<SEC-DOCUMENT>0001157523-22-000737.txt : 20220607
<SEC-HEADER>0001157523-22-000737.hdr.sgml : 20220607
<ACCEPTANCE-DATETIME>20220607094016
ACCESSION NUMBER:		0001157523-22-000737
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20220605
FILED AS OF DATE:		20220607
DATE AS OF CHANGE:		20220607

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:		221000103

	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
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<FILENAME>a52739539.htm
<DESCRIPTION>NANOBIOTIX S.A. 6-K
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    <div>&#160;</div>
    <div style="text-align: center; font-family: 'Times New Roman',serif; font-size: 16pt; font-weight: bold;">UNITED STATES</div>
    <font style="font-size: 16pt;"> </font>
    <div style="text-align: center; font-family: 'Times New Roman',serif; font-size: 16pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
    <div style="text-align: center; font-family: 'Times New Roman', serif; font-size: 12pt; font-weight: bold;">Washington, D.C. 20549</div>
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    <div style="text-align: center; font-family: 'Times New Roman',serif; font-size: 16pt; font-weight: bold;">FORM 6-K</div>
    <div>&#160;</div>
    <div style="text-align: center; font-family: 'Times New Roman', serif; font-size: 12pt; font-weight: bold;">Report of Foreign Private Issuer</div>
    <div style="text-align: center; font-family: 'Times New Roman', serif; font-size: 12pt; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
    <div style="text-align: center; font-family: 'Times New Roman', serif; font-size: 12pt; font-weight: bold;">of the Securities Exchange Act of 1934</div>
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    <div style="text-align: center; font-family: 'Times New Roman', serif; font-weight: bold;">Date of Report: 06/05/2022</div>
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    <div style="text-align: center; font-family: 'Times New Roman', serif; font-weight: bold;">Commission File Number: 001-39777</div>
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    <div style="text-align: center; font-family: 'Times New Roman',serif; font-size: 16pt; font-weight: bold;">Nanobiotix S.A.</div>
    <div style="text-align: center; font-family: 'Times New Roman', serif; font-weight: bold;">(Exact Name of Registrant as Specified in its Charter)</div>
    <div>&#160;</div>
    <div style="text-align: center; font-family: 'Times New Roman', serif; font-weight: bold;">60 Rue de Wattignies</div>
    <div style="text-align: center; font-family: 'Times New Roman', serif; 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 style="font-family: 'Times New Roman', serif;">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; font-family: 'Times New Roman', serif;">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 style="font-family: 'Times New Roman', serif;">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 style="font-family: 'Times New Roman', serif;">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-family: 'Times New Roman', serif; font-weight: bold;"><u>EXHIBIT INDEX</u></div>
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            <div style="font-family: 'Times New Roman', serif;"><a href="a52739539ex99_1.htm">99.1</a></div>
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          <td style="width: 91%; vertical-align: top;">
            <div style="font-family: 'Times New Roman', serif;"><a href="a52739539ex99_1.htm">Press Release, dated June 05, 2022</a></div>
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    <div style="text-align: center; font-family: 'Times New Roman', serif; font-weight: bold;">SIGNATURES</div>
    <div>&#160;</div>
    <div style="font-family: 'Times New Roman', serif;">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-family: 'Times New Roman', serif;">(Agency)</div>
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            <div style="font-family: 'Times New Roman', serif; font-weight: bold;">NANOBIOTIX S.A.</div>
            <div style="font-family: 'Times New Roman', serif;">(Registrant)</div>
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            <div><font style="font-family: 'Times New Roman', serif;">By: <u>/s/ Emily Papp</u><br>
              </font></div>
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            <div style="font-family: 'Times New Roman', serif;">By:</div>
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            <div>
              <div style="font-family: 'Times New Roman', serif;">/s/ Bart Van Rhijn</div>
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            <div style="font-family: 'Times New Roman', serif;">Bart Van Rhijn</div>
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            <div style="font-family: 'Times New Roman', serif;">Chief Financial Officer</div>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>a52739539ex99_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>NANOBIOTIX: New Data Featuring NBTXR3 Plus Chemoradiation and in the Preoperative Setting Support Broad Applicability for Head and Neck Cancer and Other Solid Tumor
          Indications</b> </h1>
      <div class="bw-release-subhead">
        <p style="text-align: center; list-style-position: inside;"><b> <b><i>Data reported at the 2022 Annual Meeting of the American Society for Clinical Oncology</i></b> </b></p>
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          <b>
            <li> NBTXR3 is being developed as a product candidate with potential to integrate across the standards of care in oncology, and these data from collaborator-sponsored phase 1b/2 studies add support for the radioenhancer in combination with
              chemoradiation and in the preoperative setting </li>
            <li> Data from the phase 1b/2 head and neck cancer study in 12 evaluable patients with stage 4 disease showed that combining NBTXR3 with concurrent chemoradiation was feasible, had a favorable safety profile, produced a 100% disease control
              rate, and an overall response rate of 58.3% </li>
            <li> Data from the phase 1b/2 rectal cancer study in 31 evaluable patients with unresectable disease showed that combining NBTXR3 with concurrent chemoradiation in the preoperative setting was feasible, had a favorable safety profile, enabled
              96% of evaluable patients to undergo R0 surgery, produced a 100% disease-control rate, a 35.5% overall response rate, and a 20% pathological complete response rate in 25 patients who underwent surgery </li>
          </b>
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          <p>PARIS &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 5, 2022--Regulatory News: </p>
          <p> NANOBIOTIX (Euronext : NANO &#8211;&#8211; Nasdaq: NBTX &#8211; the &#8216;&#8216;<b>Company</b>&#8217;&#8217;), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the reporting
            of new data at the 2022 Annual Meeting of the American Society for Clinical Oncology (ASCO) featuring potential first-in-class radioenhancer NBTXR3 in combination with concurrent chemoradiation for the treatment of head and neck cancer and
            rectal cancer. Nanobiotix also presented a trial-in-progress poster on the study design of the Company's ongoing pivotal phase 3 study, NANORAY-312, evaluating NBTXR3 as a single agent activated by radiotherapy for the treatment of elderly and
            frail patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are ineligible for platinum-based chemotherapy (cisplatin). </p>
          <p> In view of the Company's strategy for development of NBTXR3 as a product candidate that can integrate across solid tumor indications along with major treatment modalities within each indication, starting with head and neck cancer, the company
            believes these new data add support for the radioenhancer in combination with chemoradiation and as a neoadjuvant (preoperative) therapy with the potential to improve surgical outcomes. "Revolutionizing treatment outcomes for millions of
            patients with cancer will require integration of NBTXR3 across solid tumor indications, treatment modalities, and lines of therapy where radiation is a part of the treatment regimen&#8212;starting with head and neck cancer," said Laurent Levy,
            co-founder and chairman of the executive board at Nanobiotix. "Taken together with the clinical data we have already produced for NBTXR3 as a single agent activated by radiotherapy and as a combination agent with anti-PD-1, we view the new
            chemoradiation data presented at ASCO as critical validation of NBTXR3's feasibility across the standard of care. As we continue to prioritize our ongoing pivotal phase 3 study for elderly and frail patients with locally advanced head and neck
            squamous cell carcinoma, our aim is to build a comprehensive approach to the treatment of patients with locally advanced head and neck cancer that will serve as a model for our radioenhancer in other indications." </p>
          <p> <b><u>A Comprehensive Approach to Locally Advanced Head and Neck Cancer Inclusive of Chemoradiation</u></b> </p>
          <p> Most cisplatin-eligible patients with LA-HNSCC receive multimodal therapy including high dose concurrent chemoradiation (CCRT) as the standard of care. While CCRT has shown to improve local control and extend survival, the toxicity of high
            dose cisplatin creates challenges. These challenges appear both in terms of compliance with the treatment regimen for patients undergoing therapy that can impair efficacy, and in terms of the patients' quality of life after treatment. Although
            changes to the treatment protocol have been explored in randomized studies to reduce toxicity and improve compliance, reduction in toxicity has also led to reduction in efficacy. </p>
          <p> These patients need innovative new therapeutic options that do not create additional burden in their administration, do not add combined toxicity to radiotherapy and chemotherapy, and have the potential to improve survival. </p>
          <p> <u>A Phase 1b/2 Study Evaluating NBTXR3 in Combination with Concurrent Chemoradiation for Patients with Locally Advanced or Recurrent Head and Neck Squamous Cell Carcinoma</u> </p>
          <p> This study, sponsored, executed, and reported by former Nanobiotix collaborator in Asia, PharmaEngine, Inc. (PEI), sought to evaluate the safety and feasibility of NBTXR3 intratumoral injection when added to low-dose weekly
            cisplatin-containing CCRT for patients with locally advanced or recurrent head and neck squamous cell carcinoma. The study also aimed to establish the recommended phase 2 dose (RP2D), however the RP2D was not determined due to stoppage of the
            phase 1b part of the trial resulting from the conclusion of the collaboration between PEI and Nanobiotix in 2021. </p>
          <p> Adult patients with T3-4 LA-HNSCC suitable for cisplatin were eligible for the study and 12 such patients were enrolled. These patients received a single intratumoral injection of NBTXR3, followed by a low-dose weekly regimen of CCRT. All 12
            patients were deemed evaluable and all had stage 4 locally advanced disease. </p>
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          <p> Of these evaluable patients, 3, 6, and 3 patients received NBTXR3 at the 5%, 10%, and 15% dose levels, respectively. No serious adverse events (SAEs) inconsistent with what would normally be expected from a low-dose CCRT regimen were
            observed. Dose-limiting toxicities of grade 3 increased ALT and grade 3 increased AST were observed in one patient at the 10% dose level. Common Grade 3 adverse events (AEs) observed across dose levels were stomatitis, decreased WBC, decreased
            appetite, decreased neutrophil count, and leukopenia. One patient experienced grade 4 hyponatremia. </p>
          <p> Preliminary efficacy results showed a disease control rate of 100%, with an overall response rate of 58.3% according to RECIST 1.1. The study concluded that adding a single intratumoral injection of NBTXR3 to weekly low dose
            cisplatin-containing CCRT was feasible and had a favorable safety profile for patients with LA-HNSCC. </p>
          <p> <b><u>Strengthening Support for NBTXR3 in Combination with Chemoradiation in the Preoperative Setting</u></b> </p>
          <p> Colorectal cancer (CRC) is the third most common cancer indication worldwide and the second leading cause of cancer-related death in the United States. One-third of CRCs appear in the rectum. For patients with locally advanced rectal cancer
            (LARC), combined modality therapy with neoadjuvant CCRT, followed by total mesorectal excision (TME; surgery), followed by adjuvant (post-operative) systemic chemotherapy is the current standard of care. The aim of the neoadjuvant portion of
            the treatment regimen is to control and downstage the disease to allow for R0 TME (surgical removal with a negative margin in which no gross or microscopic tumor remains in the primary tumor bed), as clinical studies have shown a positive
            correlation between improved cancer-specific survival and R0 TME. While outcomes have improved, patients are still faced with a highly toxic treatment regimen that can lead to a lack of compliance which may hamper efficacy, along with
            deteriorated quality of life after treatment. </p>
          <p> Innovation with the potential to improve the rate of R0 resection without adding toxicity is an urgent need for this patient population. </p>
          <p> <u>A Phase 1b/2 Study Evaluating NBTXR3 in Combination with Concurrent Chemoradiation in the Neoadjuvant Setting for Patients with Locally Advanced or Unresectable Rectal Cancer</u> </p>
          <p> This study, sponsored, executed, and presented by PEI, sought to evaluate safety, feasibility, and early signs of efficacy for neoadjuvant NBTXR3 combined with CCRT followed by surgery for patients with locally advanced or unresectable rectal
            cancer. The study established the recommended phase 2 dose of NBTXR3 at 22% of gross tumor volume, however the phase 2 part of the trial was stopped as a result of the conclusion of the collaboration between PEI and Nanobiotix in 2021. Adult
            and older patients with T3-T4 locally advanced or unresectable rectal cancer suitable for chemoradiation were eligible for the study and 32 such patients were enrolled. These patients received a single intratumoral injection of NBTXR3, followed
            by a weekly regimen of CCRT. 31 of 32 patients were deemed evaluable and none of the evaluable patients had tumors eligible for surgery at the time of diagnosis. </p>
          <p> Of the 31 evaluable patients, 6, 4, 3, and 18 patients received NBTXR3 at the 5%, 10%, 15%, and 22% dose levels, respectively. No NBTXR3-related SAEs or grade &#8805; 3 AEs were observed. The most frequently reported AEs were grade 1 or 2 decreased
            WBC, diarrhea, increased CRP, UTI, and decreased lymphocyte count which were all consistent with what would normally be expected from CCRT. </p>
          <p> Preliminary efficacy results showed a disease control rate of 100%, with an overall response rate of 35.5% according to RECIST 1.1. Pathological tumor downstaging was observed in 14 of 31 patients after therapy, 25 patients underwent surgery,
            and 96% of those patients achieved R0 surgical margins. Pathological complete response was observed in 20% of the patients who received surgery. The study concluded that a single intratumoral injection of NBTXR3 in combination with CCRT is
            feasible and has a favorable safety profile in the neoadjuvant setting for patients with locally advanced or unresectable rectal adenocarcinoma. </p>
          <p style="text-align: center; list-style-position: inside;"> <b>***</b> </p>
          <p> <b>About NBTXR3</b> </p>
          <p> NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate&#8217;s physical mechanism
            of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix
            believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. </p>
          <div> </div>
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          </div>
          <p> <b>About NANOBIOTIX</b> </p>
          <p> 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 is leveraging its proprietary nanoparticle platform, including its lead product candidate, radiotherapy activated NBTXR3, to develop a pipeline of therapeutic options designed to enhance local and systemic control of solid
            tumors with an initial focus on the treatment of head and neck cancers. </p>
          <p> For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter. </p>
          <p> <b>Disclaimer</b> </p>
          <p> <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 </i><i>www.nanobiotix.com</i><i>),
              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>
        <div class="bw-release-contact">
          <h2 style="FONT-SIZE: 14pt;">Contacts</h2>
          <p> <i>Nanobiotix</i> </p>
          <p> <b><i>C</i>ommunications Department </b><br>
            <i>Brandon Owens </i><br>
            <i>VP, Communications </i><br>
            +1 (617) 852-4835 <br>
            contact@nanobiotix.com<u> </u> </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> </p>
          <p> 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>
            <u>Caitlin.hunt@porternovelli.com</u> </p>
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