1. In accordance with Articles L.233-8 II of the French Commercial Code and 223-16 of the General Regulations of the Autorité des Marchés Financiers (French Financial Markets Authority)

    Regulatory News:

    Nanobiotix (Paris:NANO) (NASDAQ:NBTX):

    Market: Euronext Paris
    Compartment: B
    ISIN code: FR0011341205
    Website: www.nanobiotix.com

    Date

    Number of Shares

    Outstanding

    Total number of voting rights

    Total voting rights,

    gross (1) 

    Total voting rights,

    net (2)

    August 31, 2021

    34,825,872

    36,019,979

    36,010,846

    (1) The total number of gross (or "theoretical") voting rights is used as the basis for calculating threshold crossings. In accordance with Article 223-11 of the AMF General Regulations, this number is calculated

    In accordance with Articles L.233-8 II of the French Commercial Code and 223-16 of the General Regulations of the Autorité des Marchés Financiers (French Financial Markets Authority)

    Regulatory News:

    Nanobiotix (Paris:NANO) (NASDAQ:NBTX):

    Market: Euronext Paris

    Compartment: B

    ISIN code: FR0011341205

    Website: www.nanobiotix.com

    Date

    Number of Shares

    Outstanding

    Total number of voting rights

    Total voting rights,

    gross (1) 

    Total voting rights,

    net (2)

    August 31, 2021

    34,825,872

    36,019,979

    36,010,846

    (1) The total number of gross (or "theoretical") voting rights is used as the basis for calculating threshold crossings. In accordance with Article 223-11 of the AMF General Regulations, this number is calculated on the basis of all shares to which voting rights are attached, including those for which voting rights have been suspended.

    (2) The total number of net (or "exercisable at a Shareholders' Meeting") voting rights is calculated without taking into account shares for which voting rights have been suspended. It is released in order to ensure that the public is properly informed, in accordance with the AMF recommendation of July 17, 2007.

    ***

    About NANOBIOTIX : http://www.nanobiotix.com

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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–NBTXR3—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®.

    For more information about Nanobiotix, visit us at http://www.nanobiotix.comor follow us on LinkedIn and Twitter.

    View Full Article Hide Full Article
    • Positive data from Study 102 Expansion reported in H1 2021 included an overall objective response rate of 82.5% and a complete response rate of 62.5% in highly vulnerable, elderly patient population, providing continued support for the planned initiation of a pivotal phase III global registration study in locally advanced head and neck squamous cell carcinoma in late Q4 2021
    • Following positive data from ongoing Study 1100 presented in H1 2021 showing that NBTXR3 in combination with anti-PD-1 resulted in tumor regression in 76.9% of evaluable patients regardless of prior anti-PD-1 exposure, Nanobiotix intends to initiate discussions with regulatory authorities in H2 2021 regarding the potential registration pathway for this immunotherapy combination…
    • Positive data from Study 102 Expansion reported in H1 2021 included an overall objective response rate of 82.5% and a complete response rate of 62.5% in highly vulnerable, elderly patient population, providing continued support for the planned initiation of a pivotal phase III global registration study in locally advanced head and neck squamous cell carcinoma in late Q4 2021
    • Following positive data from ongoing Study 1100 presented in H1 2021 showing that NBTXR3 in combination with anti-PD-1 resulted in tumor regression in 76.9% of evaluable patients regardless of prior anti-PD-1 exposure, Nanobiotix intends to initiate discussions with regulatory authorities in H2 2021 regarding the potential registration pathway for this immunotherapy combination
    • Reported €102.3 million in cash and cash equivalents as of June 30, 2021

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, provided an update on operational progress and announced its half year financial results for the six-month period ended June 30, 2021.

    First Half Operational Highlights, Pipeline Status and Upcoming Milestones

    Priority Pathway in Head & Neck Cancer, Local Control as Single Agent Activated by Radiotherapy: Leveraging proof-of-concept demonstrated in a successful Phase II/III study and subsequent EU marketing authorization for soft tissue sarcoma, Nanobiotix is currently evaluating NBTXR3 as a single agent activated by radiotherapy in other solid tumor indications with an initial focus on locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

    • Updated data from Study 102 Expansion, a phase I dose expansion study evaluating NBTXR3 as a single agent activated by radiotherapy in LA-HNSCC presented at the 2021 Annual Meeting of The American Society for Clinical Oncology (ASCO) continue to support NBTXR3 administration as feasible and well-tolerated in highly vulnerable elderly LA-HNSCC patients with high unmet medical needs and significant burden of disease. At a median follow up of 8.1 months, evaluable patients (n=40) demonstrated a high primary tumor ORR of 82.5% and a 62.5% CRR.1 These results are consistent with those observed in the dose escalation part of the study and suggest durability of effect.
    • Expect to report an analysis of progression free survival (PFS) and overall survival (OS) from 41 evaluable patients in Study 102 at a medical conference during the fourth quarter of 2021.
    • Initiation of NANORAY-312, a pivotal phase III global registration study evaluating NBTXR3 as a single-agent activated by radiotherapy for patients with LA-HNSCC expected late in the fourth quarter of 2021.

    Priority Pathway in Immunotherapy for Advanced Cancers, Priming Immune Response in Combination with Anti-PD-1 Treatment: Given early data showing anti-cancer immune activity triggered by its physical mechanism of action, Nanobiotix is evaluating the potential for NBTXR3 to improve current approaches to immunotherapy by combining NBTXR3 with anti-PD-1 therapies in advanced cancers to potentially increase the number of patients that respond to treatment and improve outcomes for patients regardless of their prior exposure to immune checkpoint inhibitors.

    • Updated data from Study 1100, a phase I basket study evaluating NBTXR3 activated by radiotherapy (RT) in combination with nivolumab or pembrolizumab in locoregional recurrent or recurrent metastatic HNSCC, lung metastasis from any primary tumor and/or liver metastasis from any primary tumor showed tumor regression in 76.9% of evaluable patients (n=13) regardless of prior anti-PD-1 exposure. Data from this ongoing study show NBTXR3 plus radiotherapy could potentially stimulate immune response and convert anti-PD-1 non-responders into responders.
    • Expect to provide updated data including approximately 16 evaluable patients at medical conference during the fourth quarter of 2021
    • Plan to initiate discussions with FDA regarding potential registration pathway for NBTXR3 immunotherapy combination in H2 2021
    • On-track to report recommended Phase II dose for each cohort in 2022

    Expanding NBTXR3 Opportunity, Collaborating with World-Class Partners to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:

    • Formed strategic partnership with LianBio to develop and commercialize NBTXR3 across tumor types and therapeutic combinations in China and other Asian markets. LianBio will participate in the Nanobiotix global phase III HNSCC registrational study by enrolling approximately 100 patients. In addition to the phase III head and neck cancer study, LianBio has committed to enrolling patients in four additional registrational studies conducted by Nanobiotix across indications and therapeutic combinations. Nanobiotix received a $20 million upfront payment and is entitled to receive up to an aggregate of $220 million in potential contingent, development and commercialization milestone payments along with tiered, low double-digit royalties based on net sales of NBTXR3 in the licensed territories.
    • Initiated fifth collaborator-led study at The University of Texas MD Anderson Cancer Center (MD Anderson). MD Anderson Collaboration now includes three Phase I and two Phase II clinical studies, including:
      • Phase I study evaluating NBTXR3 activated by radiation therapy (RT) for patients with non-small cell lung cancer (NSCLC) amenable to re-irradiation;
      • Phase I study evaluating NBTXR3 in combination with chemotherapy for patients with esophageal cancer;
      • Phase I study evaluating NBTXR3 as a single agent activated by RT for patients with pancreatic cancer; and
      • Two Phase II studies, each evaluating NBTXR3 in combination with anti-PD-1 for patients with head and neck cancer (inoperable locoregional recurrent amenable to reirradiation and recurrent metastatic with limited PD-L1 expression or refractory).
    • Presented preclinical data, developed in collaboration with MD Anderson, further suggesting that NBTXR3 could prime adaptive immune response and combine with several immune checkpoint inhibitors at the first American Association of Cancer Research (AACR) Virtual Special Conference on Radiation Science and Medicine. This data demonstrated that a combination therapy including NBTXR3, anti-PD-1, anti-TIGIT, and anti-LAG3 augmented anti-tumor response in both irradiated and unirradiated tumors, improving local and distant tumor control and increasing survival rate. The survivor mice were immune to re-injections of tumor cells, maintained significantly higher percentages of memory immune cells and stronger anti-tumor immune activities than control.
    • Reported first clinical results in rectal cancer including recommended phase II dose from the complete phase Ib part of a phase Ib/II study evaluating NBTXR3 activated by radiotherapy with concurrent chemotherapy at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI 2021). The data showed that the intra-tumoral injection of NBTXR3 was feasible and well tolerated at all dose levels. More than 70% of patients showed objective tumor response and approximately 90% of patients underwent total mesorectal excision (surgery), and 17.6% achieved pathological complete response.
    • Initiated one-year collaboration between Sanofi and Nanobiotix subsidiary, Curadigm, to establish proof-of concept for Curadigm's Nanoprimer as a combination product that could improve treatment outcomes for gene therapy product candidates.

    "Given our clinical and operational progress in the first half of 2021, we believe we are on track to deliver on the promise of NBTXR3 as a potential first-in-class, solid tumor-agnostic, combination-agnostic product candidate that could change treatment paradigms in oncology," said Laurent Levy, co-founder and chairman of the executive board of Nanobiotix. "As we prepare for the initiation of our pivotal phase III study later this year, we are highly encouraged by the consistently strong findings from our phase I expansion study in head and neck cancer presented earlier this year and eagerly anticipate reporting progression free survival and overall survival data from this study in the fourth quarter. Taken together with data we have reported on the potential of NBTXR3 in immunotherapy and the series of studies initiated by MD Anderson exploring NBTXR3 across additional solid tumor types and therapeutic combinations, we continue to achieve critical milestones on our journey to improve outcomes for patients throughout oncology."

    Financial Results for the First Half of 2021

    Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2021, were €102.3 million, expected to support development plans into the first quarter of 2023. This amount includes the €16.5 million ($20.0 million) upfront payment associated with the LianBio collaboration announced in May 2021. As previously announced, PharmaEngine was eligible for and received a €2.1 million ($2.5 million) payment following the announcement of the LianBio collaboration and has received €3.3 million ($4.0 million) in conjunction with the completion of various administrative steps in connection with the winding-up of the collaboration. PharmaEngine will be eligible to receive an additional $1.0 million in administrative fees, a final payment of $5 million upon a second regulatory approval of an NBTXR3-containing product as well as low-single digit royalties for a limited period following approval in the region.

    Revenue: Revenue for the first half of 2021 totaled €9.7 thousand compared to €36.9 thousand for the first half of 2020. Revenue for the six months ended June 30, 2021 and June 30, 2020 mainly corresponded to the charging back of cost incurred in connection with the Company previous collaboration with PharmaEngine, Inc.

    Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended June 30, 2021, were €15.5 million, compared to €13.1 million for the six months ended June 30, 2020. Purchases, sub-contracting and other expenses increased by €2.3 million for the six months ended June 30, 2021 as compared with the same period in 2020. This increase reflects the impact of COVID-19 pandemic in 2020 and the Company's focus on advancing its clinical trial development priorities in 2021.

    Selling, General and Administrative ("SG&A") Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the six months ended June 30, 2021, were €10.2 million, compared to €6.8 million for the prior-year six-month period. This increase of €3.4 million was primarily due to expenses relating to partnership agreements as well as consulting fees, legal & compliance expenses following the Company's Nasdaq listing, and recruitment expenses.

    Net loss: Net loss attributable to common shareholders for the six months ended June 30, 2021 was €30.4 million, or €0.88 per share. This compares to a net loss attributable to common shareholders of €20.6 million, or €0.91 per share, for the same period in 2020. The €9.8 million increase in net loss compared to the first half of 2020 was primarily driven by the €5.4 million in operating expenses associated with the termination of the PharmaEngine agreement during the first half of 2021.

    These results are represented in the condensed consolidated financial statements as of June 30, 2021, approved by the executive board of the Company on September 8, 2021, and reviewed by the supervisory board of the Company on the same date, and have been subjected to a limited review by the Company's statutory auditors.

    Availability of the half-year financial report

    The 2021 half-year financial report has been filed with the French Financial markets authority (Autorité des marchés financiers). It is available to the public and can be consulted on the company's website, www.nanobiotix.com.

    Updated Financial Agenda

    October 20th, 2021: Third Quarter Corporate and Financial Update

    ***

    About NBTXR3

    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'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.

    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; and a phase III global registrational study is planned to launch in 2021. 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—the same population being evaluated in the planned phase III study.

    Nanobiotix has also prioritized an Immuno-Oncology development program—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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners 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.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. 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.

    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–NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter.

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. 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 preclinical or early clinical result 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors", those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers or "AMF") under number D.21-0272 on April 7, 2021 (a copy of which is available on www.nanobiotix.com), as well as those set forth in the half-year financial report filed with the AMF 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.

    Nanobiotix S.A.

    Condensed Consolidated Statements of Operations

    (unaudited)

    (in thousands, except share and per share amounts)

     
    For the six month period ended
    June 30, 2021 June 30, 2020
    Revenues and other income
    Revenues

    10

     

    37

     

    Other income

    1,309

     

    1,411

     

    Total revenues and other income

    1,319

     

    1,448

     

    Research and development expenses

    -15,506

     

    -13,077

     

    Selling, general and administrative expenses

    -10,176

     

    -6,755

     

    Other operating income and expenses

    -5.414

     

     

    Total operating expenses

    -31,096

     

    -19,832

     

    Operating income (loss)

    -29,778

     

    -18,384

     

    Financial income

    2,511

     

    234

     

    Financial expenses

    -3,152

     

    -2,428

     

    Financial income (loss)

    -640

     

    -2,194

     

    Income tax

    -2

     

    -1

     

    Net loss for the period

    -30,420

     

    -20,579

     

    Basic loss per share (euros/share)

    (0.88

    )

    (0.91

    )

    Diluted loss per share (euros/share)

    (0.88

    )

    (0.91

    )

    Condensed Consolidated Balance Sheet Data
    (unaudited)
    (in thousands)
     
    As of
    June 30, 2021 December 31, 2020
    Total non-current assets

    8,045

    8,782

    - Cash and Cash equivalents

    102,336

    119,151

    Total current assets

    115,870

    125,248

    TOTAL ASSETS

    123,915

    134,030

    - Net loss for the period

    -30,420

    -33,590

    Total shareholders' equity

    41,431

    70,468

    Total non-current liabilities

    44,445

    44,522

    Total current liabilities

    38,038

    19,041

    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

    123,915

    134,030

    ____________________

    1 These percentages include one patient recorded by the principal investigator in the Clinical Observation Record as Unconfirmed Complete Response.

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  2. Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, Chief Executive Officer, will present the Company's latest corporate and clinical developments during a webcast at the virtual H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on-demand starting at 7:00 AM EDT / 1:00 PM CET on Monday, September 13, 2021.

    A webcast of the event will be available for 90 days on the events section of the Company's website.

    About NANOBIOTIX:

    Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches…

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, Chief Executive Officer, will present the Company's latest corporate and clinical developments during a webcast at the virtual H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on-demand starting at 7:00 AM EDT / 1:00 PM CET on Monday, September 13, 2021.

    A webcast of the event will be available for 90 days on the events section of the Company's website.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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– NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter.

    View Full Article Hide Full Article
    • Presented updated results from priority pathways in head and neck cancer and immunotherapy for potential first-in-class radioenhancer NBTXR3 at 2021 Annual Meeting of The American Society for Clinical Oncology
    • Established new strategic partnership with LianBio to develop and commercialize NBTXR3 across tumor types and therapeutic combinations in China and other Asian markets
    • Strengthened global leadership team through the appointment of Dr. Gary Phillips as Chairman of the Nanobiotix Supervisory Board and Bart Van Rhijn as Chief Financial Officer
    • Reported €102.3 million in cash, cash equivalents, and short-term investments as of June 30, 2021

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX) (Paris:NANO) (NASDAQ:NBTX), a late-clinical stage…

    • Presented updated results from priority pathways in head and neck cancer and immunotherapy for potential first-in-class radioenhancer NBTXR3 at 2021 Annual Meeting of The American Society for Clinical Oncology
    • Established new strategic partnership with LianBio to develop and commercialize NBTXR3 across tumor types and therapeutic combinations in China and other Asian markets
    • Strengthened global leadership team through the appointment of Dr. Gary Phillips as Chairman of the Nanobiotix Supervisory Board and Bart Van Rhijn as Chief Financial Officer
    • Reported €102.3 million in cash, cash equivalents, and short-term investments as of June 30, 2021

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX) (Paris:NANO) (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced operational progress and cash position (unaudited) for the second quarter of 2021.

    Second Quarter Financial Updates

    Nanobiotix reported total revenue for the six-month period ended June 30, 2021 of €9.7k. Revenue for the first half of 2021 was primarily driven by cross charges related to the Company's previous collaboration with PharmaEngine, Inc., during the first quarter 2021. Nanobiotix did not generate any revenue during the second quarter of 2021. Revenue for the second quarter and first half of 2020 amounted to €13.4k and €36.9k respectively.

    Nanobiotix reported cash, cash equivalents, and short-term investments totaling €102.3 million as of June 30, 2021, compared to €107.1 million as of March 31, 2021. This amount includes the €16.5 million ($20.0 million) upfront payment associated with the LianBio collaboration announced in May 2021. As previously announced, PharmaEngine was eligible for and received a €2.1 million ($2.5 million) payment following the announcement of Nanobiotix's collaboration with LianBio and has received €3.4 million ($4.0 million) in conjunction with the completion of various administrative steps in connection with the winding-up of the collaboration. PharmaEngine will be eligible to receive an additional $1.0 million in administrative fees and a final payment of $5 million upon a second regulatory approval of an NBTXR3-containing product.

    Nanobiotix plans to report half-year financial results for the six-months ended June 30, 2021, including condensed consolidated financial statements for the period, on September 8, 2021.

    Second Quarter Operational Highlights

    • Presented Updated Results from Priority Pathways in Head and Neck Cancer and Immunotherapy for Potential First-In-Class Radioenhancer NBTXR3 at 2021 Annual Meeting of The American Society for Clinical Oncology (ASCO):
      • Local Control as a Single-Agent for Patients with Head and Neck Cancer: Updated data from Study 102, a phase I study evaluating NBTXR3 as a single agent activated by radiotherapy in locally advanced head and neck squamous cell carcinoma (LA- HNSCC) presented at ASCO further support NBTXR3 administration as feasible, and well-tolerated with a favorable safety profile in highly vulnerable elderly LA-HNSCC patients with high unmet medical needs and significant burden of disease. At a median follow up of 8.1 months, evaluable patients (n=40) demonstrated a high primary tumor ORR of 82.5% and a 62.5% CRR. These results are consistent with those observed in the dose escalation part of the study and suggest durability of efficacy. Nanobiotix plans to launch a pivotal phase III global registration study evaluating NBTXR3 as a single-agent activated by radiotherapy for patients with LA-HNSCC in the second half of 2021.
      • Priming Immune Response and Immunotherapy Combination Across Oncology:Updated data from Study 1100, a phase I basket study evaluating NBTXR3 activated by radiotherapy (RT) in combination with nivolumab or pembrolizumab in locoregional recurrent or recurrent metastatic HNSCC, lung metastasis from any primary tumor and/or liver metastasis from any primary tumor showed tumor regression in 76.9% of evaluable patients (n=13) regardless of prior anti-PD-1 exposure. Data from this ongoing study show NBTXR3 plus radiotherapy could potentially stimulate immune response and convert anti-PD-1 non-responders into responders.
    • Formed Strategic Partnership with LianBio to Develop and Commercialize NBTXR3 Across Tumor Types and Therapeutic Combinations in China and other Asian markets:
      • LianBio's cross-border development and commercialization expertise includes strong capabilities in oncology: LianBio will participate in the Nanobiotix global phase III HNSCC registrational study by enrolling 100 patients in China. In addition to the phase III head and neck cancer study, LianBio has committed to enrolling patients in four additional registrational studies conducted by Nanobiotix across indications and therapeutic combinations. Under the terms of the agreement, LianBio will obtain exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore, and Thailand. Nanobiotix received a $20 million upfront payment and is entitled to receive up to an aggregate of $220 million in potential contingent, development and commercialization milestone payments along with tiered, low double-digit royalties based on net sales of NBTXR3 in the licensed territories.
    • Strengthened Board & Leadership Team to Focus Efforts on Advancing Its Global Development Strategy:
      • Named Gary Phillips, MD, as the new chairman of the Company's supervisory board: Dr. Phillips, who is the president and chief executive officer of OrphoMed, Inc., brings decades of experience in the pharmaceutical and healthcare industries where he has led commercial operations, clinical medicine, business strategy, and development functions.
      • Appointed Bart Van Rhijn, MBA, as chief financial officer and member of the Company's executive board: Mr. Van Rhijn brings extensive experience in consultancy, technology, and life sciences industries and joins Nanobiotix after nearly 3 years as chief financial officer at Servier Pharmaceuticals, LLC (Servier US). Prior to Servier US, he held leadership roles in prominent organizations in Europe and North America, including PricewaterhouseCoopers, Philips and Galderma, including Head of Tax, Senior Director of Mergers and Acquisitions, and Head of Finance positions.

    Updated Financial Agenda

    September 8: Half-Year Corporate and Financial Update

    October 20th: Third Quarter Corporate and Financial Update

    ***

    About NBTXR3

    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'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.

    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; and a phase III global registrational study is planned to launch in 2021. 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—the same population being evaluated in the planned phase III study.

    Nanobiotix has also prioritized an Immuno-Oncology development program—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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners 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 (MD Anderson) for MD Anderson to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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–NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. 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 preclinical or early clinical result 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.21-0272 on April 7, 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.

    View Full Article Hide Full Article
    • First patient administered radiotherapy in phase I study evaluating NBTXR3 as a single-agent activated by radiotherapy in patients with non-small cell lung cancer amenable to re-irradiation

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the initiation of a new phase I study evaluating NBTXR3 activated by radiation therapy (RT) for patients with non-small cell lung cancer (NSCLC) amenable to re-irradiation. The phase I is among five collaborator-led studies that are active and recruiting at The University of Texas MD Anderson Cancer Center (MD Anderson), and the third to enroll its first patient…

    • First patient administered radiotherapy in phase I study evaluating NBTXR3 as a single-agent activated by radiotherapy in patients with non-small cell lung cancer amenable to re-irradiation

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the initiation of a new phase I study evaluating NBTXR3 activated by radiation therapy (RT) for patients with non-small cell lung cancer (NSCLC) amenable to re-irradiation. The phase I is among five collaborator-led studies that are active and recruiting at The University of Texas MD Anderson Cancer Center (MD Anderson), and the third to enroll its first patient.

    "Our ongoing collaboration with MD Anderson remains a critical component of our strategy as we seek to develop NBTXR3 as a solid tumor-agnostic, therapeutic combination-agnostic agent with the potential to change the practice of radiotherapy and immunotherapy," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "These collaborator-led studies not only provide patients with significant unmet need the opportunity to benefit from MD Anderson's physicians, but also provide additional capacity for Nanobiotix to expand development of NBTXR3 into indications where innovation is urgently needed while remaining focused internally on our priority pathways in head and neck cancer and immunotherapy."

    A Phase I Study of Reirradiation with NBTXR3 for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer

    This phase I study, led by Saumil Gandhi, Assistant Professor, Department of Radiation Oncology, Division of Radiation Oncology, MD Anderson, investigates the safety and optimal dose of NBTXR3 when activated by radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). The study has a two-cohort, open label design consisting of two parts: (i) RT safety lead-in cohort recruiting up to 10 patients and NBTXR3 activated by RT dose-finding cohort recruiting up to 12 patients; and (ii) expansion at the recommended phase II dose (RP2D) with toxicity monitoring recruiting 12 patients. The dose levels explored to be explored are 22% and 33% of baseline gross tumor volume. The planned enrollment period is up to three years.

    The patient population includes adults (age ≥ 18 years) with medically inoperable NSCLC with overlap between recurrent disease in need of treatment and prior RT. Given the design of the study, patients in the first cohort in part one will receive RT and be monitored for safety before the second cohort is opened where patients will receive injections of NBTXR3.

    Five Studies Now Active and Recruiting in Clinical Collaboration

    In addition to the lung cancer study described above, two phase II studies, each evaluating NBTXR3 in combination with anti-PD-1 for patients with head and neck cancer (inoperable locoregional recurrent amenable to reirradiation and recurrent metastatic with limited PD-L1 expression or refractory); one phase I study evaluating NBTXR3 in combination with chemotherapy for patients with esophageal cancer; and one phase I study evaluating NBTXR3 as a single-agent activated by RT for patients with pancreatic cancer are active and enrolling. As previously announced, the first patient has been injected with NBTXR3 in each of the esophageal cancer and pancreatic cancer studies. The first NBTXR3 injections in the phase II head and neck cancer studies are expected in the second half of 2021. All studies in the collaboration are led by MD Anderson and milestones will be reported as they are made available by the institution.

    Next Steps for Collaborator-led Expansion of NBTXR3 Development as a Potentially Solid Tumor-Agnostic and Therapeutic Combination-Agnostic Agent

    The clinical collaboration between Nanobiotix and MD Anderson is a collaborator-led expansion of the NBTXR3 development pipeline across indications and therapeutic combinations. One additional study evaluating NBTXR3 in combination with anti-CTLA-4 and anti-PD-1/L1 plus RadScopal™ in advanced solid tumors with lung or liver metastasis is planned to launch in the second half of 2021. Further studies evaluating the potential of NBTXR3 to address unmet needs throughout the oncology landscape are in discussion as part of the collaboration agreement and updates will be provided as the planning process evolves.

    ***

    About NBTXR3

    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'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.

    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; and a phase III global registrational study is planned to launch in the second half of 2021. 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—the same population being evaluated in the planned phase III study.

    Nanobiotix has also prioritized an Immuno-Oncology development program—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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners 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.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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–NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. 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 preclinical or early clinical result 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.21-0272 on April 7, 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.

    View Full Article Hide Full Article
  3. Regulatory News:

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that it will host a virtual KOL event for analysts, investors, and the scientific community on Friday, June 11, 2021 at 8AM ET / 2PM CET. The event will feature several key opinion leaders, including current study investigators.

    The Nanobiotix KOL event will provide an in-depth review of the immunotherapy data presented at the 2021 Annual Meeting of American Society for Clinical Oncology (ASCO) along with clinical perspectives on the implications of potential first-in-class radioenhancer NBTXR3 across the oncology landscape…

    Regulatory News:

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that it will host a virtual KOL event for analysts, investors, and the scientific community on Friday, June 11, 2021 at 8AM ET / 2PM CET. The event will feature several key opinion leaders, including current study investigators.

    The Nanobiotix KOL event will provide an in-depth review of the immunotherapy data presented at the 2021 Annual Meeting of American Society for Clinical Oncology (ASCO) along with clinical perspectives on the implications of potential first-in-class radioenhancer NBTXR3 across the oncology landscape.

    Registration for the event is now open on the events section of the Company's website. A live webcast of the discussion and an archived recording will be available on the events section as well.

    Nanobiotix Virtual KOL Event Program

    Can NBTXR3 Turn Anti-PD-1 Non-responders into Responders and Deepen Response in Naïve Patients?

    Agenda:

    • Opening Remarks (8:00AM ET / 2:00PM CET)
      • Presented by Jeffrey Bockman, PhD, EVP and Oncology Practice Head, Cello Health BioConsulting
    • NBTXR3 Mode of Action (8:05AM ET / 2:05PM CET)
      • Presented by Laurent Levy, PhD, co-founder and CEO, Nanobiotix
    • Overview of the Treatment Landscape: Promise and Limitations of Immunotherapy, and Rationale for Combination-based Approaches (8:10AM ET / 2:10PM CET)
      • Presented by Jared Weiss, MD, Associate Professor of Medicine, Division of Oncology, University of North Carolina Lineberger Comprehensive Cancer Center
    • Nanobiotix Study 1100 Safety and Efficacy Data Update (8:20AM ET / 2:20PM CET)
      • Presented by Tanguy Seiwert, MD, Assistant Professor of Oncology, Director, Head and Neck Cancer Oncology Disease Group, Johns Hopkins Medicine and Colette Shen, MD, PhD, Assistant Professor, Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center
    • NBTXR3 as a Potential Combination-agnostic Product, Rationale, and Future Opportunity (8:40AM ET / 2:20PM CET)
      • Presented by James Welsh, MD, Associate Professor, Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
    • Discussion and Q&A, Implications of Study 1100 in Head and Neck Cancer and Beyond (8:50AM ET / 2:50PM CET)
      • Panel Discussion Moderated by Jeffrey Bockman
    • Summary Close (9:10AM ET / 3:10PM CET)
      • Presented by Jeffrey Bockman

    ***

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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–NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. 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 preclinical or early clinical result 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.21-0272 on April 7, 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.

    View Full Article Hide Full Article
  4. Data to be Presented at the 2021 Annual Meeting of the American Society for Clinical Oncology

    • Results show NBTXR3 plus radiotherapy could potentially stimulate immune response and convert anti-PD-1 non-responders into responders
    • Objective response was observed in 60% of anti-PD-1 naïve patients and 50% of prior non-responders
    • Data suggest abscopal effect in some patients (i.e., reduction in non-injected / non-irradiated lesions)
    • To date, the overall adverse event profile for the 16 injected patients has not differed from what is expected with radiotherapy or anti-PD-1 agents (head and neck cancer and non-small cell lung cancer primary tumors)
    • New readout could provide promising signals for NBTXR3 as a potential pillar of immunotherapy…

    Data to be Presented at the 2021 Annual Meeting of the American Society for Clinical Oncology

    • Results show NBTXR3 plus radiotherapy could potentially stimulate immune response and convert anti-PD-1 non-responders into responders
    • Objective response was observed in 60% of anti-PD-1 naïve patients and 50% of prior non-responders
    • Data suggest abscopal effect in some patients (i.e., reduction in non-injected / non-irradiated lesions)
    • To date, the overall adverse event profile for the 16 injected patients has not differed from what is expected with radiotherapy or anti-PD-1 agents (head and neck cancer and non-small cell lung cancer primary tumors)
    • New readout could provide promising signals for NBTXR3 as a potential pillar of immunotherapy
    • Following ASCO, Nanobiotix will host an investor event on Friday, June 11, 2021 at 8:00 am Eastern Time (14:00 Central European Time), to provide an in-depth review of the immunotherapy data with several key opinion leaders including study investigators (Register here)

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210603005997/en/

    Spider Plot – anti-PD-1 Naïve Patients (Graphic: Business Wire)

    Spider Plot – anti-PD-1 Naïve Patients (Graphic: Business Wire)

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the upcoming presentation of updated data from the Company's immunotherapy development pathway at the 2021 Annual Meeting of the American Society for Clinical Oncology (ASCO).

    Cancer immunotherapies such as anti-PD-1 have shown promising clinical outcomes over the past two decades and are often used to treat advanced cancers once other therapies have reached the end of their effectiveness. However, across tumor indications, the significant majority of patients (80-85% according to published data) receive only a temporary benefit—or no benefit at all—from anti-PD-1, as they either develop resistance to the therapy over time or are non-responsive to treatment altogether.

    "Improving response rates to immune checkpoint inhibitors is currently a key challenge for the medical and scientific community," said Tanguy Seiwert, MD, director of the head and neck oncology disease group at Johns Hopkins Medicine. "The data we have seen to date suggest that NBTXR3 could bring a completely different local and systemic approach to overcoming this barrier in immunotherapy."

    Given early data showing immune activity triggered by the physical mechanism of action of radiotherapy-activated NBTXR3, Nanobiotix aims to address the significant unmet need in cancer immunotherapy by combining NBTXR3 plus radiotherapy with anti-PD-1 in advanced cancers to potentially improve treatment outcomes for patients regardless of their prior exposure to immune checkpoint inhibitors.

    "Changing the practice of immunotherapy is a challenge requiring innovation that can address unmet needs in the first-line for patients with primary resistance and in later lines for secondary resistance," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "While our overall strategy is to develop NBTXR3 as a solid tumor-agnostic, therapeutic combination-agnostic agent, this particular study is designed to address both challenges by evaluating NBTXR3 plus radiotherapy in combination with anti-PD-1 across advanced cancer indications for both anti-PD-1 naïve patients and prior non-responders. The update we will present at ASCO adds to our growing body of data regarding our radioenhancer as a potential primer of immune response that could combine with anti-PD-1 and other checkpoint inhibitors to improve treatment outcomes for millions of patients."

    Priming Immune Response and Immunotherapy Combination in Advanced Cancers

    Abstract #2590: A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

    Background

    The Nanobiotix phase I study of NBTXR3 activated by radiotherapy for patients with advanced cancers treated with an anti-PD-1 therapy (Study 1100), is a multicenter, open-label, non-randomized phase I dose escalation with dose expansion study to establish the recommended phase II dose (RP2D) of NBTXR3 plus radiotherapy in combination with anti-PD-1 in three (3) cohorts: (i) inoperable locoregional recurrent or recurrent and metastatic head and neck cancer (R/M head and neck squamous cell carcinoma; R/M HNSCC); (ii) lung metastasis; (iii) liver metastasis. The study is being administered in the United States.

    The secondary endpoints are objective response rate (ORR), safety and feasibility, and body kinetic profile.

    Updated Results

    Safety

    NBTXR3 administration by intratumoral injection was feasible and well-tolerated. To date, the overall adverse event (AE) profile has not differed from what is expected with radiotherapy or anti-PD-1 agents. 16 serious AEs were observed, of which four (4) were identified as NBTXR3 or injection related.

    Efficacy

    As of the data cut-off, 16 patients in the study received NBTXR3 plus radiotherapy and 13 were evaluable for response. Tumor regression was observed in 76.9% (10/13) of evaluable patients, regardless of prior anti-PD-1 exposure. The study reported tumor regression in 80% (4/5) of anti-PD-1 naïve patients and 60% (3/5) had investigator-assessed objective response, including one (1) complete response according to response evaluation criteria outlined in RECIST 1.1. In patients with prior primary or secondary resistance to anti-PD-1, 75% (6/8) had tumor regression and 50% (4/8) had investigator-assessed objective response. These included one (1) complete response and two (2) partial responses by RECIST 1.1, along with one (1) additional investigator-assessed pathological complete response. Some patients in the study showed delayed tumor response and/or abscopal effect, suggesting NBTXR3 may potentially prime an immune response.

    Spider Plot – anti-PD-1 Naïve Patients (see table 1)

    Spider Plot – anti-PD-1 Refractory Patients (see table 2)

    "These updated data support the potential for NBTXR3 plus radiotherapy in combination with anti-PD-1 to yield a sustained immune response in both anti-PD-1 naïve patients and patients that have progressed on prior anti-PD-1 therapy," concluded Colette Shen, MD, PhD, an assistant professor of radiation oncology at the University of North Carolina Lineberger Comprehensive Cancer Center and Study 1100 presenting investigator at ASCO. "NBTXR3 plus radiotherapy could stimulate immune response, convert anti-PD-1 non-responders into responders, and could be a promising next step for patients who develop immune checkpoint inhibitor resistance."

    Swimmer Plot – anti-PD-1 Refractory Patients Follow-up (see table 3)

    Nanobiotix Investor Event

    Nanobiotix will host a virtual investor event featuring several key opinion leaders, including study investigators, after the ASCO Annual Meeting on Friday, June 11, 2021 at 8:00 am Eastern Time (14:00 Central European Time). The discussion will focus on the new immunotherapy data from Study 1100. Register here.

    About NBTXR3

    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'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.

    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; and a phase III global registrational study is planned to launch in 2021. 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—the same population being evaluated in the planned phase III study.

    Nanobiotix has also prioritized an Immuno-Oncology development program—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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners 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.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. 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.

    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—NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter.

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. 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 preclinical or early clinical result 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.21-0272 on April 7, 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.

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  5. Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the appointment of Bart Van Rhijn, MBA, as chief financial officer and member of the Company's executive board. Mr. Van Rhijn brings proven capabilities in global financial management, business development and pharmaceutical commercialization as the Company prepares for the planned launch of its second clinical registration study for potential first-in-class radioenhancer NBTXR3 in head and neck cancer (NANORAY-312), continued development in immunotherapy, and planned expansion across solid tumor types and therapeutic combinations. He succeeds…

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the appointment of Bart Van Rhijn, MBA, as chief financial officer and member of the Company's executive board. Mr. Van Rhijn brings proven capabilities in global financial management, business development and pharmaceutical commercialization as the Company prepares for the planned launch of its second clinical registration study for potential first-in-class radioenhancer NBTXR3 in head and neck cancer (NANORAY-312), continued development in immunotherapy, and planned expansion across solid tumor types and therapeutic combinations. He succeeds Philippe Mauberna, who will step down from his roles as chief financial officer and executive board member after 8 years of service to the Company. Mr. Mauberna will assume a temporary role to support the organization during transition.

    "Joining Nanobiotix as its CFO is a true honor," said Mr. Van Rhijn. "I look forward to collaborating with the executive team and the organization at-large to help unlock and capture value with potentially practice-changing technology platforms. The opportunity to make a meaningful contribution to the lives of so many patients, caregivers and healthcare providers is humbling and carries great responsibility."

    Mr. Van Rhijn brings extensive experience in consultancy, technology, and life sciences industries and joins Nanobiotix after nearly 3 years as chief financial officer at Servier Pharmaceuticals, LLC (Servier US). Prior to Servier US, he held leadership roles in prominent organizations in Europe and North America, including PricewaterhouseCoopers, Philips and Galderma in Head of Tax, Senior Director of Mergers and Acquisitions, and Head of Finance positions. Mr. Van Rhijn's track record reflects a relentless commitment to streamlining business operations, driving growth, and unlocking value. His varied experiences include the successful reorganization of a healthcare technology-enabled services business, coordination of strategic financing transactions, and the efficient scaling of commercial businesses. Mr. Van Rhijn has a strong commitment to organizational health and empowers his teams to embrace innovation, challenge the status quo, and drive optimal results while putting patients and customers first.

    Mr. Van Rhijn received master's degrees in Civil Law and Tax Law at Leiden University, The Netherlands, obtained his MBA with honors from Babson's Olin School of Management, and his Certified Management Accountant (CMA) certification from the Institute of Management Accounts. In addition, Mr. Van Rhijn serves on the Advisory Board of a Boston-based healthcare start-up and is a venture partner at an emerging technology fund.

    "As Nanobiotix advances toward potential global commercialization it is critical that we continue to globalize our executive management and diversify our leadership expertise," said Nanobiotix co-founder and chief executive officer Laurent Levy. "Bart Van Rhijn brings critical competencies in commercialization at-scale that we believe will enable us to realize the potential benefits of our novel technologies and reach patients around the world. I know I speak for everyone at Nanobiotix in offering heartfelt thanks to Philippe Mauberna. His tireless effort on behalf of patients, their families, Nanobiotix team members, and shareholders have been instrumental in the growth of our company over the past 8 years. We wish Philippe the best in his future pursuits."

    Philippe Mauberna joined Nanobiotix as chief financial officer in May 2013 and was appointed to the executive board in August 2013. In his time with the company, Nanobiotix became one of only seven French biotech companies dual-listed on Euronext: Paris and Nasdaq; launched its first pivotal phase III clinical registration study for NBTXR3; and attained a European market approval for NBTXR3 (Hensify®) in soft tissue sarcoma. Mr. Mauberna's leadership also helped the company more than double in size over the course of his tenure and enabled the creation of the Company's subsidiaries in Europe and in the United States.

    About NBTXR3

    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'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, including, in particular, immune checkpoint inhibitors.

    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; and a phase III global registrational study is planned to launch in 2021. 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—the same population being evaluated in the planned phase III study.

    Nanobiotix has also prioritized an Immuno-Oncology development program—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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy 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.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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—NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter.

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. 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 preclinical or early clinical result 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.21-0272 on April 7, 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.

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  6. Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, co-founder and chief executive officer, will discuss the Company's latest corporate and clinical developments in a fireside chat at the Jefferies Virtual Healthcare Conference on the 4th of June at 8:00 AM Eastern Time (14:00 Central European Time).

    A live webcast of the discussion, as well as an archived recording may be accessed by visiting the events section of the Company's website.

    ***

    About NANOBIOTIX

    Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches…

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, co-founder and chief executive officer, will discuss the Company's latest corporate and clinical developments in a fireside chat at the Jefferies Virtual Healthcare Conference on the 4th of June at 8:00 AM Eastern Time (14:00 Central European Time).

    A live webcast of the discussion, as well as an archived recording may be accessed by visiting the events section of the Company's website.

    ***

    About NANOBIOTIX

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France, and has subsidiaries in Cambridge, Massachusetts (United States) as well as France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City in December 2020.

    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–NBTXR3—which is th eproduct 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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    View Full Article Hide Full Article
  7. Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Gary Phillips, MD, has been appointed as the new chairman of the Company's supervisory board. Dr. Phillips succeeds Laurent Condomine, who will retire from the supervisory board after 11 years of leadership. Dr. Phillips will provide extensive guidance as the Company continues to advance its global development strategy with its planned second clinical registration pathway in head and neck cancer and its immunotherapy pathway as key focus areas.

    "I am truly honored and excited by my appointment as chairman of the Nanobiotix supervisory board…

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Gary Phillips, MD, has been appointed as the new chairman of the Company's supervisory board. Dr. Phillips succeeds Laurent Condomine, who will retire from the supervisory board after 11 years of leadership. Dr. Phillips will provide extensive guidance as the Company continues to advance its global development strategy with its planned second clinical registration pathway in head and neck cancer and its immunotherapy pathway as key focus areas.

    "I am truly honored and excited by my appointment as chairman of the Nanobiotix supervisory board," said Dr. Phillips. "I look forward to working with the board and the entire organization toward delivering the breakthrough promise of its potentially transformational technology. Overcoming cancer and other major diseases is an absolute necessity for patients, their families and health care providers, and I believe we have the opportunity to expand treatment possibilities for their benefit."

    Dr. Phillips, who is currently president and chief executive officer of OrphoMed, Inc. (OrphoMed), in the United States, brings decades of experience in the pharmaceutical and healthcare industries where he has led commercial operations, clinical medicine, business strategy, and development functions. Before joining OrphoMed in 2018, Dr. Phillips worked with Mallinckrodt Pharmaceuticals, where he had served as Executive Vice President and Chief Strategy Officer since 2013. Prior to that role, he was Head of Global Health & Healthcare Industries at the World Economic Forum, served as President of Reckitt Benckiser Pharmaceuticals North America (now Indivior), and held dual roles as President, U.S. Surgical and Pharmaceuticals and Global Head of Pharmaceuticals at Bausch & Lomb. In addition, Dr. Phillips has served in executive roles at Merck Serono, Novartis, and Wyeth.

    Dr. Phillips earned a B.A. in Biochemistry with Summa Cum Laude and Phi Beta Kappa distinctions from the College of Arts and Sciences at the University of Pennsylvania, an MBA from the Wharton School at the University of Pennsylvania, and an M.D. with Alpha Omega Alpha distinction from the School of Medicine at the University of Pennsylvania. Dr. Phillips maintains an active medical license and practiced as a general medicine clinician/officer in the U.S. Navy, from which he was honorably discharged as a lieutenant commander.

    "We are pleased to welcome Dr. Gary Phillips to the Nanobiotix supervisory board at this pivotal moment for the Company," said Nanobiotix co-founder and chief executive officer Laurent Levy. "His wealth of experience within the global pharmaceutical industry will be instrumental in supporting our continued expansion as we move toward commercialization and pursue the realization of our goal to revolutionize treatment for millions of patients around the world through physics. On behalf of the Nanobiotix team, I also offer deep gratitude to Laurent Condomine. I have no doubt that the successes we have achieved together for patients, shareholders, and team members would not have been possible without his clarity of vision and steadfast leadership over the past 11 years."

    Laurent Condomine joined the Nanobiotix supervisory board in September 2010 after serving as the Vice President of Business Development for AstraZeneca in London, where he was responsible for developing corporate strategy and delivering external growth. Mr. Condomine's tenure as chairman of the Nanobiotix supervisory board coincided with several significant milestones for the company, including its listing on Euronext: Paris in 2012, the 2014 launch of the first pivotal registration study for first-in-class radioenhancer NBTXR3 in soft tissue sarcoma, market authorization in Europe of NBTXR3 (Hensify®) for the treatment of soft tissue sarcoma in 2019, and listing on the Nasdaq Global Select Market in 2020.

    "Many thanks to the marvelous people committed to making a difference for humanity on the Nanobiotix team," said Laurent Condomine. "It has been a great pleasure to help guide this company that could potentially save many lives through a novel, physics-based approach. When I joined the Company over a decade ago, we were in the early stages of transforming disruptive concepts into clinical applications, and I am proud of the progress we have made in bringing our technology toward broad availability for patients around the world. It was particularly rewarding to publish the interim results from the Company's first pivotal registration study, providing proof of concept for our science and the foundational support for European market approval in soft tissue sarcoma. I am leaving Nanobiotix, as I believe it is good corporate practice to pass the baton of supervisory board chairmanship after 10 years; however, the team will always have a special place in my heart, and I look forward to the Company's ongoing success."

    About NBTXR3

    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'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.

    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; and a phase III global registrational study is planned to launch in 2021. 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—the same population being evaluated in the planned phase III study.

    Nanobiotix has also prioritized an Immuno-Oncology development program—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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners 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.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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–NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the execution of the Company's development and commercialization strategies. 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 studies may not generate favorable data notwithstanding positive preclinical or 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.21-0272 on April 7, 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.

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    • Updated results from phase I dose expansion in head and neck cancer showed durable signs of efficacy at a median follow up of 8.1 months, with an overall objective response rate of 82.5% and a complete response rate of 62.5%
    • Data from the expansion part of the study continue to support NBTXR3 as feasible and well-tolerated in highly vulnerable patients with high unmet needs and significant burden of disease
    • Updates to immunotherapy data that have supported NBTXR3 plus anti-PD-1 as a potential option to yield sustained immune response in patients with locally advanced or metastatic tumors, regardless of prior anti-PD-1 exposure, will be reported prior to the conference
    • Following ASCO, Nanobiotix will host an investor event on Friday, June…
    • Updated results from phase I dose expansion in head and neck cancer showed durable signs of efficacy at a median follow up of 8.1 months, with an overall objective response rate of 82.5% and a complete response rate of 62.5%
    • Data from the expansion part of the study continue to support NBTXR3 as feasible and well-tolerated in highly vulnerable patients with high unmet needs and significant burden of disease
    • Updates to immunotherapy data that have supported NBTXR3 plus anti-PD-1 as a potential option to yield sustained immune response in patients with locally advanced or metastatic tumors, regardless of prior anti-PD-1 exposure, will be reported prior to the conference
    • Following ASCO, Nanobiotix will host an investor event on Friday, June 11, 2021 at 8am ET, to provide an in-depth review of the immunotherapy results with several key opinion leaders including study investigators (Register here)

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the upcoming presentation of updated results from the Company's priority development pathways in head and neck cancer (head and neck squamous cell carcinoma; HNSCC) and in immunotherapy for advanced cancers at the 2021 Annual Meeting of the American Society for Clinical Oncology (ASCO). The Company will also present a poster with long-term safety analysis from its pivotal phase II/III study in soft tissue sarcoma.

    "The data we will present at ASCO provide further support for the paradigm-shifting potential of NBTXR3 as a foundational solid tumor-agnostic and combination-agnostic cancer therapeutic," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "We are excited to present both long-term safety data from our phase III soft tissue sarcoma study, along with updated safety and efficacy data from our second single-agent registration pathway in head and neck cancer. Moreover, we are particularly eager to present a growing body of data suggesting that after activation by radiotherapy, NBTXR3 may prime an immune response that could enhance the efficacy of immune checkpoint inhibitors as a first-line therapy, overcome resistance for refractory patients, and meaningfully expand the tumor types that respond to the class by transforming cold tumors into hot tumors."

    Local Control as a Single-Agent for Patients with Head and Neck Cancer

    Abstract #6051: Phase I Dose Expansion Study of Functionalized Hafnium Oxide Nanoparticles (NBTXR3) in Cisplatin-Ineligible Locally Advanced HNSCC Patients

    The number of elderly patients diagnosed with locally advanced HNSCC (LA-HNSCC) is increasing. While concurrent chemoradiation is the non-surgical standard of care, not all patients can tolerate platinum-based chemotherapy (e.g., cisplatin). The Nanobiotix phase I dose expansion study in patients with LA-HNSCC (Study 102) is evaluating a single dose of NBTXR3 at 22% of baseline tumor volume (the recommended phase II dose; RP2D). Primary endpoints of the study are objective response rate (ORR) and complete response rate (CRR) of the primary tumor. Study 102 is expected to recruit a total of 44 evaluable patients. To date, 52 total patients have been injected with NBTXR3 in the study overall, of which 40 have been evaluable.

    Updated data presented at ASCO further support NBTXR3 administration, followed by activation with radiotherapy, as feasible and well-tolerated. Six (6) serious adverse events (SAEs) related to NBTXR3 were observed across five (5) patients. A total of ten (10) deaths related to adverse events were reported. Four (4) deaths related to radiotherapy were observed, along with one (1) death from sepsis that was investigator-assessed as possibly related to NBTXR3, radiotherapy, and cancer.

    At a median follow up of 8.1 months, evaluable patients demonstrated a high primary tumor ORR of 82.5% and a 62.5% CRR. These results are consistent with those observed in the dose escalation part of the study and suggest durability of efficacy.

    Nanobiotix plans to launch a pivotal phase III global registration trial evaluating NBTXR3 as a single-agent activated by radiotherapy for patients with LA-HNSCC in 2021.

    Priming Immune Response and Immunotherapy Combination Across Oncology

    Abstract #2590: A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

    Abstract #2591: Overcoming Resistance to Anti-PD-1 with Tumor-Agnostic NBTXR3: From Bench to Bedside

    Cancer immunotherapies such as anti-PD-1 have shown promising clinical outcomes over the past two decades and are often used to treat advanced cancers once other therapies have reached the end of their effectiveness. However, across tumor indications, the significant majority of patients (80-85% according to published data) receive only a temporary benefit from anti-PD-1—or no benefit at all—as they either develop resistance to the therapy over time or are non-responsive to treatment altogether.

    Previously reported data from the Company's phase I immunotherapy study in advanced cancers (Study 1100) and its preclinical collaboration with The University of Texas MD Anderson Cancer Center support NBTXR3 activated by radiotherapy as a potential primer of immune response. These data suggest that when combined with anti-PD-1, NBTXR3 could contribute to tumor regression in patients with advanced and metastatic tumors regardless of the patient's prior exposure to anti-PD-1.

    Nanobiotix will provide an update on Study 1100 with additional patients and further follow up prior to the conference (abstract #2590). The Company will also present a compilation of preclinical and clinical data supporting NBTXR3 as a potentially tumor-agnostic, therapeutic combination-agnostic agent that could overcome resistance to immune checkpoint inhibitors and increase response rates across tumor indications (abstract #2591).

    Local Control as a Single-Agent for Patients with Soft Tissue Sarcoma

    Abstract #11544: Long-Term Evaluation of the Novel Radioenhancer NBTXR3 plus Radiotherapy in Patients with Locally Advanced Soft Tissue Sarcoma Treated in the Phase III Act.in.Sarc Trial

    A long-term safety analysis following the Nanobiotix phase II/III pivotal study evaluating NBTXR3 as a single-agent activated by radiotherapy in patients with locally advanced soft tissue sarcoma (STS) did not observe a negative impact on patient quality of life and long-term morbidity. The long-term safety profile of NBTXR3, together with its efficacy data, further supported a favorable benefit-risk ratio for patients with STS. The analysis highlighted potential for future indications, including non-resectable sarcoma, pediatric tumors, and re-irradiation.

    Nanobiotix Investor Event

    Nanobiotix will host a virtual investor event featuring several key opinion leaders, including study investigators, after the ASCO Annual Meeting on Friday, June 11, 2021 at 8 am ET. The discussion will expand on the new immunotherapy results from Study 1100 that will be reported prior to ASCO, providing additional detail and clinical perspective, following the ASCO presentation. Register here.

    ***

    About NBTXR3

    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'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.

    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; and a phase III global registrational study is planned to launch in 2021. 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—the same population being evaluated in the planned phase III study.

    Nanobiotix has also prioritized an Immuno-Oncology development program—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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners 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.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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–NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. 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 preclinical or early clinical result 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.21-0272 on April 7, 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.

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  8. Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, chief executive officer, will present at the UBS Global Healthcare Virtual Conference on Monday, May 24, 2021 at 7:00 am Eastern Time.

    A live webcast of the presentation may be accessed by visiting the events section of the company's website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the company's website.

    About NANOBIOTIX

    Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches…

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, chief executive officer, will present at the UBS Global Healthcare Virtual Conference on Monday, May 24, 2021 at 7:00 am Eastern Time.

    A live webcast of the presentation may be accessed by visiting the events section of the company's website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the company's website.

    About NANOBIOTIX

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France, and has subsidiaries in Cambridge, Massachusetts (United States) as well as France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and completed a successful initial public offering (IPO) on the Nasdaq Global Select Market in New York City in December 2020. The company is one of only 7 dual-listed biotech companies with headquarters in France.

    Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms: 1) applied to oncology; 2) applied to bioavailability and biodistribution; and 3) exploring applications to disorders of the central nervous system. The lion's share of the company's resources are devoted to the development of its lead product candidate–NBTXR3—which was born from 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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

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    • LianBio to collaborate in the development of NBTXR3, and contribute to enrollment in five future global registrational studies across several tumor types and therapeutic combinations including immunotherapy
    • Supports the expansion of global phase III registrational study in head and neck cancer into Greater China, with longer term strategic alignment across multiple tumor indications and therapeutic combinations

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511006169/en/

    NANOBIOTIX (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced a partnership…

    • LianBio to collaborate in the development of NBTXR3, and contribute to enrollment in five future global registrational studies across several tumor types and therapeutic combinations including immunotherapy
    • Supports the expansion of global phase III registrational study in head and neck cancer into Greater China, with longer term strategic alignment across multiple tumor indications and therapeutic combinations

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210511006169/en/

    NANOBIOTIX (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced a partnership with LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and major Asian markets, to develop and commercialize Nanobiotix lead product candidate NBTXR3, a potential first-in-class radioenhancer, in Greater China (mainland China, Hong Kong, Taiwan, and Macau), South Korea, Singapore and Thailand.

    Shanghai and Princeton-based LianBio was founded by Perceptive Advisors with an innovative partnership model to develop and commercialize therapeutics in China and other Asian markets. LianBio's cross-border development and commercialization expertise includes strong capabilities in oncology and NBTXR3 is the third investigational cancer treatment in the company's portfolio. Given the global high unmet need in locally advanced and metastatic cancers, along with data supporting the potential of NBTXR3 across solid and metastatic tumor types, Nanobiotix continues to leverage strategic relationships with world class collaborators to expand and accelerate its pipeline while prioritizing Company resources to support development in head and neck cancer and immunotherapy.

    "Discovery of practice-changing therapeutics for major diseases through a physics-based approach, with the support of people committed to making a difference for humanity, is our mission at Nanobiotix. We have long believed that NBTXR3 will significantly improve treatment outcomes for patients with any solid or metastatic tumor, and we are grateful that a partner with the talent and capability of LianBio has agreed to walk with us in our journey. Cancer is a disease that knows no borders and bringing our innovation to patients in Greater China with speed and determination is an absolute necessity," said Nanobiotix CEO and co-founder Laurent Levy.

    "We purpose-built LianBio with a next-generation licensing model that enables us to meaningfully contribute to our partners' global development initiatives in order to accelerate the availability of transformative therapeutics for patients throughout Asia," said Konstantin Poukalov, Executive Chairman of LianBio and Managing Director of Perceptive Advisors. "We believe NBTXR3 has a highly targeted nature and broadly applicable mechanism of action and thus has the potential to change radiotherapy and immuno-oncology treatment paradigms by addressing key limitations of current standards of care."

    "The NBTXR3 therapeutic approach offers a promising avenue to address the significant burden of disease across multiple tumor types," said Debra Yu, M.D., President and Chief Business Officer, LianBio. "Our partnership will provide Nanobiotix with access to LianBio's regional expertise and is designed to enable Nanobiotix to reach the growing number of cancer patients in China and other Asian markets who are in need of improved treatment options."

    Under the terms of the agreement, LianBio will obtain exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore, and Thailand. Nanobiotix will receive a $20 million upfront payment and is entitled to receive up to an aggregate of $220 million in potential contingent, development and commercialization milestone payments. Nanobiotix will also be eligible to receive tiered, low double-digit royalties based on net sales of NBTXR3 in the licensed territories. LianBio will participate in the Nanobiotix global phase III registrational study evaluating NBTXR3 for patients with locally advanced head and neck squamous cell carcinoma (HNSCC; head and neck cancer) by enrolling 100 patients in China in the study. In addition to the phase III head and neck cancer study, LianBio has committed to enroll patients in four additional registrational studies conducted by Nanobiotix across indications and therapeutic combinations potentially including immunotherapy. LianBio will fund all development and commercialization expenses in the collaboration territory, and Nanobiotix will continue to fund all development and commercialization expenses in all other geographies.

    About NBTXR3

    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'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.

    NBTXR3 is being evaluated primarily in locally advanced head and neck squamous cell carcinoma (HNSCC). The company-sponsored phase I dose escalation and dose expansion study has produced consistently favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch in 2021. 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—the same population being evaluated in the planned phase III study.

    Nanobiotix has also prioritized an Immuno-Oncology development program—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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 The University of Texas MD Anderson Cancer Center entered into a broad, comprehensive clinical research collaboration with Nanobiotix to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

    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—NBTXR3—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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter.

    About LianBio:

    LianBio's mission is to catalyze the development and accelerate availability of paradigm-shifting medicines to patients in China and major Asian markets through partnerships that provide access to the best science-driven therapeutic discoveries. LianBio collaborates with world-class partners across a diverse array of therapeutic and geographic areas to build out a pipeline based on disease relevance and the ability to impact patients with transformative mechanisms and precision-based therapeutics. For more information, please visit www.lianbio.com.

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 studies and their potential implications and the development and commercialization of NBTXR3 in the Asian markets under the agreement with LianBio. 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 clinical trials may not generate favorable data notwithstanding positive preclinical result 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 Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des marchés financiers) under number D.21-0272 on April 7, 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.

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    • Expanded clinical data set supporting tumor agnostic potential of NBTXR3 in presentation of first results in rectal cancer at ASCO-GI 2021
    • Initiated new combination study evaluating NBTXR3 activated by radiation in combination with chemotherapy in esophageal cancer and reported new preclinical data in immunotherapy at AACR RSM 2021, providing further support for radioenhancer NBTXR3 as a therapeutic combination-agnostic that could prime adaptive immune response for local and systemic control
    • New collaboration agreement signed by subsidiary Curadigm with Sanofi evaluating novel Nanoprimer technology in gene therapy
    • Cash, cash equivalents, and short-term investments were €107.1 million at March 31, 2021, continuing to support robust development
    • Expanded clinical data set supporting tumor agnostic potential of NBTXR3 in presentation of first results in rectal cancer at ASCO-GI 2021
    • Initiated new combination study evaluating NBTXR3 activated by radiation in combination with chemotherapy in esophageal cancer and reported new preclinical data in immunotherapy at AACR RSM 2021, providing further support for radioenhancer NBTXR3 as a therapeutic combination-agnostic that could prime adaptive immune response for local and systemic control
    • New collaboration agreement signed by subsidiary Curadigm with Sanofi evaluating novel Nanoprimer technology in gene therapy
    • Cash, cash equivalents, and short-term investments were €107.1 million at March 31, 2021, continuing to support robust development plans into the second quarter of 2023

    Regulatory News:

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced operational progress and cash position for the first quarter of 2021.

    "The first quarter of this year saw further progress in development for Nanobiotix," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "We continue to generate data reinforcing our vision for NBTXR3 as a first-in-class radioenhancer that could have a significant impact for patients across solid tumor types and therapeutic combinations. We are also encouraged that Sanofi has seen the potential of Curadigm's Nanoprimer and look forward to a successful collaboration between the two companies in gene therapy."

    Financial Updates Supporting Nanobiotix Development and Corporate Plans

    Cash, cash equivalents, and short-term investments were €107.1 million at March 31, 2021, supporting robust development plans into the second quarter of 2023, compared to €28m as of March 31st, 2020..

    Following the decision to conclude a License and Collaboration agreement with PharmaEngine, Inc., the Company did not generate any revenue during the first quarter of 2021. This compares to €24k for the first quarter of 2020, which resulted from cross-charges associated with the collaboration.

    Clinical Activities and Achievements Advancing Solid Tumor-Agnostic and Combination-Agnostic Potential of NBTXR3

    • Preclinical data, developed in collaboration with the University of Texas MD Anderson Cancer Center (MD Anderson), further suggesting that NBTXR3 could prime adaptive immune response and combine with several immune checkpoint inhibitors was presented at the first American Association of Cancer Research (AACR) Virtual Special Conference on Radiation Science and Medicine in March. This data demonstrated that a combo therapy including NBTXR3, anti-PD-1, anti-TIGIT, and anti-LAG3 augmented anti-tumor response in both irradiated and unirradiated tumors, improving local and distant tumor control and increasing survival rate. The survivor mice were immune to re-injections of tumor cells, maintained significantly higher percentages of memory immune cells and stronger anti-tumor immune activities than control.
    • First clinical results in rectal cancer including recommended phase II dose from the complete phase Ib part of a phase Ib/II study evaluating NBTXR3 activated by radiation therapy with concurrent chemotherapy were presented in January at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI 2021). The data showed that the intra-tumoral injection of NBTXR3 was feasible and well tolerated at all dose levels. More than 70% of patients showed objective tumor response and approximately 90% of patients underwent total mesorectal excision (surgery), and 17.6% achieved pathological complete response. In addition, 50% of the patients receiving surgery had good tumor regression. PharmaEngine, Inc. will implement the termination and wind-down of the phase II part of this clinical study pursuant to the agreement regarding the conclusion of this collaboration.
    • First patient injected in esophageal cancer, a new indication for NBTXR3, in a phase I study evaluating NBTXR3 activated by radiation therapy with concurrent chemotherapy (Study 2020-0122) in January. The trial is being conducted with MD Anderson as part of an ongoing clinical collaboration.

    Corporate Activities and Achievements Expanding Value Creation Opportunities for Nanobiotix

    • Collaboration agreement between Sanofi and Nanobiotix subsidiary, Curadigm, in January. Pursuant to Sanofi's selection of a project involving Curadigm's Nanoprimer technology as a promising option to significantly improve gene therapy development, Curadigm entered into a one-year agreement with the pharmaceutical company inclusive of direct funding and scientific exchanges. The goal of the project is to establish proof-of concept for the Nanoprimer as a combination product that could improve treatment outcomes for gene therapy product candidates.
    • Retention of intellectual property rights for NBTXR3 in the Asia-Pacific region in March 2021 pursuant to a mutual agreement with PharmaEngine, Inc. to conclude the collaboration entered into in August 2012.

    Upcoming Corporate and Clinical Events in the Second Quarter of 2021

    • May 24th: UBS Global Healthcare conference
    • June 1st: Jefferies Healthcare Conference
    • June 4th: American Society of Clinical Oncology (ASCO) congress 2021
    • June 11th: Virtual KOL Event Review Potential Therapeutic Potential of NBTXR3 in Combination with Check Point Inhibitors for Patients with Advanced Cancers

    Updated Financial Agenda

    • July 20th: Second Quarter Corporate Update and Financial Update
    • September 8: Half Year Corporate Update and Financial Update
    • October 20th: Third Quarter Corporate Update and Financial Update

    About NBTXR3

    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'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.

    NBTXR3 is being evaluated primarily in locally advanced head and neck squamous cell carcinoma (HNSCC). The company-sponsored phase I dose escalation and dose expansion study has produced consistently favorable safety data and early signs of efficacy; and a phase III global registration is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted the 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—the same population being evaluated in the planned phase III.

    Nanobiotix has also prioritized a company-sponsored Immuno-Oncology development program—a 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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration with strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 The University of Texas MD Anderson Cancer Center engaged in a broad, comprehensive clinical research collaboration with Nanobiotix to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France and Cambridge, Massachusetts (United States). The company also has subsidiaries in France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and completed a successful initial public offering (IPO) on the Nasdaq Global Select Market in New York City in December 2020. The company is one of only 7 dual-listed biotech companies with headquarters in France.

    Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms: 1) applied to oncology; 2) applied to bioavailability and biodistribution; and 3) applied to disorders of the central nervous system. The lion's share of the company's resources are devoted to the development of its lead product candidate–NBTXR3—which was born from 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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 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 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 on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 7, 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.

    First quarter 2021 Revenue:

    In K€

     

    Q1 2021

    Q1 2020

    Revenues

    0

    23.5

     

     

     

    Of which services

    0

    23.5

     

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    • New data with additional patients and further follow up from Study 1100, evaluating lead product candidate NBTXR3 in combination with anti-PD-1 in head and neck cancer, lung metastasis and/or liver metastasis
    • New data with additional patients and further follow up on safety and response rate from Study 102 dose expansion, evaluating NBTXR3 as a single agent activated by radiotherapy in head and neck cancer
    • Long term safety data from complete European phase II/III registration study, Act.In.Sarc, evaluating NBTXR3 as a single agent activated by radiotherapy in soft tissue sarcoma
    • "From bench-to-bedside" compilation data encompassing the journey of NBTXR3 from preclinical investigation to clinical evaluation of NBTXR3 as a potentially tumor-agnostic…
    • New data with additional patients and further follow up from Study 1100, evaluating lead product candidate NBTXR3 in combination with anti-PD-1 in head and neck cancer, lung metastasis and/or liver metastasis
    • New data with additional patients and further follow up on safety and response rate from Study 102 dose expansion, evaluating NBTXR3 as a single agent activated by radiotherapy in head and neck cancer
    • Long term safety data from complete European phase II/III registration study, Act.In.Sarc, evaluating NBTXR3 as a single agent activated by radiotherapy in soft tissue sarcoma
    • "From bench-to-bedside" compilation data encompassing the journey of NBTXR3 from preclinical investigation to clinical evaluation of NBTXR3 as a potentially tumor-agnostic radioenhancer that could prime adaptive immune response for both local and systemic control
    • Following the ASCO, Nanobiotix will host an investor event on Friday June, 11 at 8am EST, to review immunotherapy results from Study 1100 with several key opinion leaders

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that new data from its oncology pipeline will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8. Four (4) abstracts have been accepted showcasing lead oncology product candidate, potential first-in-class radioenhancer NBTXR3, across tumor types and in combination with anti-PD-1.

    "We look forward to sharing our development progress, particularly from our priority pathways in immunotherapy and head and neck cancer," said Laurent Levy, co-founder and chief executive officer of Nanobiotix. "The data that will be presented at this year's ASCO continue to highlight the potential of NBTXR3 to provide a practice-changing improvement in treatment outcomes for patients with cancer."

    The data to be presented in four posters include:

    Priming Immune Response plus Immunotherapy Combination

    • Abstract #2590: Updated analysis with additional patients and further follow up from Study 1100, a phase I basket study evaluating NBTXR3 activated by radiotherapy in combination with nivolumab or pembrolizumab in locoregional recurrent or recurrent metastatic head and neck squamous cell carcinoma (HNSCC), lung metastasis from any primary tumor and/or liver metastasis from any primary tumor.

    Local Control as a Single-Agent for Patients with Head and Neck Cancer

    • Abstract #6051: Updated analysis with additional patients and further follow up from Study 102, a phase I study evaluating NBTXR3 as a single agent activated by radiotherapy in locally advanced HNSCC. Nanobiotix is planning the launch of a global phase III pivotal trial in this indication in 2021 and has received Fast Track designation from the U.S. Food and Drug Administration for the patient population in the phase III study.

    Local Control as a Single-Agent for Patients with Soft Tissue Sarcoma

    • Abstract #11544: Long-term safety analysis of NBTXR3 from Act.in.Sarc, a European phase II/III registration study evaluating NBTXR3 as a single agent activated by radiotherapy in locally advanced soft tissue sarcoma. NBTXR3 has received a CE marking for this indication under the brand name Hensify®.

    Tumor-Agnostic, Therapeutic Combination-Agnostic Development Potential

    • Abstract #2591: An analysis of compiled data encompassing the journey of NBTXR3 from preclinical investigation to clinical evaluation as a potential first-in-class radioenhancer that could improve local control across solid tumor indications, prime adaptive immune response and combine with immunotherapy.

    Nanobiotix Investor Event

    Nanobiotix will host a virtual investor event featuring several key opinion leaders after the ASCO Annual Meeting on Friday June 11 at 8am EST. The discussion will focus on the new immunotherapy results from Study 1100. Details will be provided closer to the event at www.nanobiotix.com/.

    About NBTXR3

    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'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.

    NBTXR3 is being evaluated primarily in locally advanced head and neck squamous cell carcinoma (HNSCC). The company-sponsored phase I dose escalation and dose expansion study has produced consistently favorable safety data and early signs of efficacy; and a phase III global registration is planned to launch in 2021. In February 2020, the United States Food and Drug Administration granted the 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—the same population being evaluated in the planned phase III.

    Nanobiotix has also prioritized a company-sponsored Immuno-Oncology development program—a 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 lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

    Given the Company's focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy with world class partners to expand development of NBTXR3 in parallel with its priority development pathways. Pursuant to this strategy, in 2019 The University of Texas MD Anderson Cancer Center engaged in a broad, comprehensive clinical research collaboration with Nanobiotix to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

    About NANOBIOTIX

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France and Cambridge, Massachusetts (United States). The company also has subsidiaries in France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and completed a successful initial public offering (IPO) on the Nasdaq Global Select Market in New York City in December 2020. The company is one of only 7 dual-listed biotech companies with headquarters in France.

    Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms: 1) applied to oncology; 2) applied to bioavailability and biodistribution; and 3) applied to disorders of the central nervous system. The lion's share of the company's resources are devoted to the development of its lead product candidate–NBTXR3—which was born from 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®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 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 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 on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 7, 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.

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  9. Availability of Preparatory Documents and Methods for Voting Participation

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX) (Paris:NANO) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that its annual Combined Shareholders Meeting is to be held on April 28, 2021 at 5pm Central European Time (CET), 11am Eastern Standard Time (EST), by way of web conference.

    Given the health measures related to COVID-19, the meeting will be held behind closed doors without the physical presence of shareholders. The meeting can be attended by logging into https://channel.royalcast.com/landingpage/nanobiotix/20210428_1/.

    Availability of Preparatory

    Availability of Preparatory Documents and Methods for Voting Participation

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX) (Paris:NANO) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that its annual Combined Shareholders Meeting is to be held on April 28, 2021 at 5pm Central European Time (CET), 11am Eastern Standard Time (EST), by way of web conference.

    Given the health measures related to COVID-19, the meeting will be held behind closed doors without the physical presence of shareholders. The meeting can be attended by logging into https://channel.royalcast.com/landingpage/nanobiotix/20210428_1/.

    Availability of Preparatory Documents

    All preparatory documents related to the meeting, including postal voting forms and proxy forms, are available upon request via email at investors@nanobiotix.com or via the Company's website at https://www.nanobiotix.com/annual-general-meetings/.

    Methods for Voting and Submission of Written Questions

    Due to its closed-door configuration of the meeting, voting at the meeting will not be possible. As such, Nanobiotix invites shareholders to express their vote to the meeting chairman via postal voting or by proxy. The voting methods are detailed in the convene notice published in the Bulletin des Annonces Légales Obligatoires - BALO on April 12, 2021.

    The meeting configuration will also prevent Nanobiotix from receiving live questions during the meeting. As such, written questions must be sent to investors@nanobiotix.com at least four (4) business days prior to the meeting (i.e., April 22, 2021). The questions must be accompanied by the admission card or the shareholder's certificate of participation either in the registered securities accounts or in the bearer securities accounts held by the intermediary.

    The organization of the Combined Shareholders Meeting is subject to change depending on health measures and/or legal requirements. Shareholders are therefore invited to regularly consult https://www.nanobiotix.com/annual-general-meetings/ to remain up to date with the latest announcements from the Company.

    About NANOBIOTIX: www.nanobiotix.com

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris and also has subsidiaries in France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and completed a successful initial public offering (IPO) on the Nasdaq Global Select Market in New York City in December 2020. The company is one of only 7 dual-listed biotech companies with headquarters in France.

    Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanomedicine platforms: 1) applied to oncology; 2) applied to bioavailability and biodistribution; and 3) applied to disorders of the central nervous system. The lion's share of the company's resources are devoted to the development of its lead product candidate–NBTXR3—which was born from its proprietary oncology platform and is has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 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 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 on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.21-0272 on April 7, 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.

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  10. Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the filing of its universal registration document for the financial year ended December 31, 2020 with the French financial market authority (Autorité des marchés financiers or AMF), as well as its annual report on Form 20-F for the financial year ended December 31, 2020 with the U.S. Securities and Exchange Commission (SEC).

    These documents are available on Nanobiotix's website at https://www.nanobiotix.com/regulated-information/. In addition, the 2020 universal registration document is available on the AMF website (www.amf-france.org) and the…

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced the filing of its universal registration document for the financial year ended December 31, 2020 with the French financial market authority (Autorité des marchés financiers or AMF), as well as its annual report on Form 20-F for the financial year ended December 31, 2020 with the U.S. Securities and Exchange Commission (SEC).

    These documents are available on Nanobiotix's website at https://www.nanobiotix.com/regulated-information/. In addition, the 2020 universal registration document is available on the AMF website (www.amf-france.org) and the 2020 Annual Report on Form 20-F is available on the SEC website (www.sec.gov).

    In particular, the Company's 2020 universal registration document includes its:

    • 2020 annual financial report,
    • Management report including the report on corporate governance
    • Reports from the Company's statutory auditors and information on their fees
    • Required information in relation to the Company's share buyback program

    About NANOBIOTIX: www.nanobiotix.com

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris and also has subsidiaries in France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and completed a successful initial public offering (IPO) on the Nasdaq Global Select Market in New York City in December 2020. The company is one of only 7 dual-listed biotech companies with headquarters in France.

    Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanomedicine platforms: 1) applied to oncology; 2) applied to bioavailability and biodistribution; and 3) applied to disorders of the central nervous system. The lion's share of the company's resources are devoted to the development of its lead product candidate–NBTXR3—which was born from its proprietary oncology platform and is has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 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 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 on April 7, 2021 under "Item 3.D. Risk Factors" and those set forth in the universal registration document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 7, 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.

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    • Substantial progress in priority development pathway in head and neck cancer with clinical registration plan announced, Fast Track designation granted by US Food and Drug Administration, and new data from phase I dose expansion showing 83% objective response rate in primary lesion.
    • First clinical data reported phase I immuno-oncology trial showing conversion of anti-PD-1 non-responders to responders.
    • Extended global capital markets presence with a successful Nasdaq IPO that provided gross proceeds of €93.5 million ($113.3 million).
    • Cash, cash equivalents, and short-term investments were €119.2 million at December 31, 2020, supporting robust development plans into the second quarter of 2023.

    Regulatory News:

    NANOBIOTIX (Paris:NANO…

    • Substantial progress in priority development pathway in head and neck cancer with clinical registration plan announced, Fast Track designation granted by US Food and Drug Administration, and new data from phase I dose expansion showing 83% objective response rate in primary lesion.
    • First clinical data reported phase I immuno-oncology trial showing conversion of anti-PD-1 non-responders to responders.
    • Extended global capital markets presence with a successful Nasdaq IPO that provided gross proceeds of €93.5 million ($113.3 million).
    • Cash, cash equivalents, and short-term investments were €119.2 million at December 31, 2020, supporting robust development plans into the second quarter of 2023.

    Regulatory News:

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported business highlights and financial results for the fiscal year ending December 31, 2020.

    "2020 was a banner year for Nanobiotix, despite challenges posed by COVID-19. Our company achieved several milestones to advance our priority development pathways in head and neck cancer and immuno-oncology; and our successful Nasdaq IPO positioned us to keep our pace in 2021. We look forward to building on our progress to ensure that we deliver the potential benefits of NBTXR3 to patients with deliberate speed," commented Laurent Levy, founder and chairman of the executive board of Nanobiotix.

    2020 Financial Highlights

    • In 2020 total revenue remained stable compared to 2019 and amounted to €2.5M. €0.05M corresponded to the license and collaboration agreement signed with PharmaEngine, a former partner. €1.9M corresponded to the Research Tax Credit (CIR). There we €0.5M in subsidies from the government of France, of which €0.3M was in the context of partial unemployment and €0.2M went to Curadigm SAS from BPI.
    • Research and development expenses decreased from €30.4M in 2019to €24.3M. This decrease is primarily a result of the Company's cost-control efforts relating to R&D subcontracting and consulting fees, as well as a reduction in the number of Group employees assigned to research and development.
    • Selling, general and administrative expenses in 2020 were €14.6M compared to €18.9M in 2019. This decrease is due mainly to the decrease in external costs mainly related to savings due to the COVID-19 pandemic (especially consulting fees) and to the 2019 reclass of the Nasdaq IPO costs.
    • Net loss for the year ended December 31, 2020 was €33.6M, or €1.4 per share (basic and diluted), compared to net loss of €50.9 million, or €2.3 per share for the same period in 2019.
    • Cash, cash equivalents, and short-term investments were €119.2 million on December 31, 2020.

    Clinical activities and achievements advancing NBTXR3 toward global phase III registration trial in head & neck cancer:

    • Clinical registration plan for global phase III head and neck cancer study for elderly patients ineligible for platinum-based chemotherapy announced following feedback from the US Food and Drug Administration (FDA) in January 2020. The FDA also agreed to the chemistry, manufacturing, and controls (CMC) development plan for NBTXR3, to support the future New Drug Application (NDA) for the product candidate and its use in the phase III clinical study.
    • Fast track designation granted by FDA for the patient population in the global phase III head and neck cancer study in February 2020.
    • Preliminary safety and efficacy data from the dose expansion part of phase I study in head and neck cancer reinforcing NBTXR3 as a potential new option for patients presented in October 2020 at the annual meeting of the American Society for Radiation Oncology ("ASTRO"). Among 31 evaluable patients, overall response rate according to RECIST 1.1 was 83.9% of the evaluable patients, 67.7% had achieved a complete response of the injected lesion.

    Clinical activities and achievements advancing I/O combination strategy:

    • First clinical data suggesting NBTXR3 could convert anti-PD-1 non-responders to responders presented at the 35th Anniversary Annual Meeting of The Society for Immunotherapy of Cancer (SITC) in November 2020. Data from company-sponsored study 1100 provided a strong signal that NBTXR3 activated by radiation therapy in combination with pembrolizumab or nivolumab (anti-PD-1 checkpoint inhibitors) could convert anti-PD-1 non-responders to responders. Eight of nine patients treated on study showed tumor regression, including six of seven prior anti-PD-1 non-responders. Four of the anti-PD-1 non-responders had multiple lesions, and three of the four experienced tumor regression in the non-injected local and/or distant lesions. One patient with prior anti-PD-1 resistance experienced delayed tumor regression, suggesting an adaptive immune response aided by NBTXR3 activated by radiation therapy. The early data also demonstrated that administration of NBTXR3 via intra-tumoral injection had been feasible and well tolerated in all patients (head and neck cancer, lung metastasis, and liver metastasis). One patient in the head and neck cancer cohort experienced 4 severe adverse events related to anti-PD-1, of which 2 events were also reported as possibly related to NBTXR3.
    • Positive new preclinical data from two studies suggesting that NBTX3 could have a significant impact in immunotherapy presented at SITC in November 2020. The first study demonstrated that NBTXR3 activated by radiotherapy produced a strong abscopal effect without checkpoint inhibitor combination, stimulated adaptive antitumor immunity and increased TCR repertoire diversity in treated tumors compared to radiation therapy alone. The second study suggested that NBTXR3 plus high dose and low dose radiation (RadScopal™) combined with anti-PD-1 and anti-CTLA-4 could significantly improve the control of both the primary and secondary tumors, extended survival, and reduced lung metastases in an anti-PD-1 resistant lung cancer model. The NBTXR3 combination also promoted anti-tumor response both at molecular and cellular levels and produced long-term anti-tumor memory.

    Clinical activities and achievements advancing clinical collaboration with The University of Texas MD Anderson Cancer Center and expanding the evaluation of NBTXR3:

    • Activation of first study in the collaboration and first patient injected in pancreatic cancer, in May 2020 and September 2020, respectively.
    • Regulatory ‘safe to proceed' granted for a phase I esophageal cancer study in October 2020 and was activated in November 2020. The first patient was subsequently injected in January 2021.
    • Regulatory ‘safe to proceed' granted for two phase II head and neck cancer studies evaluating NBTXR3 in combination with anti-PD-1 in November 2020. The first clinical study (Study 2020-0541) targets patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression, or that are refractory to PD-1 blockade. The second clinical study (Study 2020-0354) targets patients with inoperable locoregional recurrent head and neck squamous cell carcinoma amenable to re-irradiation.
    • Regulatory safe to proceed' granted for a phase I study in lung cancer amenable to re-irradiation in October 2020.

    Corporate activities and achievements enhancing Nanobiotix balance sheet and advancing subsidiary Curadigm:

    • Successful IPO on Nasdaq Global Select Market in December 2020. The offering, including the full exercise of the underwriters' over-allotment option, included a capital increase of 8,395,000 new shares consisting of 6,540,000 ordinary shares in the form of American Depositary Shares (ADSs), each representing one ordinary share, and 1,855,000 ordinary shares placed in certain jurisdictions outside of the United States. The total gross proceeds of the global offering amounted to €93.5 million ($113.3 million), or net proceeds of €82.8 million ($100.4 million) after deducting underwriting commissions and other estimated offering expenses.
    • Successful raise of €20 million in placement of ordinary shares with US and EU investors in July 2020. Nanobiotix placed 3,300,000 new ordinary shares for total gross proceeds of approximately €20.1 million by means of an accelerated bookbuild offering reserved for a specific class of investors in the US and EU.
    • €10M in non-dilutive financing secured in June 2020. Nanobiotix a total of €10 million from HSBC and Bpifrance for in the form of state-guaranteed loans (Prêts Garantis par l'Etat, or PGE in France).
    • Validation of novel nanoprimer technology from subsidiary Curadigm in RNA therapeutics with preclinical data presented at the American Association for Cancer Research (AACR) in June 2020. The data showed that the Curadigm nanoprimer could increase the efficacy of RNA-based therapeutics up to 50% by decreasing rapid liver clearance.

    Expected 2021 Milestones

    • 2021 – Expect first patient injected in phase III trial for elderly head and neck cancer patients (NANORAY-312).
    • Q2 2021 – Presentation of updated phase I dose expansion results in head and neck cancer (Study 102 Expansion)
    • Q2 2021- Updated results with new patients and additional follow up in phase I I/O basket study (Study 1100)
    • H1 2021 – Expect first patient injected in phase II study of NBTXR3 in combination with anti-PD-1 for patients with recurrent/metastatic head and neck cancer
    • H1 2021- Expect first patient injected in phase II study of NBTXR3 in combination with anti-PD-1/L1 for patients with inoperable head and neck cancer
    • H1 2021 – Expect first patient irradiated in phase I lung reirradiation study (first patient injected H2)
    • H2 2021 – Expect launch of post-registration study in soft tissue sarcoma to launch in EU
    • Additional news on other clinical trials and preclinical programs

    Next financial press release: revenue for Q1 2021 on April 30, 2021

    Annual General Meeting will be held on April 28, 2021.

    About NANOBIOTIX:

    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's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

    Incorporated in 2003, Nanobiotix is headquartered in Paris, France and Cambridge, Massachusetts (United States) and is currently staffed by 90 employees (70 in France, 20 in the US). The company also has subsidiaries in France, Spain, and Germany. Nanobiotix has been listed on Euronext: Paris since 2012 and completed a successful initial public offering (IPO) on the Nasdaq Global Select Market in New York City in December 2020. The company is one of only 7 dual-listed biotech companies with headquarters in France.

    Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanomedicine platforms: 1) applied to oncology; 2) applied to bioavailability and biodistribution; and 3) applied to disorders of the central nervous system. The lion's share of the company's resources are devoted to the development of its lead product candidate–NBTXR3—which was born from its proprietary oncology platform and is has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify®.

    For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 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 clinical trials may not generate favorable data notwithstanding positive preclinical result 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 prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

    The consolidated financial statements for the fiscal year ending December 31, 2020 have been approved by the Company's executive board and reviewed by the supervisory board on March 17, 2021. The Company's statutory auditors have completed their audit work on the 2020 financial statements, but they have not issued their audit report yet.

    Consolidated Income Statement:

    In K€

       

    2020

     

     

    2019

     

    Total revenue and other income

       

    2.512

     

     

    2.541

     
     

    Sales

       

    50

     

     

    68

     

    Service

       

    50

     

     

    40

     

    Other sales

       

    -

     

     

    28

     

     

       

     

     

     

     

     

    Other revenue

       

    2.462

     

     

    2.473

     

    Research Tax Credit

       

    1.927

     

     

    2.437

     

    Subsidies

       

    526

     

     

    20

     

    Other

       

    10

     

     

    17

     

     

       

     

     

     

     

     

    Research & Development (R&D) costs 

       

    (24.330)

     

     

    (30.411)

     
     

    Selling, General and Administrative (SG&A) costs

       

    (14.611)

     

     

    (18.909)

     
     

    Operating loss

       

    (36.428)

     

     

    (46.779)

     
     

    Financial loss

       

    2.847

     

     

    (4.133)

     
     

    Income tax

       

    (9)

     

     

    (3)

     
     

    Net loss for the period

       

    (33.590)

     

     

    (50.915)

     

     

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  11. Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that the Company has reached an agreement with PharmaEngine, Inc. ("PharmaEngine") to terminate the License and Collaboration agreement that the Company and PharmaEngine entered into in August 2012.

    As previously disclosed in the Nanobiotix prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020, in November 2020, Nanobiotix notified PharmaEngine of a material breach of the terms of the License and Collaboration agreement. In a letter dated December 1, 2020, PharmaEngine responded to the Company's notification of material…

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that the Company has reached an agreement with PharmaEngine, Inc. ("PharmaEngine") to terminate the License and Collaboration agreement that the Company and PharmaEngine entered into in August 2012.

    As previously disclosed in the Nanobiotix prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020, in November 2020, Nanobiotix notified PharmaEngine of a material breach of the terms of the License and Collaboration agreement. In a letter dated December 1, 2020, PharmaEngine responded to the Company's notification of material breach, denying a material breach of the License and Collaboration agreement, and asserting certain material breaches of that agreement by Nanobiotix. After discussion between the two parties, this agreement to terminate the License and Collaboration agreement represents a full resolution of outstanding disagreements over a number of issues with respect to the development of NBTXR3 in the Asia-Pacific region.

    The License and Collaboration agreement provided PharmaEngine exclusive rights to further the development of NBTXR3 in the Asia-Pacific region. While both Nanobiotix and PharmaEngine believe in the potential of NBTXR3 to improve treatment outcomes for patients with cancer, the parties have had disagreements regarding the optimal strategy for development in the Asia-Pacific region. As such, Nanobiotix and PharmaEngine have mutually agreed to discontinue the collaboration.

    Pursuant to their Termination and Release agreement, Nanobiotix will retain all rights to the development and commercialization of NBTXR3 in the Asia-Pacific region. PharmaEngine is to receive payments, not to exceed $5 million in total, upon the completion of various administrative steps in connection with the winding-up of the collaboration.

    In the future, PharmaEngine will be entitled to receive a payment of $7.5 million upon a second regulatory approval of NBTXR3 in any jurisdiction of the world for any indication, unless the Company announces a collaboration with a new partner for the Asia-Pacific region within 6 months of the effective date of the agreement. If that occurs, PharmaEngine will be entitled to an immediate $2.5 million payment and will be eligible to receive a payment of the remaining $5 million upon such second regulatory approval of an NBTXR3-containing product. The Company has also agreed to pay royalties to PharmaEngine at low-single digit royalty rates with respect to sales of NBTXR3 in the Asia-Pacific region for a 10-year period commencing on the corresponding first date of sales in the region.

    Retention of all rights regarding NBTXR3 will open new near- and long-term possibilities for the Company, and Nanobiotix will evaluate the Asia-Pacific region for potential inclusion in its upcoming global phase III registration trial in head and neck cancer.

    About NBTXR3

    NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles' high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.

    About NANOBIOTIX: www.nanobiotix.com

    Incorporated in 2003, Nanobiotix is a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases.

    The Nanobiotix philosophy is rooted in bringing highly effective, generalized solutions to address unmet medical needs and challenges.

    The Company's first-in-class, proprietary lead technology, NBTXR3, is being evaluated in an expansive global development program both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors.

    Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany.

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 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 challenges associated with developing NBTXR3 in the Asia-Pacific region or identifying a suitable collaboration partner for such development activities, the risk that subsequent studies and clinical trials may not generate favorable data notwithstanding positive preclinical result 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 prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

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  12. Regulatory News:

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, Chief Executive Officer, will speak during a fireside chat at the H.C. Wainwright Global Life Science Conference, being held virtually on March 9-10, 2021.

    Event Details:

    Members of the Nanobiotix management team will also be available to participate in virtual one-on-one meetings with investors who are registered…

    Regulatory News:

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced that Laurent Levy, Chief Executive Officer, will speak during a fireside chat at the H.C. Wainwright Global Life Science Conference, being held virtually on March 9-10, 2021.

    Event Details:

    Members of the Nanobiotix management team will also be available to participate in virtual one-on-one meetings with investors who are registered to attend the conference. The Company's corporate presentation can be downloaded here.

    About NBTXR3

    NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles' high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.

    About NANOBIOTIX: www.nanobiotix.com

    Incorporated in 2003, Nanobiotix is a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases.

    The Nanobiotix philosophy is rooted in bringing highly effective, generalized solutions to address unmet medical needs and challenges.

    The Company's first-in-class, proprietary lead technology, NBTXR3, is being evaluated in an expansive global development program both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors.

    Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 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 challenges associated with developing NBTXR3 in the Asia-Pacific region or identifying a suitable collaboration partner for such development activities, the risk that subsequent studies and clinical trials may not generate favorable data notwithstanding positive preclinical result 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 prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

    View Full Article Hide Full Article
    • Combo therapy including augmented anti-tumor response in both irradiated and unirradiated (abscopal) tumors, improving local and distant tumor control, and increasing survival rate
    • Survivor mice were immune to re-injections of tumor cells, maintained significantly higher percentages of memory immune cells and stronger anti-tumor immune activities than control

    "Evaluation of NBTXR3 as a tumor-agnostic, combo-agnostic product candidate is instrumental to our aim of significantly improving treatment outcomes for millions of patients with cancer. Our early clinical data in several tumor types have support that the physical primary mode of action of NBTXR3 could be universal and potentially benefit patients with any tumor type where radiotherapy

    • Combo therapy including augmented anti-tumor response in both irradiated and unirradiated (abscopal) tumors, improving local and distant tumor control, and increasing survival rate
    • Survivor mice were immune to re-injections of tumor cells, maintained significantly higher percentages of memory immune cells and stronger anti-tumor immune activities than control

    "Evaluation of NBTXR3 as a tumor-agnostic, combo-agnostic product candidate is instrumental to our aim of significantly improving treatment outcomes for millions of patients with cancer. Our early clinical data in several tumor types have support that the physical primary mode of action of NBTXR3 could be universal and potentially benefit patients with any tumor type where radiotherapy is part of the standard of care. Our prior pre-clinical and early data from our ongoing clinical I/O program have provided further support that the biological secondary immune priming effect of NBTXR3 could help patients overcome resistance to anti-PD-1. The data from this preclinical experiment suggest that we may be able to expand the application of NBTXR3 across checkpoint inhibitors, and long-term anti-tumor memory is an outcome we are eager to continue exploring." – Laurent Levy, CEO of Nanobiotix

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced positive new preclinical data investigating first-in-class radioenhancer NBTXR3, which is being evaluated as a tumor-agnostic, combo-agnostic product candidate across several tumor types. The data is being shared via poster presentation at the first American Association of Cancer Research (AACR) Virtual Special Conference on Radiation Science and Medicine, held March 2-3, 2021, by researchers from the University of Texas MD Anderson Cancer Center (MD Anderson).

    PRECLINICAL DATA ON NBTXR3 COMBO

    NBTXR3 is composed of sterile, functionalized, crystalline hafnium oxide nanoparticles that are delivered by intratumoral injection one time prior to radiotherapy (XRT). After activation by XRT, the product candidate has a physical primary mechanism of action through which a higher dose of radiation is delivered within the tumor, enhancing the tumor-killing effect of XRT without increasing the dose in surrounding healthy tissues. The subsequent biological secondary mechanism of action that we are evaluating is the potential activation of several immune pathways upon tumor cell destruction, generating adaptive immune response within the body.

    NBTXR3 is being evaluated in an expansive global development plan both as a single agent activated by XRT and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors. This study examined NBTXR3 activated by XRT in combination with anti-PD-1 along with TIGIT and LAG3 inhibitors in an in vivo anti-PD-1 resistant mouse model (344SQR).

    Key Findings Include:

    • The combination therapy of NBTXR3 + XRT + anti-PD-1 + anti-LAG3 + anti-TIGIT (Combo therapy) significantly promoted the proliferation activity of CD8+ T cells, improved local and distant tumor control, and increased survival rate
    • The anti-tumor efficacy of the Combo therapy was heavily dependent on CD4+ and CD8+ Tcells
    • The survivor mice from the groups treated with the Combo therapy were immune to re-injections of tumor cells
    • The survivor mice maintained significantly higher percentages of memory CD4+ and CD8+ T cells, as well as stronger anti-tumor immune activities than control
    • The Combo therapy augmented anti-tumor response in both irradiated and unirradiated (abscopal) tumors

    POSTER PRESENTATION

    • Title: Integration of anti-TIGIT and anti-LAG3 with NBTXR3-mediated Immunoradiation Therapy Improved Abscopal Effect and Induces Long-term Memory Against Cancer
    • Timing: View on-demand starting at 9:30am EST on March 2, 2021 on Virtual Conference platform
    • Poster Number: PO-040

    ***

    About NBTXR3

    NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles' high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.

    About NANOBIOTIX: www.nanobiotix.com

    Incorporated in 2003, Nanobiotix is a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases.

    The Nanobiotix philosophy is rooted in bringing highly effective, generalized solutions to address unmet medical needs and challenges.

    The Company's first-in-class, proprietary lead technology, NBTXR3, is being evaluated in an expansive global development program both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors.

    Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management'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 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 clinical trials may not generate favorable data notwithstanding positive preclinical result 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 prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

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    • Strong cash position of €119.2M as of December 31, 2020
    • Successful completion of U.S. initial public offering and listing on the Nasdaq Global Select Market
    • Publication of promising clinical results and initiation of several clinical studies

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, announced its revenues for the fourth quarter and full year ended December 31, 2020.

    Full Year 2020 Revenue

     

     

    Twelve Months Ended December 31st

    K€

     

    2020

     

    2019

    Revenues

     

    50

     

    68

     

     

     

     

     

    Of which licenses

     

    -

     

    -

    Of which services

     

    50

     

    68

    Other sales…

    • Strong cash position of €119.2M as of December 31, 2020
    • Successful completion of U.S. initial public offering and listing on the Nasdaq Global Select Market
    • Publication of promising clinical results and initiation of several clinical studies

    Regulatory News:

    NANOBIOTIX (NASDAQ:NBTX), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, announced its revenues for the fourth quarter and full year ended December 31, 2020.

    Full Year 2020 Revenue

     

     

    Twelve Months Ended December 31st

    K€

     

    2020

     

    2019

    Revenues

     

    50

     

    68

     

     

     

     

     

    Of which licenses

     

    -

     

    -

    Of which services

     

    50

     

    68

    Other sales

     

    -

     

    -

    Fourth Quarter 2020 Revenue

    In K€

     

    Q4 2020

     

    Q3 2020

     

    Q2 2020

     

    Q1 2020

    Revenues

     

    -1.51

     

    14.7

     

    13.4

     

    23.5

     

     

     

     

     

     

     

     

     

    Of which licenses

     

    -

     

    -

     

    -

     

    -

    Of which services

     

    -1.5

     

    14.7

     

    13.4

     

    23.5

    Full Year and Fourth Quarter 2020 Financial Results

    Nanobiotix generated annual revenue of approximately €50K, driven primarily by the charging-back of costs incurred on behalf of PharmaEngine in connection with the Company's license and collaboration agreement with PharmaEngine. The absence of revenues in the fourth quarter of 2020 is explained by the issuance of a credit note following an annual adjustment.

    The Company's cash and cash equivalents as of December 31st, 2020 amounted to €119.2M following completion of a successful U.S. initial public offering on the Nasdaq Global Select Market in December 2020 resulting in total gross proceeds of €93.5 million ($113.3 million based on an exchange rate of €1.00=$1.2115). Net proceeds, after deducting underwriting commissions and other offering expenses, were €82.8 million (€100.4 million). Nanobiotix anticipates that its current cash position will be sufficient to fund current operations and planned development activity through the middle of the second quarter of 2023.

    Key Events in Fourth Quarter 2020 and After the Reporting Period

    In October 2020, Nanobiotix announced that the first patient had been injected with NBTXR3 in the Company's phase I trial evaluating NBTXR3 activated by radiation therapy for patients with pancreatic cancer, and that "safe to proceed" notifications had been received from the U.S. Food and Drug Administration (FDA) for two additional trials: (i) a phase I study evaluating NBTXR3 activated by radiation therapy for patients with lung cancer amenable to re-irradiation (Study 2020-0123) and (ii) a phase I study evaluating NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer (Study 2020-0122). These studies are being conducted as part of an ongoing clinical collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson).

    In November 2020, the Company presented positive first clinical data at the 35th Anniversary Annual Meeting of The Society for Immunotherapy of Cancer (SITC) suggesting that NBTXR3 activated by radiation therapy in combination with pembrolizumab or nivolumab (anti-PD-1 checkpoint inhibitors) could transformanti-PD-1 non-responders into responders.

    At SITC, Nanobiotix also published a pre-clinical study revealing that NBTXR3 activated by radiotherapy could under certain circumstances produce a strong abscopal effect without checkpoint inhibitor combination, stimulate adaptive antitumor immunity and increase TCR repertoire diversity in treated tumors compared to radiation therapy alone.

    A second pre-clinical study presented at SITC showed that NBTXR3 plus high dose and low dose radiation (RadScopal™) combined with anti-PD-1 and anti-CTLA-4 could significantly improve control of both the primary and secondary tumors, extend survival, and reduce lung metastases in an anti-PD-1 resistant lung cancer in vivo model—and the treatment combination was observed to promote an anti-tumor response at both molecular and cellular levels and to produce long-term anti-tumor memory.

    Also in November 2020, Nanobiotix announced that the FDA had provided "safe to proceed" notifications for two additional phase II clinical studies with MD Anderson. The first clinical study (Study 2020-0541) targets patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression, or that are refractory to PD-1 blockade. The second clinical study (Study 2020-0354) targets patients with inoperable locoregional recurrent head and neck squamous cell carcinoma amenable to re-irradiation.

    In December 2020, Nanobiotix successfully completed its U.S. initial public offering on the Nasdaq Global Select Market, the operation also included the launch of a placement in Euronext market.

    In January 2021, Nanobiotix announced that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer (Study 2020-0122).

    Also in January 2021, Nanobiotix announced that its wholly-owned subsidiary Curadigm was selected for a new collaboration agreement with Sanofi. Pursuant to Sanofi's selection of a project involving Curadigm's Nanoprimer technology as a promising option to significantly improve gene therapy development, Curadigm entered into a one-year agreement with Sanofi inclusive of direct funding and scientific exchanges. The goal of the project is to establish proof-of-concept for the Nanoprimer as a combination product that could improve treatment outcomes for gene therapy candidates.

    2021 Financial Agenda

    Nanobiotix plans to announce its financial and operating results as follows:

    • March 17, 2021 – 2020 Full Annual Results
    • April 28, 2021 – Annual General Meeting, Paris, France
    • April 30, 2021 – First Quarter 2021 Revenues
    • July 16, 2021 – Second Quarter 2021 Revenues
    • September 3, 2021 – 2021 Half Year Results
    • October 22, 2021 – Third Quarter 2021 Revenues

    About NANOBIOTIX: www.nanobiotix.com

    Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

    The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

    Nanobiotix's novel, potentially first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix's Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

    Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany.

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data, and our relationship with, and the performance of, our collaboration partners, and the funding of our operations. 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 duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

    _________________

    1 Annual revenue regularization resulting in the issuance of a credit note in Q4 2020.

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    • First patient injected in phase I trial evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer
    • This first injection expands evaluation of NBTXR3 to its seventh indication either as a single agent activated by radiotherapy or in combination with other anti-cancer therapies, including immune checkpoint inhibitors and chemotherapy
    • This trial is executed within the scope of an existing clinical collaboration agreement and does not represent incremental costs for the company beyond previously announced financial terms

    Regulatory News:

    "We believe that NBTXR3 could have a positive impact for patients with cancer in any case where radiotherapy is a part of the standard

    • First patient injected in phase I trial evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer
    • This first injection expands evaluation of NBTXR3 to its seventh indication either as a single agent activated by radiotherapy or in combination with other anti-cancer therapies, including immune checkpoint inhibitors and chemotherapy
    • This trial is executed within the scope of an existing clinical collaboration agreement and does not represent incremental costs for the company beyond previously announced financial terms

    Regulatory News:

    "We believe that NBTXR3 could have a positive impact for patients with cancer in any case where radiotherapy is a part of the standard of care. Expansion into esophageal cancer represents not only another step toward achieving our goals, it also highlights the ongoing progress of our clinical collaboration agreement with The University of Texas MD Anderson Cancer Center." – Laurent Levy, CEO of Nanobiotix

    NANOBIOTIX (NASDAQ:NBTX), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform the treatment of cancer, today announced that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer. The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson) as part of an ongoing clinical collaboration.

    Background and Opportunity

    According to the World Health Organization, esophageal cancer is currently the sixth most common cause of cancer death in the world and is estimated to have caused over 508,585 deaths in 2018. The American Cancer Society estimates that in 2020 in the United States, there were approximately 18,440 new esophageal cancer cases diagnosed, and approximately 16,170 deaths due to esophageal cancer. Approximately 20% of patients survive esophageal cancer at least five years after diagnosis.

    Phase I Study of NBTXR3 Activated by Radiotherapy with Concurrent Chemotherapy for Patients with Esophageal Cancer (MD Anderson Study 2020-0122)

    This study is an open-label, single-arm, prospective phase I study consisting of two parts: (i) dose-escalation to determine the RP2D of NBTXR3 activated by radiotherapy with concurrent chemotherapy, and (ii) expansion at RP2D with toxicity monitoring.

    The patient population will include adults (age ≥ 18 years) with stage II-III adenocarcinoma of the esophagus that are treatment-naïve and radiographically non-metastatic at screening. The number of participants enrolled will be determined based on the maximum number required to establish the RP2D of NBTXR3 activated by radiation therapy. Up to 24 subjects will be enrolled, including a maximum of 12 subjects for the dose-escalation part. Twelve additional subjects will be enrolled for the RP2D expansion part. Recruitment is ongoing and the planned enrollment period is 24 months.

    Updates on this trial will be provided as they are made available by MD Anderson.

    ***

    About NANOBIOTIX: www.nanobiotix.com

    Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

    The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

    Nanobiotix's novel, potentially first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix's Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

    Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data, and our relationship with, and the performance of, our collaboration partners, and the funding of our operations. 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 duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

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    • Nanobiotix subsidiary, Curadigm, submitted a research project involving its Nanoprimer technology which was selected for the Sanofi iTech Awards Program, as a highly promising option to significantly improve gene therapy development
    • Following this selection, Curadigm will enter into a one-year agreement with the pharmaceutical company including direct funding and scientific exchanges
    • This selection provides an opportunity for Curadigm's Nanoprimer technology, invented at Nanobiotix, to establish proof of concept as a combination product that could expand the benefits of gene therapy and improve treatment outcomes for patients

    "The continued advancement of Curadigm is a promising part of the expansion of nanotechnology applications invented

    • Nanobiotix subsidiary, Curadigm, submitted a research project involving its Nanoprimer technology which was selected for the Sanofi iTech Awards Program, as a highly promising option to significantly improve gene therapy development
    • Following this selection, Curadigm will enter into a one-year agreement with the pharmaceutical company including direct funding and scientific exchanges
    • This selection provides an opportunity for Curadigm's Nanoprimer technology, invented at Nanobiotix, to establish proof of concept as a combination product that could expand the benefits of gene therapy and improve treatment outcomes for patients

    "The continued advancement of Curadigm is a promising part of the expansion of nanotechnology applications invented by Nanobiotix. We are pleased that Sanofi has recognized the potential of Curadigm's Nanoprimer to improve the efficacy of product candidates in their gene therapy pipeline. As our team at Nanobiotix remains focused on the development of NBTXR3 across oncology, the stand-alone team at Curadigm will leverage this partnership, while exploring other future partnerships, to accelerate development and expand opportunities to improve treatment outcomes for patients." – Laurent Levy, CEO of Nanobiotix

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform cancer treatment, today announced a new collaboration agreement secured by its wholly-owned subsidiary, Curadigm.

    Pursuant to the selection of a project involving Curadigm's Nanoprimer technology as a promising option to significantly improve gene therapy development, Curadigm will enter into a one-year agreement with the pharmaceutical company inclusive of direct funding and scientific exchanges. The goal of the project is to establish proof-of-concept for the Nanoprimer as a combination product that could improve treatment outcomes for gene therapy product candidates.

    Many promising nucleic acid-based therapeutics administered intravenously are limited in their efficacy due to rapid clearance in the liver, which prevents these therapies from reaching the necessary accumulation in target tissues to generate their intended outcomes. Additionally, accumulation in the liver, rather than in the target tissues, can lead to dose-limiting hepatic toxicity.

    The Nanoprimer is proprietary technology invented at Nanobiotix and licensed to Curadigm for development and commercialization. The Nanoprimer is designed to precisely and temporarily occupy therapeutic clearance pathways in the liver. Delivered intravenously, immediately prior to the recommended therapy, the technology acts to prevent rapid clearance—thereby increasing bioavailability and subsequent accumulation of therapeutics in the targeted tissues.

    Given that the Nanoprimer is a combination product candidate that does not alter or modify the therapies it is paired with, Nanobiotix expects that the team at Curadigm will continue to seek partnerships across drug classes—particularly with RNA-based therapies. The Company believes that the ongoing expansion of Curadigm's development pipeline could create new pathways for the significant improvement of treatment outcomes for patients around the world.

    ***

    About CURADIGM: www.curadigm.com

    Curadigm, a Nanobiotix SA subsidiary, is an early-stage nanotechnology company dedicated to improving outcomes for patients by shifting the therapeutic delivery paradigm. Curadigm's Nanoprimer platform is designed to increase drug bioavailability while decreasing unintended off-target effects, specifically liver toxicity. The platform can be used with most intravenous (IV) therapeutics across multiple drug classes. Curadigm is dedicated to advancing therapeutic development based on our deep understanding of how drugs interact with the body, to impact both known and novel drugs across multiple clinical indications.

    About NANOBIOTIX: www.nanobiotix.com

    Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

    The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

    Nanobiotix's novel, potentially first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix's Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

    Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany.

    About Sanofi: www.sanofi.com

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life.

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of Curadigm's development program, the prospects of Curadigm's collaboration with Sanofi, the timing of proof-of-concept data, the potential of Curadigm's platform to achieve clinical and commercial success, and Curadigm's relationship with, and the performance of, its collaboration partners. 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 duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

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    • Positive first results from the complete dose-finding part of a phase Ib/II study of tumor-agnostic NBTXR3 (PEP503) activated by radiotherapy with concurrent chemotherapy for patients with rectal cancer show that intratumoral injection of the product candidate was feasible and it was well tolerated at all dose levels
    • An injection procedure-related dose-limiting toxicity of urinary tract infection was observed in the study, however there were no observed adverse events or severe adverse events associated with NBTXR3
    • More than 70% of patients showed objective tumor response after concurrent chemoradiation
    • Approximately 90% of patients underwent total mesorectal excision (surgery), and 17.6% achieved pathological complete response
    • 50%
    • Positive first results from the complete dose-finding part of a phase Ib/II study of tumor-agnostic NBTXR3 (PEP503) activated by radiotherapy with concurrent chemotherapy for patients with rectal cancer show that intratumoral injection of the product candidate was feasible and it was well tolerated at all dose levels
    • An injection procedure-related dose-limiting toxicity of urinary tract infection was observed in the study, however there were no observed adverse events or severe adverse events associated with NBTXR3
    • More than 70% of patients showed objective tumor response after concurrent chemoradiation
    • Approximately 90% of patients underwent total mesorectal excision (surgery), and 17.6% achieved pathological complete response
    • 50% of the patients receiving surgery had good tumor regression (tumor regression grade 0 or 1)

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (NASDAQ:NBTX), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform cancer treatment, today announced positive first results from the complete phase Ib part of a phase Ib/II study evaluating NBTXR3 (PEP503) activated by radiotherapy with concurrent chemotherapy. This study is sponsored and administered by PharmaEngine, Inc. in Taiwan pursuant to a License and Collaboration agreement with the Company. The data were presented at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI 2021).

    A NEW RADIOENHANCER, PEP503 (NBXTR3), IN COMBINATION WITH CONCURRENT CHEMORDIATION IN LOCALLY ADVANCED OR UNRESECTABLE RECTAL CANCER: THE DOSE-FINDING PART OF A PHASE IB/II TRIAL

    Authors: Jaw-Yuan Wang, Ching-Wen Huang, Ming-Yii Huang, Huang-Ming Hu, Wen-Hung Hsu, Hsiang-Yao Shih, Chiao-Yun Chen, Chou-Pin Chen, Jeffrey Yung-Chuan Chao, You-Hsin Chiu

    Abstract Number: 66

    Background

    Radiotherapy, chemotherapy and surgery are elements of the standard of care for patients with rectal cancer. Concurrent chemoradiation (CCRT) followed by surgery, if possible, is the recommended option for patients with resectable (surgically removable) T3 to T4 tumors, or who have locally unresectable or inoperable disease. Better response to CCRT, prior to surgery, may be associated with better long-term treatment outcomes.

    The potential efficacy of tumor-agnostic NBTXR3 in increasing tumor shrinkage—as observed in phase I head and neck cancer, and phase I liver cancer studies—may result in tumor downstaging and lead to an improvement in surgical outcomes.

    Study Design

    The complete dose-finding part of this phase Ib/II study evaluated the safety, feasibility and recommended phase II dose of NBTXR3 for patients with locally advanced (T3 to T4) or unresectable rectal cancer. The study enrolled 20 patients: with seven, four, three, and six patients at the 5%, 10%, 15%, and 22% dose levels, respectively.

    Topline Results

    Intratumoral injection of NBTXR3 with CCRT was feasible and the product candidate was well tolerated at all dose levels, and no adverse events (AEs) or serious adverse events (SAEs) associated with NBTXR3 were observed in the study. One dose-limiting toxicity associated with the injection procedure was observed (urinary tract infection). The most frequently reported AEs were diarrhea (approximately 45%), leukopenia (approximately 40%), and dermatitis (approximately 25%), however all were grade one or grade two.

    More than 70% of patients in the study showed objective tumor response after CCRT. Around 90% of patients underwent total mesorectal excision (surgery); and 17.6% achieved pathological complete response (pCR). 50% of patients receiving surgery in the study had good tumor regression (tumor regression grade 0 or 1 according to modified Ryan scheme).

    The RP2D has been defined as 22% of tumor volume and the extension phase II is ongoing in Taiwan.

    ***

    About NBTXR3

    NBTXR3 is a novel, potentially first-in-class product candidate designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

    About NANOBIOTIX: www.nanobiotix.com

    Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

    The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

    Nanobiotix's novel, potentially first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix's Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

    Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany.

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data, our relationship with, and the performance of, our collaboration partners, and the sufficiency of cash to fund operations. 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 duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

    View Full Article Hide Full Article
    • Nanobiotix will use a portion of the proceeds from the its IPO to launch its global phase III registration study in head and neck cancer in the United States in 2021
    • Following previously reported preliminary data regarding the ability of NBTXR3 to help transform anti-PD-1 non-responders into responders, the Company will provide the next update on its immuno-oncology phase I basket study evaluating NBTXR3 in combination with anti-PD-1 checkpoint inhibitors in the second quarter of 2021
    • The Company's expansive global development plan for NBTXR3, both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies, will continue as planned

    "Following the successful closing of our initial public offering on

    • Nanobiotix will use a portion of the proceeds from the its IPO to launch its global phase III registration study in head and neck cancer in the United States in 2021
    • Following previously reported preliminary data regarding the ability of NBTXR3 to help transform anti-PD-1 non-responders into responders, the Company will provide the next update on its immuno-oncology phase I basket study evaluating NBTXR3 in combination with anti-PD-1 checkpoint inhibitors in the second quarter of 2021
    • The Company's expansive global development plan for NBTXR3, both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies, will continue as planned

    "Following the successful closing of our initial public offering on Nasdaq in December 2020, Nanobiotix is well positioned to continue global development of NBTXR3 as planned. Despite the challenges presented in 2020, our team achieved significant milestones to advance development of our tumor-agnostic lead product candidate across several indications—both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies. In 2021, we intend to continue advancing our priority head and neck cancer pathway, and to generate further evidence that NBTXR3 could improve immunotherapy patient outcomes by increasing the proportion of patients that respond to immune checkpoint inhibitors. We will also continue to lay the foundation, to expand our development plan and achieve our mission of offering the potential benefits of NBTXR3 to millions of patients around the world." – Laurent Levy, CEO of Nanobiotix

    NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform cancer treatment by increasing the efficacy of radiotherapy and increasing the proportion of patients that respond to immune checkpoint inhibitors, today announced its global development plan for 2021 and beyond.

    Radiotherapy, also called radiation therapy, involves the use of X-rays or other high-energy particles or rays to kill cancer cells in tumors. It is among the most common cancer treatments, both as a standalone therapy and in combination with surgery, chemotherapy or biological therapies. In developed countries with access to radiotherapy, approximately 60% of all cancer patients will receive radiotherapy at least once, either alone or as a part of a more complex treatment protocol. Nevertheless, many of these patients still die from the progression of their cancer because, among other reasons, they are not able to receive a high enough radiation dose to completely destroy their tumor without resulting in an unacceptable level of damage to surrounding healthy tissues.

    The pioneering approach from Nanobiotix uses nanophysics to bring a physical mode of action to destroy cancer cells. Unlike traditional chemotherapies or biologics, NBTXR3 has a broadly applicable mechanism of action that has the potential to be used in the treatment of all solid tumor types in conjunction with radiotherapy and other anti-cancer products.

    The Company believes that NBTXR3's mode of action could improve outcomes for patient populations across all solid tumors that may be treated with radiotherapy. These patient populations represent a significant market opportunity for NBTXR3. Moreover, the Company believes that NBTXR3 could bring new opportunities to patients with cancers that cannot currently be treated with radiotherapy because of the radiosensitivity, or other characteristics, of the tissues near the tumor.

    Following the successful closing of an initial public offering (IPO) on the Nasdaq stock exchange in the fourth quarter of 2020, the Company's strategic long-term goals aim to: (i) complete the development of, and satisfy applicable European Union (EU) and United States (US) regulatory requirements for, NBTXR3 for the treatment of locally advanced head and neck cancers; (ii) establish NBTXR3 as a complementary product to immune checkpoint inhibitors; (iii) complete the post-approval study for NBTXR3 for the treatment of locally advanced soft tissue sarcoma (STS) in the EU; (iv) expand the opportunity for NBTXR3 as a treatment for solid tumor indications; and (v) build an effective clinical development program and establish a global commercial infrastructure for NBTXR3.

    Development of NBTXR3 as a tumor-agnostic product, both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies, is expected to proceed as follows:

    STUDY

    STATUS

    ANTICIPATED NEXT STEPS

    NBTXR3 Activated by Radiotherapy Alone

    Phase III Registration Study of NBTXR3 in Head and Neck Cancer

     

    Nanobiotix Study NANORAY-312

    Fast Track designation received for patient population from US Food and Drug Administration (FDA)

     

    Funding for initiation secured through IPO

     

     

    2021 – Expect first patients injected (FPI)

     

    Futility analysis expected 18 months after FPI; interim analysis expected 24-30 months after FPI

    Phase I Expansion Study of NBTXR3 in Head and Neck Cancer

     

    Nanobiotix Study 102 Expansion

    Dose Expansion – 51 patients injected as of December 31, 2020

     

     

    35 of 44 patients deemed evaluable to date

    2Q 2021 – Expect next results with new evaluable patients and additional follow up on patients treated

     

    Follow up and evaluation ongoing

     

    Phase I Study of NBTXR3 in Liver Cancer

     

    Nanobiotix Study 103

    Complete

     

    Recommended phase II dose (RP2D) established at 42% of tumor volume

    1Q 2021 – Final presentation of phase I results

     

    Next steps to be defined post Study 312 launch

    Post-Registrational Study of NBTXR3 in Soft Tissue Sarcoma

     

    Nanobiotix Study 401

    In preparation

    2H 2021 – Expected study launch in EU

    Phase I Study of NBTXR3 in Pancreatic Cancer

     

    The University of Texas MD Anderson Cancer Center (MD Anderson) Study 2019-1001

    Active

     

    First patient injected

    2021 – Recruitment ongoing

     

    Updates to be provided as they are made available by MD Anderson

    Phase I Study of NBTXR3 in Lung Cancer Amenable to Re-irradiation

     

    MD Anderson Study 2020-0123

    Received FDA ‘Safe to Proceed'

     

    Pending activation

    1H 2021 – Expected study launch

     

    Updates to be provided as they are made available by MD Anderson

    NBTXR3 Activated by Radiotherapy in Combination with Immune Checkpoint Inhibitors

    Phase I Basket Study of NBTXR3 in Combination with Anti-PD-1 for Patients with Head and Neck Cancer, Lung Metastasis and/or Liver Metastasis

     

    Nanobiotix Study 1100

    Positive first results presented at SITC 2020

     

    Recruitment ongoing

    2Q 2021 –Updated results with new patients and additional follow up expected

     

    Phase II Study of NBTXR3 in Combination with Anti-PD-1 for Patients with Recurrent/Metastatic Head and Neck Cancer with Limited PD-L1 Expression

     

    MD Anderson Study 2020-0541

    Received FDA ‘Safe to Proceed'

     

    Pending activation

    1H 2021 – Expected launch and first patient injected

     

    Updates to be provided as they are made available by MD Anderson

    Phase II Study of NBTXR3 in Combination with Anti-PD-1/L1 for Patients with Inoperable Head and Neck Cancer Amenable to Re-irradiation

     

    MD Anderson Study 2020-0354

    Received FDA ‘Safe to Proceed'

     

    Pending activation

    1H 2021 – Expected launch and first patients injected

     

    Updates to be provided as they are made available by MD Anderson

    Phase I Study of NBTXR3 in combination with Anti-CTLA-4 and Anti-PD-1/L1 plus RadScopal in Advanced Solid Tumors with Lung or Liver Metastasis

     

    MD Anderson Study (2020-0618)

    In preparation

    2021 – Expected launch and first patient injected

     

    Updates to be provided as they are made available by MD Anderson

    NBTXR3 Activated by Radiotherapy in Combination with Concurrent Chemotherapy

    Phase I Study of NBTXR3 in Esophageal Cancer

     

    MD Anderson Study 2020-0122

    Active

     

    Not yet recruiting

    1H 2021 – Expect first patient injected

     

    Updates to be provided as they are made available by MD Anderson

    Below is an overview of the Company's most advanced clinical studies.

    Development of NBTXR3 as a Single Agent Activated by Radiotherapy Alone

    Locally Advanced Head and Neck Cancers

    Background and Opportunity:

    Head and neck cancers include cancers of the oral cavity, tongue and oropharynx, a part of the throat. These structures play a critical role in a human's ability to swallow, breathe and speak. The American Cancer Society estimates that in 2020 in the United States, approximately 53,260 patients will be diagnosed with oral or oropharyngeal cancer and approximately 10,750 patients will die from the cancer. According to 2018 estimates by the Global Cancer Observatory, part of the World Health Organization's International Agency for Research on Cancer, around 890,000 patients are diagnosed globally each year with head and neck cancer. The five-year survival rate for patients with oral and oropharyngeal cancer is approximately 65%. These cancers represent a major public health concern.

    Chemotherapy in combination with concomitant radiation is the standard treatment for locally advanced head and neck cancers in both the United States and the EU. However, it is often not an option for elderly patients who are unable to endure the physical strain inherent in chemotherapy treatment. The alternative treatment to chemoradiation is cetuximab in combination with radiotherapy, but it has a limited efficacy in elderly patients. These patients are estimated to account for approximately 25% of patients with head and neck cancers. In data presented at the Multidisciplinary Head and Neck Cancers Symposium 2020, elderly patients treated with radiotherapy alone or radiotherapy in combination with cetuximab had a median PFS of 7.3 months. Elderly patients with locally advanced tumors who receive radiation also generally have short OS rates (median of 12 months following diagnosis, based on our review and sub-group analysis of scientific literature relating to head and neck cancers) and typically experience poor quality of life, as they have limited therapeutic options and a high unmet medical need.

    Phase III Registration Study in Head and Neck Cancer (Nanobiotix Study NANORAY-312)

    In February 2020, Nanobiotix submitted the NANORAY-312 protocol to the FDA for review, a global Phase III clinical study for elderly patients with locally-advanced head and neck cancer who are ineligible for platinum-based (cisplatin) chemotherapy. The Company is in the process of making final protocol refinements in response to FDA feedback and intend to initiate Study NANORAY-312 with a portion of the proceeds from the Company's Nasdaq IPO. Nanobiotix expects the study to launch in the United States in 2021.

    Also in February 2020, the Company received Fast Track designation from the FDA for NBTXR3 in this patient population. Fast Track designation is a process designed to facilitate the development and accelerate the review of treatments for serious conditions and that have the potential to address unmet medical needs. We may also potentially pursue Breakthrough Therapy designation.

    Phase I Dose Expansion Study in Head and Neck Cancer (Nanobiotix Study 102 Expansion)

    The Company is in the process of conducting the dose expansion part of a phase I clinical trial of NBTXR3 activated by intensity-modulated radiation therapy (IMRT) in patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx who are ineligible for cisplatin or intolerant to cetuximab. The expansion cohort utilizes the highest dose level (22%) from the dose escalation portion of Study 102 in order to potentially strengthen preliminary efficacy data from that initial phase. As of December 2020, 51 have been injected in Study 102 Expansion. To date, 35 of the necessary 44 patients have been deemed evaluable. Follow up and evaluation remain ongoing. Nanobiotix presented preliminary efficacy and safety results from Study 102 Expansion in October 2020 at the annual meeting of the American Society for Radiation Oncology (ASTRO).

    Next results will be presented during the International Organization for Medical Physics (IOMP) week in the second quarter of 2021.

    Hepatocellular Carcinoma and Liver Metastasis

    Background and Opportunity:

    According to the World Health Organization, liver cancer is currently the fourth most common cause of cancer death in the world and is estimated to have caused over 781,000 deaths in 2018. The American Cancer Society estimated that in 2020 in the United States, 42,810 people would be diagnosed with liver cancer and 30,160 patients would die of the disease. In Europe, an estimated 47,000 patients die of liver cancer each year. The five-year survival rate for patients with localized liver cancer is approximately 31%; once the cancer has spread to other organs or tissues, this survival rate drops to approximately 3%.

    Two types of liver cancer are hepatocellular carcinoma (HCC), the most common type of liver cancer, and secondary liver cancer, or liver metastasis, which occurs when cancer from another part of the body spreads to the liver. Surgical resection is often not an option for patients with either HCC or liver metastasis. Moreover, because patients suffering from HCC or liver metastases typically have underlying liver dysfunction and concomitant malignancies, local and systemic treatment options are few in number, with significant limitations. Stereotactic body radiation therapy (SBRT)—a high-precision radiation therapy, delivered as high-energy dose fractions—is a prevalent alternative therapy that has been shown to improve outcomes for these patients, as third-party clinical studies have observed a direct correlation between higher doses of radiation and increased survival rates. However, SBRT dosage is limited due to potential toxicity to surrounding tissues and the need to preserve liver function. The Company's ongoing phase I/II clinical study described below evaluated NBTXR3 in patients with liver cancers in need of an alternative treatment, when standard care protocols either cannot be used or do not exist. By increasing the absorption of the administered SBRT dose within the tumor itself, without causing additional damage to surrounding healthy tissues, and causing more effective tumor destruction, Nanobiotix believes NBTXR3 can improve prognoses for this patient population.

    Phase I Study of NBTXR3 for Patients with HCC and Liver Metastasis (Nanobiotix Study 103)

    Nanobiotix has completed its phase I study evaluating the use of NBTXR3 activated by SBRT in liver cancers. The study was conducted at six sites in the EU. The Company recruited 23 patients, divided in two subgroups: patients with primary liver cancer (HCC) and patients with secondary liver cancer (liver metastases).

    The endpoint of the study was determination of the RP2D of NBTXR3 and to assess early signs of anti-tumor activity. Patients received a single intra-lesional injection of NBTXR3, at increasing dose levels, in each case activated by SBRT.

    The final presentation of results from Study 103 will be delivered at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) in the first quarter of 2021.

    Locally Advanced Soft Tissue Sarcoma

    Background and Opportunity:

    Soft tissue sarcomas (STSs) are rare cancers that develop in different types of soft tissues, including muscles, joint structures, fat, nerves and blood vessels. Although STS can develop at any anatomic site, it occurs in the extremities (arms and legs) in approximately 60% of cases. The American Cancer Society estimates that in 2020 in the United States, approximately 13,130 patients will be diagnosed with STS, and approximately 5,350 STS patients will die from this cancer. In the EU, over 23,000 patients are diagnosed with STS each year. The National Cancer Institute estimates that the five-year survival rate for STS patients is approximately 65%. Median overall survival for patients with advanced, metastatic STS is estimated to be 18-19 months. Radiotherapy followed by surgery is part of the typical treatment regimen for STS patients in Europe.

    Achieving local control of the tumor is critical to improving survival rates and reducing the need for limb amputations. Patients with locally advanced STS are high-risk patients and have few therapeutic options capable of achieving local control. Consequently, innovative treatments to improve cancer cell destruction and the feasibility of surgical resection are needed. NBTXR3, when activated by radiotherapy, is designed to enhance the efficacy of radiation both by destroying more tumor cells and rendering the tumor more susceptible to surgical resection, thereby improving patient outcomes.

    Post-Registrational Study of NBTXR3 in Soft Tissue Sarcoma of the Extremities and Trunk Wall (Nanobiotix Study 401)

    In April 2019, Nanobiotix completed the regulatory process for the CE mark of NBTXR3 based on positive results from the Company's phase II/III study evaluating the product candidate for patients with advanced STS of the extremities and trunk, thereby allowing the product to be commercialized in the 27 EU countries under the brand name Hensify ®. Nanobiotix is currently preparing a post-registrational study (Study 401) that will continue evaluating the safety and efficacy of Hensify while providing patients with access to the product. We expect approximately 100 patients to be recruited as part of Study 401, which is expected to launch in Europe in the second half of 2021. Following evaluation of the results from Studies 102 and 312, we intend to continue our strategic review and to consider the optimal approach to the commercialization of Hensify.

    Pancreatic Cancer

    Background and Opportunity:

    Pancreatic cancer is a rare, deadly disease. Worldwide, there were approximately 460,000 new cases in 2018. Given that surgery with R0 resection (i.e., macroscopically complete tumor removal with negative microscopic surgical margins) remains the only hope for long-term survival, clinical studies have investigated various neoadjuvant strategies—wherein patients receive anti-cancer drugs or radiation prior to surgery—to increase the surgery-eligible population while also increasing the R0 resection rate. According to the American Cancer Society, for all stages of pancreatic cancer combined, the one-year relative survival rate is 20%, and the five-year rate is 7%.

    In support of the rationale for neoadjuvant therapy, a retrospective analysis demonstrated a near doubling in OS in pancreatic ductal adenocarcinoma ("PDAC") patients who underwent surgery, which was attributed, at least in part, to the increased proportion of borderline resectable pancreatic cancer ("BRPC") patients who became eligible for surgery as a result of neoadjuvant intervention. Importantly, there are also select cases of locally advanced pancreatic cancer ("LAPC") patients being considered for surgical resection based on their response to therapy. Given the poor prognosis of PDAC, therapeutic regimens able to increase the proportion of BRPC and LAPC patients eligible for surgery could improve survival outcomes in this population with unmet need.

    Phase I Study of NBTXR3 for Patients with Pancreatic Cancer (MD Anderson Study 2019-1001)

    This MD Anderson study is an open-label, single-arm, prospective phase I study consisting of two parts: (i) dose-escalation to determine the RP2D; and (ii) expansion at RP2D.

    In May 2020, we announced that the FDA allowed the clinical study protocol to proceed, and we dosed the first patient in this study during September 2020. Recruitment is expected to remain ongoing throughout 2021 and additional updates will be provided as they are made available by MD Anderson.

    Lung Cancer

    Background and Opportunity:

    According to the World Health Organization, lung cancer is currently the most common cause of cancer death in the world and is estimated to have caused over 1,761,000 deaths in 2018. According to the American Cancer Society, in 2020 it is estimated that there will be approximately 228,000 new cases of lung cancer diagnosed in the United States. It is estimated that in the United States there will be approximately 135,720 deaths from lung cancer in 2020. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses. The five-year relative survival rate for NSCLC at all stages was 24%.

    Phase I Study of NBTXR3 for patients with Lung Cancer Amenable to Re-irradiation (MD Anderson Study 2020-0123)

    This MD Anderson study is an open-label, two-cohort, prospective phase I study consisting of two parts: (i) a radiation therapy safety lead-in, and NBTXR3 activated by radiation therapy dose-finding to determine the RP2D, and (ii) expansion at RP2D with toxicity monitoring.

    The patient population will include adults (age ≥ 18) with inoperable, locoregional recurrent ("LRR") non-small cell lung cancer (NSCLC) stage IA to IIIC that are radiographically non-metastatic at screening and have previously received definitive radiation therapy. The number of participants enrolled will be determined based on the maximum number required to establish the RP2D. Cohort 1 will evaluate the safety of intensity-modulated radiation therapy ("IMRT") monotherapy in 10 patients using an approach similar to a 3+3 design. If 45 Gy in 15 fractions is deemed safe, cohort 2 will test that regimen with NBTXR3 activated by IMRT. Alternatively, if 45 Gy in 15 fractions is deemed to have excessive toxicity, a 30 Gy in 10 fractions regimen will be used in combination with NBTXR3 in cohort 2. Up to 24 subjects will be enrolled in cohort 2, including a maximum of 12 subjects for the dose-finding part. Twelve additional subjects will be enrolled for the NBTXR3 RP2D expansion. Study initiation is expected in the first half of 2021, and the planned enrollment period is 36 months.

    The launch of this study has been delayed by logistical constraints associated with the COVID-19 pandemic. Updates will be provided as they are made available by MD Anderson.

    Development NBTXR3 Activated by Radiotherapy in Combination with Immune Checkpoint Inhibitors (Immuno-Oncology Program)

    Background and Opportunity:

    In recent years, significant attention has been focused on the potential of immuno-oncology (I-O) treatments, and in particular, checkpoint inhibitors. Checkpoint inhibitors are a type of immunotherapy that function to block proteins that stop the immune system from attacking cancer cells. In doing so, they enable the T cells to recognize cancer cells that would otherwise be invisible to immune attack. However, many tumors, which are referred to as "cold" tumors, exhibit little or no response to checkpoint inhibition.

    Cancer immunotherapy is becoming a major treatment paradigm for a variety of cancers. Although immunotherapy, especially the use of immune checkpoint inhibitors, has achieved clinical success, most cancer patients present resistance to I-O treatments. In fact, published scientific data shows that only 15%-20% of non-small cell lung cancer patients and 13%-22% of head and neck squamous cell carcinoma patients respond to immune checkpoint inhibitors. We believe that NBTXR3 activated by radiotherapy in combination with immune checkpoint inhibitors has the potential to unlock the potential of I-O treatments by converting checkpoint inhibitor non-responders into responders.

    Our preclinical and early clinical study results suggest that NBTXR3-enhanced radiotherapy may prime the immune response, thereby rendering otherwise cold tumors more prone to recognition by the patient's immune system and therefore more responsive to I-O treatments such as checkpoint inhibitors. This effect is also referred to as causing a "cold" tumor to become "hot."

    Phase I Basket Study of NBTXR3 in Combination with Anti-PD-1 for Patients with Head and Neck Cancer, Lung Metastasis and/or Liver Metastasis (Nanobiotix Study 1100)

    Nanobiotix presented positive first clinical results from Study 1100 at the SITC 35th Annual Meeting in November 2020. Recruitment in the study remains ongoing, and the Company expects updated results with new patients and additional follow-up at the Annual Meeting of the American Society for Clinical Oncology in the second quarter of 2021.

    Phase II Study of NBTXR3 in Combination with Anti-PD-1 for Patients with Recurrent/Metastatic Head and Neck Cancer with Limited PD-L1 Expression (MD Anderson Study Number 2020-0541)

    This MD Anderson study is an open label, two cohort, non-randomized phase II study. The primary objective of the study is to evaluate tumor response of NBTXR3 activated by radiation therapy in combination with pembrolizumab in patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) with limited PD-L1 expression.

    Nanobiotix expects this study to launch and inject the first patient in 2021. Updates will be provided as they are made available by MD Anderson.

    Phase II Study of NBTXR3 in Combination with Anti-PD-1 for Patients with Head and Neck Cancer Amenable to Re-Irradiation (MD Anderson Study Number 2020-0354)

    This MD Anderson study is an open label, two cohort, non-randomized phase II study. The primary objectives of the study are: (i) to estimate progression-free survival (PFS) and the early clinical benefit in patients treated with NBTXR3 activated by SBRT re-irradiation, with concurrent pembrolizumab; (ii) to assess the safety profile and estimate the early clinical benefit of NBTXR3 activated by a reduced dose of IMRT or IMPT re-irradiation with concurrent pembrolizumab.

    Nanobiotix expects this study to launch and inject the first patient in 2021. Updates will be provided as they are made available by MD Anderson.

    Phase I Study of NBTXR3 in Combination with Anti-PD-1 and Anti-CTLA-4 plus RadScopal for Patients with Advanced Solid Tumors and Lung or Liver Metastasis (MD Anderson Study Number 2020-0618)

    This MD Anderson study is currently in the early stages of the regulatory review process. Nanobiotix expects this study to launch and inject the first patient in 2021. Updates will be provided as they are made available by MD Anderson.

    Development of NBTXR3 Activated by Radiotherapy in Combination with Concurrent Chemotherapy

    Esophageal Cancer

    Background and Opportunity:

    According to the World Health Organization, esophageal cancer is currently the sixth most common cause of cancer death in the world and is estimated to have caused over 508,585 deaths in 2018. The American Cancer Society estimates that in 2020 in the United States, there will be approximately 18,440 new esophageal cancer cases diagnosed, and approximately 16,170 deaths due to esophageal cancer. Approximately 20% of patients survive esophageal cancer at least five years after diagnoses.

    Phase I Study of NBTXR3 for Patients with Esophageal Cancer (MD Anderson Study 2020-0122)

    The FDA has indicated that our Phase I clinical study of NBTXR3 with MD Anderson for patients with esophageal cancer may proceed.

    This study is an open-label, single-arm, prospective phase I study consisting of two parts: (i) does-escalation to determine the RP2D of NBTXR3 activated by radiotherapy with concurrent chemotherapy, and (ii) expansion at RP2D with toxicity monitoring.

    The patient population will include adults (age ≥ 18 years) with stage II-III adenocarcinoma of the esophagus that are treatment naïve and radiographically non-metastatic at screening. The number of participants enrolled will be determined based on the maximum number required to establish the RP2D of NBTXR3 activated by radiation therapy. Up to 24 subjects will be enrolled, including a maximum of 12 subjects for the dose-finding part. Twelve additional subjects will be enrolled for the RP2D expansion. Recruitment and first injections are expected to begin in the first half of 2021 and the planned enrollment period is 24 months.

    The launch of this study has been delayed by logistical constraints associated with the COVID-19 pandemic. Updates will be provided as they are made available by MD Anderson.

    PharmaEngine Trials

    Pursuant to a License and Collaboration Agreement with PharmaEngine, Inc., three NBTXR3 clinical trials are currently being run in Asia by PharmaEngine. These trials include a phase III study of NBTXR3 activated by radiotherapy for patients with soft tissue sarcoma, a phase I/II study of NBTXR3 activated by radiotherapy with concurrent chemotherapy for patients with rectal cancer, and a phase I/II study of NBTXR3 activated by radiotherapy with concurrent chemotherapy for patients with head and neck cancer.

    Results from the rectal cancer study will be presented at the 2021 American Society of Clinical Oncology Gastrointestinal Symposium. Further updates will be provided as they are made available by PharmaEngine.

    ***

    About NBTXR3

    NBTXR3 is a novel, potentially first-in-class product candidate designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

    About NANOBIOTIX: www.nanobiotix.com

    Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

    The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

    Nanobiotix's novel, potentially first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix's Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

    Nanobiotix is listed on the regulated market of Euronext in Paris (GREY:NNBXF, Bloomberg: NANO: FP))) and on the Nasdaq Global Select Market (NASDAQ:NBTX). The Company's headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany

    Disclaimer

    This press release contains certain "forward-looking" 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 "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions. These forward-looking statements, which are based on our management's current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data, our relationship with, and the performance of, our collaboration partners, and the sufficiency of cash to fund operations. 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 duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption "Risk Factors" and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.20-010 on May 12, 2020 (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.

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