<SEC-DOCUMENT>0001157523-22-000526.txt : 20220502
<SEC-HEADER>0001157523-22-000526.hdr.sgml : 20220502
<ACCEPTANCE-DATETIME>20220502161607
ACCESSION NUMBER:		0001157523-22-000526
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20220502
FILED AS OF DATE:		20220502
DATE AS OF CHANGE:		20220502

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Nanobiotix S.A.
		CENTRAL INDEX KEY:			0001760854
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			I0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39777
		FILM NUMBER:		22882159

	BUSINESS ADDRESS:	
		STREET 1:		60 RUE DE WATTIGNIES
		CITY:			PARIS
		STATE:			I0
		ZIP:			75012
		BUSINESS PHONE:		33140260470

	MAIL ADDRESS:	
		STREET 1:		60 RUE DE WATTIGNIES
		CITY:			PARIS
		STATE:			I0
		ZIP:			75012
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a52704637.htm
<DESCRIPTION>NANOBIOTIX S.A. 6-K
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    <div style="text-align: center; font-weight: bold; font-size: 16pt;">UNITED STATES</div>
    <font style="font-size: 16pt;"> </font>
    <div style="text-align: center; font-weight: bold; font-size: 16pt;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; font-weight: bold;">Washington, D.C. 20549</div>
    <div>&#160;</div>
    <div style="text-align: center; font-weight: bold; font-size: 16pt;">FORM 6-K</div>
    <div>&#160;</div>
    <div style="text-align: center; font-weight: bold;">Report of Foreign Private Issuer</div>
    <div style="text-align: center; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
    <div style="text-align: center; font-weight: bold;">of the Securities Exchange Act of 1934</div>
    <div>&#160;</div>
    <div style="text-align: center; font-weight: bold;">Date of Report: 05/02/2022</div>
    <div>&#160;</div>
    <div style="text-align: center; font-weight: bold;">Commission File Number: 001-39777</div>
    <div>&#160;</div>
    <div style="text-align: center; font-weight: bold; font-size: 20pt;">Nanobiotix S.A.</div>
    <div style="text-align: center; font-weight: bold;">(Exact Name of Registrant as Specified in its Charter)</div>
    <div>&#160;</div>
    <div style="text-align: center; font-weight: bold;">60 Rue de Wattignies</div>
    <div style="text-align: center; font-weight: bold;">75012 Paris, France</div>
    <div style="text-align: center; font-weight: bold;">(Address of principal executive office)</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 style="text-align: center;">Form 20-F <font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9746;</font> Form 40-F <font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></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): <font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></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): <font style="font-family: 'Segoe UI Symbol', sans-serif;">&#9744;</font></div>
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    <div style="font-weight: bold;"><u>EXHIBIT INDEX</u></div>
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            <div style="font-weight: bold;">Exhibit</div>
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            <div style="font-weight: bold;">Title</div>
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            <div><a href="a52704637ex99_1.htm">99.1</a></div>
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          <td style="width: 92%; vertical-align: top;">
            <div><a href="a52704637ex99_1.htm">Press Release, dated May 02, 2022</a></div>
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    <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>
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            <div style="font-weight: bold;">PORTER NOVELLI</div>
            <div>(Agency)</div>
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          <td style="width: 15%; vertical-align: top;">&#160;</td>
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            <div style="font-weight: bold;">NANOBIOTIX S.A.</div>
            <div>(Registrant)</div>
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            <div>By: <u>/s/ Emily Papp</u><br>
            </div>
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            <div>By:</div>
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            <div>
              <div><u>/s/ Bart Van Rhijn</u></div>
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          <td style="width: 36%; vertical-align: bottom;">
            <div><br>
              Emily Papp</div>
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          <td style="width: 15%; vertical-align: top;">&#160;</td>
          <td style="width: 2%; vertical-align: top;">&#160;</td>
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            <div><br>
              Bart Van Rhijn</div>
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          <td style="width: 3.63%; vertical-align: top;">&#160;</td>
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            <div>Account Supervisor</div>
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          <td style="width: 15%; vertical-align: top;">&#160;</td>
          <td style="width: 2%; vertical-align: top;">&#160;</td>
          <td style="width: 43%; vertical-align: top;">
            <div>Chief Financial Officer</div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a52704637ex99_1.htm
<DESCRIPTION>EXHIBIT 99.1
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  <div style="text-align: right;"><font style="font-weight: bold;">Exhibit 99.1</font><br>
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      <h1 style="text-align: center; list-style-position: inside;FONT-SIZE: 14pt;"> <b>New Data Featuring NANOBIOTIX Lead Product Candidate NBTXR3 to Be Presented at the 2022 ASCO Annual Meeting</b> </h1>
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          <p>PARIS &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 2, 2022--Regulatory News: </p>
          <p> NANOBIOTIX (Euronext: NANO &#8211; NASDAQ: NBTX &#8211; the &#8220;<b>Company</b>&#8221;), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the presentation of
            three abstracts featuring potential first-in-class radioenhancer NBTXR3 at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7. </p>
          <p> &#8220;We are aiming to significantly improve outcomes for patients with cancer through NBTXR3, and to do so we must validate the safety and efficacy of our innovation across solid tumor indications and in combination with existing treatment
            modalities,&#8221; said Laurent Levy, co-founder and chief executive officer of Nanobiotix. &#8220;Taken together with data we have previously reported on NBTXR3 as a single agent and in combination with checkpoint inhibitors, we expect the findings that
            will be presented at ASCO this year to add a new dimension to the story of NBTXR3 as we observe the radioenhancer&#8217;s performance in combination with chemotherapy. We will also highlight the design of our ongoing pivotal phase III study
            evaluating NBTXR3 as a single agent for frail, elderly patients with head and neck cancer.&#8221; </p>
          <p> The accepted abstracts include: </p>
          <ul style="list-style-type: disc;">
            <li> Abstract #18041: PEP503 (NBTXR3), a Radioenhancer, in Combination with Concurrent Chemoradiation (CCRT) in Locally Advanced or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC): Dose-Finding of a Phase 1b/2 Trial </li>
            <li> Abstract #3603: A Phase 1b/2 Study of Radioenhancer, PEP503 (NBTXR3), in Combination with Concurrent Chemoradiation in Locally Advanced or Unresectable Rectal Cancer </li>
            <li> Abstract #TPS6110:<b> </b>A Phase III Pivotal Study of NBTXR3 Activated by Investigator&#8217;s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Patients with Locally
              Advanced Head &amp; Neck Squamous Cell Carcinoma </li>
          </ul>
          <p> <b>About NBTXR3 <br>
            </b>NBTXR3 is a novel, potentially first-in-class oncology product, composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate&#8217;s
            physics-based mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering an adaptive immune response and long-term anti-cancer memory. Given the
            MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly, with immune checkpoint inhibitors. </p>
          <p> NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored phase I dose escalation and dose expansion study has produced favorable safety data and
            early signs of efficacy. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of
            patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy. </p>
          <p> Nanobiotix has also prioritized an Immuno-Oncology development program&#8212;beginning with a Company sponsored phase I clinical study, evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients
            with locoregional recurrent or recurrent/metastatic HNSCC and for patients with lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy, either na&#239;ve or resistant to prior PD-1 (either primary or secondary as per SITC
            criteria). </p>
          <p> Given the Company&#8217;s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in strategic collaborations to expand development of the product candidate in parallel with its priority development pathways.
            Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across
            tumor types and therapeutic combinations. In 2021, the Company entered into an additional strategic collaboration agreement with LianBio to support its global phase III study in Asia along with four future registrational studies. </p>
          <div> </div>
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          <p> <b>About NANOBIOTIX <br>
            </b>Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for
            humanity. The company&#8217;s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. </p>
          <p> Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, Germany and Switzerland. </p>
          <p> Nanobiotix has been listed on the regulated market of Euronext in Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. </p>
          <p> Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. The
            company's resources are primarily devoted to the development of its lead product candidate&#8211;NBTXR3&#8211;which is the product of its proprietary oncology platform and has already achieved market authorization in Europe for the treatment of patients
            with soft tissue sarcoma under the brand name Hensify<sup style="vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup>. </p>
          <p> For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter. </p>
          <p> <b>Disclaimer <br>
            </b><i>This press release contains certain &#8220;forward-looking&#8221; statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such
              as &#8220;at this time,&#8221; &#8220;anticipate,&#8221; &#8220;believe,&#8221; &#8220;expect,&#8221; &#8220;intend,&#8221; &#8220;on track,&#8221; &#8220;plan,&#8221; &#8220;scheduled,&#8221; and &#8220;will,&#8221; or the negative of these and similar expressions. These forward-looking statements, which are based on our management&#8217;s current
              expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our presentation of data, the results of our preclinical and clinical
              studies and their potential implications. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking
              statements are subject to numerous risks and uncertainties, including with respect to the risk that subsequent studies and ongoing or future clinical trials may not generate favorable data notwithstanding positive early clinical results and
              the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described
              in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the SEC) on April 8, 2022 under &#8220;Item 3.D. Risk Factors&#8221; and those set forth in the universal registration document of Nanobiotix filed with the French
              Financial Markets Authority (Autorit&#233; des March&#233;s Financiers &#8211; the AMF) on April 8, 2022, each as updated in our Half-Year Financial Report filed with the AMF and the SEC on September 8, 2021 (a copy of which is available on
              www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or
              implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in
              the forward-looking statements, even if new information becomes available in the future.</i> </p>
        </div>
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          <h2 style="FONT-SIZE: 14pt;">Contacts</h2>
          <p> <i>Nanobiotix </i><br>
            <b>Communications Department </b><br>
            <i>Brandon Owens </i><br>
            <i>VP, Communications </i><br>
            +1 (617) 852-4835 <br>
            contact@nanobiotix.com </p>
          <p> <b>Investor Relations Department </b><br>
            <i>Kate McNeil </i><br>
            <i>SVP, Investor Relations </i><br>
            +1 (609) 678-7388 <br>
            investors@nanobiotix.com </p>
          <p> <i>Media Relations </i><br>
            FR &#8211; <b>Ulysse Communication </b><br>
            Pierre-Louis Germain <br>
            +33 (0) 6 64 79 97 51 <br>
            plgermain@ulysse-communication.com </p>
          <p> US &#8211; <b>Porter Novelli </b><br>
            Caitlin Hunt <br>
            +1 (781) 985-5967 <br>
            Caitlin.hunt@porternovelli.com </p>
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