<SEC-DOCUMENT>0001140361-20-007597.txt : 20200401
<SEC-HEADER>0001140361-20-007597.hdr.sgml : 20200401
<ACCEPTANCE-DATETIME>20200331212940
ACCESSION NUMBER:		0001140361-20-007597
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20200331
FILED AS OF DATE:		20200401
DATE AS OF CHANGE:		20200331

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			InflaRx N.V.
		CENTRAL INDEX KEY:			0001708688
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			P7
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-38283
		FILM NUMBER:		20763540

	BUSINESS ADDRESS:	
		STREET 1:		WINZERLAER STR. 2
		CITY:			JENA
		STATE:			2M
		ZIP:			07745
		BUSINESS PHONE:		49 3641 508180

	MAIL ADDRESS:	
		STREET 1:		WINZERLAER STR. 2
		CITY:			JENA
		STATE:			2M
		ZIP:			07745

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Fireman B.V.
		DATE OF NAME CHANGE:	20170606
</SEC-HEADER>
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<TEXT>
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    <div>
      <div style="text-align: center; font-size: 14pt; font-weight: bold;">UNITED STATES</div>
      <div style="text-align: center; font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
      <div style="text-align: center; font-size: 12pt; font-weight: bold;">Washington, D.C. 20549</div>
      <div style="text-align: center;"><u>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </u></div>
      <div style="text-align: center; font-weight: bold;"> <br>
      </div>
      <div style="text-align: center; font-size: 18pt; font-weight: bold;">FORM 6-K</div>
      <div style="text-align: center;"><u>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </u></div>
      <div style="text-align: center; font-weight: bold;"> <br>
      </div>
      <div style="text-align: center; font-weight: bold;">REPORT OF FOREIGN PRIVATE ISSUER<br>
        PURSUANT TO RULE 13A-16 OR 15D-16 UNDER<br>
        THE SECURITIES EXCHANGE ACT OF 1934</div>
      <div>&#160;</div>
      <div style="text-align: center; font-weight: bold;">For the month of March, 2020</div>
      <div>&#160;</div>
      <div style="text-align: center; font-weight: bold;">Commission File Number: 001-38283</div>
      <div style="text-align: center;">&#160;<u>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </u></div>
      <div style="text-align: center; font-weight: bold;"> <br>
      </div>
      <div style="text-align: center; font-size: 24pt; font-weight: bold;">InflaRx N.V.</div>
      <div style="text-align: center; color: #000000;">(Translation of registrant's name into English)</div>
      <div style="text-align: center;"><u>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </u></div>
      <div style="text-align: center;"><font style="font-weight: bold;"> <br>
        </font></div>
      <div style="text-align: center;"><font style="font-weight: bold;">Winzerlaer Str. 2</font><br>
        <font style="font-weight: bold;">07745 Jena, Germany</font><br>
        (Address of principal executive office)</div>
      <div style="text-align: center;"><u>&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </u></div>
      <div>&#160;</div>
      <div>Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.</div>
      <div>&#160;</div>
      <div>Form 20-F &#9746; &#160;&#160;&#160;&#160;&#160;&#160;&#160; Form 40-F &#9744;</div>
      <div>&#160;</div>
      <div>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): &#9744;</div>
      <div>&#160;</div>
      <div>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): &#9744;</div>
      <div> <br>
      </div>
      <div>
        <hr align="center" style="border: none; border-bottom: 4px solid black; border-top: 1px solid black; height: 10px; color: #ffffff; background-color: #ffffff; text-align: center; margin-left: auto; margin-right: auto;"></div>
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      <div>
        <div style="text-align: center; font-weight: bold;">INFLARX N.V.</div>
        <div>&#160;</div>
        <div style="text-align: justify;">On March 31, 2020, InflaRx N.V. issued a press release titled &#8220;InflaRx Doses First Patient in Multicenter Randomized Clinical Trial in Severe Progressed COVID-19 Pneumonia in Europe upon Receipt of Initial Positive
          Human Data with InflaRx&#8217;s anti-C5a Technology.&#8221;</div>
        <div>&#160;</div>
        <div style="text-align: justify;">A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.</div>
        <div>&#160;</div>
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      <div>
        <div style="text-align: center; font-weight: bold;">SIGNATURES</div>
        <div>&#160;</div>
        <div>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>&#160;</div>
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            <tr>
              <td style="width: 50%; vertical-align: top;">&#160;</td>
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                <div style="font-weight: bold;">INFLARX N.V.</div>
              </td>
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            <tr>
              <td style="width: 50%; vertical-align: top;" rowspan="1">&#160;</td>
              <td style="vertical-align: top;" colspan="2" rowspan="1">&#160;</td>
            </tr>
            <tr>
              <td style="width: 50%; vertical-align: top;">
                <div>Date: March 31, 2020</div>
              </td>
              <td style="width: 5%; vertical-align: top;">
                <div>By:</div>
              </td>
              <td style="width: 45%; vertical-align: top; border-bottom: 2px solid black;">
                <div>/s/ Niels Riedemann</div>
              </td>
            </tr>
            <tr>
              <td style="width: 50%; vertical-align: top;">&#160;</td>
              <td style="width: 5%; vertical-align: top;">
                <div>Name:</div>
              </td>
              <td style="width: 45%; vertical-align: top;">
                <div>Niels Riedemann</div>
              </td>
            </tr>
            <tr>
              <td style="width: 50%; vertical-align: top;">&#160;</td>
              <td style="width: 5%; vertical-align: top;">
                <div>Title:</div>
              </td>
              <td style="width: 45%; vertical-align: top;">
                <div>Chief Executive Officer</div>
              </td>
            </tr>

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        <div style="text-align: center; font-weight: bold;">EXHIBIT INDEX</div>
        <div>&#160;</div>
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                <div style="font-weight: bold;">Exhibit No.</div>
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              <td style="width: 87.5%; vertical-align: bottom; border-bottom: 2px solid rgb(0, 0, 0);">
                <div style="font-weight: bold;">Description</div>
              </td>
            </tr>
            <tr>
              <td style="width: 10.5%; vertical-align: top;">
                <div><a href="ex99_1.htm">99.1</a></div>
              </td>
              <td style="width: 2%; vertical-align: top;" colspan="1">&#160;</td>
              <td style="width: 87.5%; vertical-align: bottom;">
                <div>Press Release, dated March 31, 2020</div>
              </td>
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      <div> <br>
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      <div> <br>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex99_1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <div style="text-align: right;"><font style="font-weight: bold;">Exhibit 99.1</font><br>
    </div>
    <div style="text-align: right;"><font style="font-weight: bold;"> <br>
      </font></div>
    <div><img src="image00001.jpg">
      <div><br>
      </div>
      <div>
        <div style="text-align: center;">InflaRx Doses First Patient in Multicenter Randomized Clinical Trial in Severe Progressed COVID-19 Pneumonia in Europe upon Receipt of Initial Positive Human Data with InflaRx&#8217;s anti-C5a Technology</div>
        <div><br>
        </div>
        <div>
          <div>
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                  </td>
                  <td style="width: 18pt; vertical-align: top; align: right;"><font style="font-family: Times New Roman">&#8226;</font></td>
                  <td style="width: auto; vertical-align: top;">
                    <div>InflaRx has dosed the first patient in an adaptive randomized controlled clinical study with IFX-1 in patients with severe COVID-19 pneumonia in the Netherlands</div>
                  </td>
                </tr>

            </table>
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        <div>
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                  </td>
                  <td style="width: 18pt; vertical-align: top; align: right;"><font style="font-family: Times New Roman">&#8226;</font></td>
                  <td style="width: auto; vertical-align: top;">
                    <div>InflaRx received initial positive human data from its licensee, Beijing Defengrei Biotechnology Co. Ltd. (BDB), suggesting a potential role of C5a in COVID-19</div>
                  </td>
                </tr>

            </table>
          </div>
        </div>
        <div>&#160;</div>
        <div style="text-align: justify;"><font style="font-weight: bold;">Jena, Germany, March 31, 2020 </font>&#8211; InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement
          system, today announced the enrollment of the first patient into a randomized clinical trial investigating the safety and efficacy of IFX-1, the company&#180;s monoclonal anti-C5a antibody, in patients with severe COVID-19-induced pneumonia. The
          company has received initial positive human data from two initial patients suffering from COVID-19-induced severe pneumonia who were treated with BDB-001, an anti-C5a antibody produced by BDB from the IFX-1 cell line, in China. Data from the two
          patients are part of a larger investigation on the role of complement activation in COVID-19 which have been made publicly available through a pre-print server and have not been independently validated by InflaRx.</div>
        <div>&#160;</div>
        <div style="text-align: justify;">Based on the company&#180;s existing pre-clinical research on the role of C5a in viral-induced pneumonia and the initial results from the BDB study, InflaRx has decided to initiate a clinical development program with
          IFX-1 in COVID-19 patients with severely progressed pneumonia. The company has received regulatory approval to start the trial in the Netherlands and enrolled the first patient at the Amsterdam University Medical Centers. Subject to regulatory
          approval, the company plans to initiate additional centers in Germany and potentially other European countries.</div>
        <div>&#160;</div>
        <div style="text-align: justify;">With regard to InflaRx&#8217;s other ongoing clinical trials, the company is monitoring the impact of COVID-19 on its programs. The company&#8217;s current clinical trial sites remain active; however, it is possible that sites
          have paused or will pause screening of new patients, and there may be other delays or consequences as the pandemic evolves. Therefore, we cannot predict the future impact on the programs or the company as a whole at present.</div>
        <div>&#160;</div>
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        <div><img src="image00001.jpg"></div>
        <div>&#160;</div>
        <div style="text-align: justify; font-weight: bold;">About IFX-1:</div>
        <div style="text-align: justify;">IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human
          blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory
          response driven tissue and organ damage by specifically blocking C5a as a key &#8220;amplifier&#8221; of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately
          300 people have been treated with IFX-1 in clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various inflammatory indications, including Hidradenitis Suppurativa, ANCA-associated
          vasculitis and Pyoderma Gangraenosum.</div>
        <div>&#160;</div>
        <div style="text-align: justify; font-weight: bold;">About InflaRx N.V.:</div>
        <div style="text-align: justify;">InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement
          C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as
          Ann Arbor, MI, USA. For further information please visit <u>www.inflarx.com</u>.</div>
        <div>&#160;</div>
        <div style="text-align: justify;">On December 28, 2015, InflaRx entered into a co-development agreement with Beijing Defengrei Biotechnology Co. Ltd., or BDB, for the use of the IFX-1 technology and cell line in BDB&#8217;s development of drug candidates
          for sale in China. Pursuant to the agreement, InflaRx granted BDB an exclusive, non-transferable license to use the IFX-1 cell line and related intellectual property solely to develop and commercialize BDB&#8217;s drug candidates, including BDB-001, in
          China.&#160; Pursuant to the agreement, InflaRx is entitled to receive royalties on net sales of BDB&#8217;s products containing BDB-001 and reserves the right to commercialize products containing BDB-001 outside of China.</div>
        <div>&#160;</div>
        <div style="text-align: justify; font-weight: bold;">Contacts:</div>
        <div style="text-align: justify; font-weight: bold;">InflaRx N.V.</div>
        <div style="text-align: justify;">Jordan Zwick &#8211; Global Head of Business Development &amp; Corporate Strategy</div>
        <div style="text-align: justify;">Email: jordan.zwick[at]inflarx.de</div>
        <div style="text-align: justify;">Tel: +1 917-338-6523</div>
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        <div>&#160;</div>
        <div style="text-align: justify; font-weight: bold;">MC Services AG</div>
        <div style="text-align: justify;">Katja Arnold, Laurie Doyle, Andreas Jungfer</div>
        <div style="text-align: justify;">Email: inflarx[at]mc-services.eu</div>
        <div style="text-align: justify;">Europe: +49 89-210 2280</div>
        <div style="text-align: justify;">US: +1-339-832-0752</div>
        <div>&#160;</div>
        <div style="text-align: justify;">FORWARD-LOOKING STATEMENTS</div>
        <div>&#160;</div>
        <div style="text-align: justify;">This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as &#8220;may,&#8221; &#8220;will,&#8221; &#8220;should,&#8221;
          &#8220;expect,&#8221; &#8220;plan,&#8221; &#8220;anticipate,&#8221; &#8220;could,&#8221; &#8220;intend,&#8221; &#8220;target,&#8221; &#8220;project,&#8221; &#8220;estimate,&#8221; &#8220;believe,&#8221; &#8220;estimate,&#8221; &#8220;predict,&#8221; &#8220;potential&#8221; or &#8220;continue&#8221; and similar expressions. Forward-looking statements appear in a number of places throughout this
          release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, including with
          respect to IFX-1 for the treatment of patients with severe COVID-19 pneumonia, the impact of the COVID-19 pandemic on the company, the timing of and our ability to commence and conduct clinical trials, make regulatory filings and obtain and
          maintain regulatory approvals for our product candidates, our intellectual property position, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition,
          liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks uncertainties and other factors described under the heading &#8220;Risk Factors&#8221; in
          InflaRx&#8217;s periodic filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual
          results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place
          undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.</div>
        <div style="text-align: justify;"> <br>
        </div>
        <div style="text-align: justify;"> <br>
        </div>
        <div style="text-align: justify;">
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
