NhTherAguix
NH TherAguix registration document approved by Autorité des Marchés Financiers as part of planned IPO on Euronext Growth Paris
NhTherAguix
NH TherAguix registration document approved by Autorité des Marchés Financiers as part of planned IPO on Euronext Growth Paris
Grenoble (France), 13 September 2021 NH TherAguix, French biotech company specialized in the development of innovative nanomedicines for the treatment of cancer by radiotherapy, today announces the approval of its registration document by the Autorité des marchés financiers (the “AMF”) under number I.21-048 dated 10 September 2021.
The approval of the document marks the first step in the planned NH TherAguix IPO on the Euronext Growth market in Paris, which remains subject to favourable market conditions and AMF approval of the relevant prospectus.
Géraldine Le Duc, Chief Executive Officer of NH TherAguix, says: “NH TherAguix aims to demonstrate that its nanodrug candidate AGuIX(R) can increase the efficacy of radiotherapy for cancers, while preserving the surrounding healthy tissue. It offers new hope for cancer patients and our ambition is to make AGuIX(R) the new standard of care for certain cancers treatment with radiotherapy. To do this, we have developed AGuIX(R) so that it can be integrated into all current care protocols, without changing patient treatment. The indications that we are primarily targeting include pancreatic cancer, glioblastoma, the most comment brain cancer found in adults, and brain metastases. This planned IPO will allow us to extend the funding of our clinical trials currently in Phase II, with the aim of submitting AGuIX(R) for approval as early as 2025.”
Pushing the current boundaries of radiotherapy In the fight against cancer, radiotherapy is one of the standard care treatments. 60% of patients with cancer are treated with radiotherapy during their care pathway.
However, despite advances in technology and the continuous improvement of equipment, radiotherapy has limitations due to the harmful effects it causes on healthy tissue close to the tumour. These side effects limit the effectiveness of certain treatments and sometimes make radiotherapy unsuitable for certain forms of cancer.
A theranostic1 approach for precision radiotherapy Increasing the x-ray dose differential between the tumour and surrounding healthy tissue is now the most promising way of improving radiotherapy.
Based on this observation, NH TherAguix has developed an innovative theranostic[1] approach in nanomedicine: AGuIX(R). Designed to be able to increase the dose differential between the tumour and healthy tissues and therefore to increase the efficacy of radiation therapy, AGuIX(R) also allows more accurate imaging guidance after targeting the tumour. The combination of these three properties (targeting, imaging and treatment) paves the way for a new generation of precision radiotherapy.
The first “triple action” drug By injecting a single dose, AGuIX(R) works in three complementary ways:
A drug adapted to the patient care pathway Intravenous administration of AGuIX(R) is a key component of its therapeutic effectiveness as it makes it easy to use by healthcare staff. It does not disrupt the treatment pathway, and does not require any specific equipment or training. It is also possible to combine AGuIX(R) with all current and future radiotherapy technologies.
Strong proof of concept The first study in humans was conducted in the Phase 1b trial on brain metastases in 15 patients, NANORAD 1, which first established the absence of toxicity and adverse effects related to AGuIX(R). In addition to the safety parameters, this study demonstrated a clinical benefit with encouraging overall survival rates and confirmed the triple effect of AGuIX(R) after injection (targeting, imaging and treatment). A dosage effect has also been highlighted: the higher the concentration of AGuIX(R) in brain metastases, the lower their size and therefore the better their response to treatment.[3]
Preliminary observations of the ongoing NANORAD 2 Phase 2 trial on brain metastases show tolerance and contrast entirely consistent with the Phase 1 trial results. It also seems that the activity signals of AGuIX(R) already cited, namely a radiosensitization response related to improved control of tumour volume and survival, can be observed here. These very preliminary observations reveal a trend that needs to be confirmed or invalidated based on the existence of the control arm and the statistical strength of the trial if sufficient.
A potential pan-cancer treatment deployed through seven Phase 1 and 2 clinical trials, three of which are already being used The properties of AGuIX(R) show potential for a “pan-cancer” application. The intravenous injection method, combined with the ability of AGuIX(R) to accurately target the tumour, can treat types of cancer that are difficult to access by intratumoral injection. At this stage, all injected tumours have been visible via MRI (49 patients).
Markus Loeffler, NH TherAguix Medical Director, comments: “The results of the Phase 1 study are very encouraging. NH TherAguix has now entered Phase 2 with two clinical trials focusing on radiotherapy for brain metastases, either by whole brain radiotherapy (NANORAD 2), or as a complementary treatment by radiosurgery/sterotactic radiotherapy (NANOBRAINMETS), and also has a Phase 1 trial on advanced cervical cancer (NANOCOL). The launch of other trials in Europe and the United States, in partnership with internationally renowned cancer research institutes, is a very important strategic step for NH TherAguix. “
By the end of 2021, AGuIX(R) technology should be in use in 8 Phase 1 and 2 clinical trials, 3 of which are already being implemented:
*ODD (Orphan Drug Designation): orphan drug status obtained in the United States, allowing for fast track recording in case of conclusive outcomes.
Clinical Development Strategy The clinical development strategy of AGuIX(R) aims to exploit its pan-cancer potential with the objective of recording as quickly as possible primary and orphan cancers such as pancreatic cancer or glioblastoma, for which the therapeutic arsenal is very limited and which represent a significant market opportunity. For these indications, the Company operates in partnership with renowned institutes such as Dana-Farber Cancer Institute at Harvard. The Company is also targeting a broader market, namely the treatment of brain metastases, an indication in which the Company has already acquired results and the potential of which is significant due to its impact, and in which the number of competitors is limited. The Company is also considering the development of AGuIX(R) to treat other indications, and as such is promoting the implementation of clinical trials in the framework of academic collaboration funded by research grants to enable it to collect clinical and scientific data, while preserving its financial resources.
Financial and industrial support In 2019, the company experienced strong growth thanks to the raising of A Series funds amounting to €12.3 million from renowned venture capital funds (BPI Innobio2, Arbevel, Omnes and Supernova). Thanks to this funding, the Company was able to launch its Phase 2 clinical trials and fund the scaling of production of its experimental drug, in partnership with Sanofi, the laboratory that produces the AGuIX(R) nanoparticle.
Availability of registration document Copies of the NH TherAguix Registration Document, approved by the AMF dated 10 September 2021 under number I.21-048, are available free of charge upon request from the Company and can also be consulted on the websites of the AMF (https://www.amf-france.org) and NH TherAguix (https://investir.nhtheraguix.com). The registration document contains a detailed description of NH TherAguix, including its business activity, strategy and financial position, as well as the corresponding risk factors.
Risk Factors The risks associated with the continued successful clinical development of AGuIX(R), and more generally the risk factors to which the Company is exposed, are presented in chapter 3 “Risk Factors” of this Registration Document. The occurrence of one or more of these risks is liable to have a significant adverse impact on the activities, assets, financial position, results or outlook of NH TherAguix, as well as on the market price of the Company’s shares.
Information on the planned stock exchange listing of NH TherAguix can be found on: https://investir.nhtheraguix.com
About the company NH TherAguix (www.nhtheraguix.com)NH TherAguix is a French biotech start-up based in Grenoble and created in 2015 by two co-founding scientists, Prof Olivier Tillement (Scientific advisor of NH TherAguix and Director of the Fennec team, Institute Lumière Matière, University of Lyon 1) and Géraldine Le Duc (CEO of NH TherAguix), after 10 years of preclinical research. The technology of the drug candidate AGuIX(R) is supported by 14 patent families and more than 70 scientific publications. The production of AGuIX(R) is handled by partners such as Sanofi and Carbogen. The team currently consists of 13 people and its board of directors is chaired by Hervé Brailly (Co-founder and current chairman of the supervisory board of Innate Pharma). The Company is expected to roll out 8 Phase 1b and 2 clinical trials by the end of 2021, of which 3 are already being used and 7 have been approved by the regulatory authorities, with a specific focus on neuro-oncology (brain metastases, glioblastoma), pancreatic and lung cancers and advanced cervical cancer.
Contacts:
Disclaimer No communication or information relating to NH TherAguix’s issuance of shares (the “Shares“) may be disseminated to the public in a country in which a registration or approval obligation applies. No action has been taken (or will not be undertaken) in any country other than France in which such steps are required. The issuance or subscription of Shares may be subject to specific legal or regulatory restrictions in certain countries. NH TherAguix assumes no liability for any breach by any person of these restrictions. This press release does not constitute a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the “Prospectus Regulation“). The offering will be open to the public exclusively in France after the AMF has issued its approval in the corresponding prospectus. For EEA Member States other than France (the “Member States“) that have enacted the Prospectus Directive into national law, no action has been or will be undertaken to enable a public share offering that would require a prospectus to be published in any of said Member States. Accordingly, the Shares may and shall only be offered in Member States (i) to qualified investors within the meaning of the Prospectus Regulation or (ii) in accordance with the other exceptions provided for by Article 1(4) of the Prospectus Regulation. For the purposes of this paragraph, the concept of “public offering” in each of the Member States shall be defined as any communication addressed in any form and by any means to persons and presenting sufficient information on the conditions of the offering and the Shares to be offered to enable an investor to decide whether to purchase or subscribe to such Shares. This investment restriction is in addition to other investment restrictions applicable in Member States. This press release and the information contained herein is intended for use only by persons located (x) outside the United Kingdom or (y) in the United Kingdom, who are “qualified investors” (as defined in the Prospectus Regulation which is part of internal law in accordance with the European Union (Withdrawal) Act 2018) and (i) who are “investment professionals” within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Financial Promotion Order“), (ii) who are referred to in Article 49(2) (a) to (d) of the Financial Promotion Order (“high net worth companies, unincorporated associations etc.”) or (iii) are persons to whom an invitation or incentive to participate in an investment activity (within the meaning of Article 21 of the Financial Services and Markets Act 2000) may be legally communicated or transmitted (the persons referred to in paragraphs (y)(i), (y)(ii) and (y)(iii) being jointly referred to as “Qualified Persons“). Any invitation, offer or agreement for the subscription or purchase of financial securities covered by this press release shall be accessible only to Qualified Persons and may only be made by the Qualified Persons. This press release is intended solely for Qualified Persons and may not be used by anyone other than a Qualified Person. This press release does not constitute an offer of securities or any solicitation to buy or subscribe to securities nor a solicitation to sell securities in the United States. The securities which are the subject of this press release are not and will not be registered within the meaning of the U.S. Securities Act of 1933 as amended (the “U.S. Securities Act“) and may not be offered or sold in the United States of America without registration or exemption from the registration requirement pursuant to the U.S. Securities Act. NH TherAguix does not intend to register the offering mentioned in this press release or part of this offering in the United States of America or to carry out any public offering in the United States of America. The distribution of this press release in certain countries may constitute a breach of local laws and regulations. The information contained in this press release does not constitute an offer of securities in the United States of America, Canada, Australia or Japan. This press release may not be published, transmitted or distributed either directly or indirectly in the United States of America, Canada, Australia or Japan. [1] Theranostics: therapeutic approach combined with better diagnosis
[2] Enhanced Permeability Retention effect: nanoparticles tend to accumulate more in the tumour than in healthy tissues, mainly due to 2 biological phenomena: abnormal blood vessel development and inefficiency of lymphatic drainage in cancerous tissues. [3]Targeting brain metastases with ultrasmall theranostic nanoparticles, a first-in-human trial from an MRI perspective. Verry C et al. Science Advances. 2020 Theranostic AGuIX nanoparticles as radiosensitizer: A phase I, dose-escalation study in patients with multiple brain metastases (NANO-RAD trial) Verry C. et al. Radiotherapy & Oncology, 2021 [GLD1]Attention la diapo est en francais . La version anglaise se trouve dans le deck. Regulatory filing PDF file File: NH TherAguix registration document approved by Autorité des Marchés Financiers as part of planned IPO on Euronext Growth Paris |
Language: | English |
Company: | NhTherAguix |
29 chemin du vieux Chêne | |
38240 Meylan | |
France | |
Phone: | 0476041456 |
E-mail: | cruz@nhtheraguix.com |
Internet: | www.nhtheraguix.com |
AMF Category: | Inside information / Issuer activities (acquisitions, sales…) |
EQS News ID: | 1232807 |
End of Announcement | EQS News Service |