                <td style="width: 1320.91px;">
                  <div>Monique Kosse</div>
                  <div>Managing Director, LifeSci Advisors<br>
                    212-915-3820<br>
                    <font style="color: rgb(0, 0, 255);"><u>monique@lifesciadvisors.com</u></font></div>
                </td>
              </tr>

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      </div>
    </div>
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