UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2022
Commission File Number: 001-39777
Nanobiotix S.A.
(Translation of registrant's name into English)
60 Rue de Wattignies 75012 Paris, France
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
On November 9, 2022, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated November 9, 2022
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Nanobiotix S.A. | ||
(Registrant) | ||
Date: November 9, 2022 | /s/ Bart Van Rhijn | |
Bart Van Rhijn | ||
Chief Financial Officer | ||
EXHIBIT 99.1
NANOBIOTIX Provides Third Quarter 2022 Operational and Financial Update
PARIS and CAMBRIDGE, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today provided an update on operational progress and announced operational progress and cash position (unaudited) for the third quarter of 2022.
“This quarter saw us continue our prioritized focus on the advancement of NBTXR3 both as a single agent activated by radiotherapy and as a combination therapy with anti-PD-1 for patients with locally advanced head and cancer and recurrent and/or metastatic head and neck cancer, respectively,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. “We believe that the data our clinical development program has produced to date supports the potential of NBTXR3 to improve therapeutic outcomes for patients in need of local control, systemic control, or both. We are eager to share additional Phase 1 data from Study 1100 at the annual SITC congress. In our view, these new data further strengthen our confidence, particularly in the immunostimulatory potential of NBTXR3, and add to our anticipation for the submission of our second registrational Phase 3 protocol to the US FDA for the evaluation of NBTXR3 plus anti-PD-1 in patients with recurrent and/or metastatic head and neck cancer expected in the first quarter of 2023.”
Third Quarter Financial Updates
Nanobiotix reported cash and cash equivalents totaling €53.5 million as of September 30, 2022, compared to €83.9 million as of December 31, 2021.
In October 2022 Nanobiotix executed a final agreement with the European Investment Bank (“EIB”) to re-align approximately €30.7 million in outstanding debt obligations with the Company’s expected development and commercialization timelines. The cash and cash equivalents as of September 30, 2022, combined with the executed EIB debt restructuring and existing equity line, is expected to fund development programs into Q1 2024.
Third Quarter Operational Highlights and Expected Upcoming Milestones
Bolstered NBTXR3 strategic development capability with appointment of global medical experts to the Nanobiotix Scientific Advisory Board
Priority Registration Pathway in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC), Local Control as Single Agent Activated by Radiotherapy (RT):
Priority Pathway in Immunotherapy for Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma (R/M HNSCC), Priming Immune Response in Combination with Anti-PD-1 Treatment:
Expanding NBTXR3 Opportunity, Collaborating with World-Class Partners to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profile:
Conference Call and Webcast
Nanobiotix will host a conference call and live audio webcast on Thursday, November 10, 2022, at 8:00 AM ET / 2:00 PM CET. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial officer, will briefly review the Company’s third quarter results and provide an update on business activities before taking questions from participants.
A live webcast of the call may be accessed by visiting the investors section of the company’s website at www.nanobiotix.com. Participants may register for the call here. They will be able to join the call via dial-in or one-click dial-out. It is recommended to join 10 minutes prior the event start.
Participants are invited to email their questions in advance to investors@nanobiotix.com.
A replay of the webcast will be available shortly after the conclusion of the call 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 is leveraging its proprietary nanoparticle platform, including its lead product candidate, radiotherapy activated NBTXR3, to develop a pipeline of therapeutic options designed to enhance local and systemic control of solid tumors with an initial focus on the treatment of head and neck cancers.
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,” “can,” “could,” “estimate,” “expect,” “intend,” “is designated to,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “objective,” “shall,” “should,” “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. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the risk that subsequent studies and ongoing or future clinical trials may not generate favorable data notwithstanding positive early clinical results; 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; the risk that the EIB may accelerate the loans under finance contract and its amendment upon the occurrence of customary events of default; the risk that Company may not be able to secure additional capital on attractive terms, if at all; the risk that Company may not be able to expand its product pipeline by developing NBTXR3 in additional indications, including in combination with I-O treatment;. Furthermore, many other important risks factors and uncertainties, including those described in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the SEC) on April 8, 2022 under “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 – the AMF) on April 8, 2022, (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 28, 2022, 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.
Contacts
Nanobiotix | |
Communications Department Brandon Owens VP, Communications +1 (617) 852-4835 contact@nanobiotix.com | Investor Relations Department Kate McNeil SVP, Investor Relations +1 (609) 678-7388 investors@nanobiotix.com |
Media Relations | |
FR – Ulysse Communication Pierre-Louis Germain + 33 (0) 6 64 79 97 51 plgermain@ulysse-communication.com | Global – LifeSci Advisors Ligia Vela-Reid +44 (0) 7413825310 Lvela-reid@lifesciadvisors.com |