Date: 2014-11-25
Type of information: Private placement
Company: Nanobiotix (France)
Investors: Capital Ventures International (USA)
Amount: up to $25 million
Funding type: private placement
Planned used: Nanobiotix intends primarily to use the proceeds from the placement for the following purposes: - expansion of the NBTXR3 portfolio by launching a larger Phase I/II studies in Liver (including both HCC and liver Met patient population). New phase I/II on Prostate. The objective in both indication is to target US and EU market - completion of a preclinical package to comply with FDA requirementsNot for release, publication or distribution, directly or indirectly, in the United States, Canada, Australia or Japan - potential development of STS indication in the Unites-States, depending on intermediary European results through a bridge study - preparation of a market access plan for commercialization of NBTXR3 in EU and registration in US - building US capabilities with local recruitments. The company intends to develop new high potential indications in both US and EU, in parallel with the soft tissue sarcoma registration clinical trial and Head and Neck cancer trial already underway in Europe. As previously announced, Nanobiotix is pursuing a standalone development and commercialization strategy for its lead product NBTXR3 in Europe. Today, the Company announces its intention to adopt a similar independent strategy for the development of NBTRXR3 in the United States. The primary indication to bring NBTXR3 to the European market is in soft tissue sarcoma. The global clinical development plan now includes a larger number of therapeutic indications: head and neck cancer, metastatic liver cancer, hepatocellular carcinomas and prostate cancer. Those last two new indications would represent the largest markets to be targeted.
Nanobiotix is increasingly focused on preparing the pivotal phase for its lead product NBTXR3 for patients with soft tissue sarcoma, before registration which is planned for 2016. Beyond this first main value driver, Nanobiotix aims to develop new indications, and also to address new territories, in a broader and more aggressive plan. The recently opened Nanobiotix affiliate in Cambridge will play a key role in the company’s US development plan. Nanobiotix is planning to investigate whether NBTXR3 could be used for local treatment of liver cancers, including different patient population such as hepatocellular carcinoma (HCC) and liver metastases
(arising from colorectal cancer, breast cancer…). The Company plans to initiate the pilot clinical trial in these cancers at the beginning of H2 2015. This trial should include between 24 to 32 patients. The medium term goal is to develop this indication both in Europe and the United States, to establish the value of the product, thanks to the demonstration of the prolongation of patients\' life.
The inclusion of liver metastases in the scope of NBTXR3 would more than double the total potential population that this product could be prescribed to, as more than 300,000 additional patients in the top five European countries, the US and Japan markets could benefit from NBTXR3. If this is the case, this indication would have the biggest potential market for NBTXR3.
The Company is also seeking to use NBTXR3 in patients with high risk prostate cancer with the aim of providing effective tumor control combined with tumor destruction. The benefits for patients would be to avoid local relapse or distant invasion and to preserve genito-urinary function. The planned pilot trial is expected to start in H2 2015. It will involve approximately 24-30 patients with high-risk prostate cancer that has been newly diagnosed, or that results from a first surgical therapeutic failure.
A head and neck cancer clinical study is already underway in Europe. Nanobiotix opened two new sites for this clinical trial in Spain, and will publish interim results in H1 2015. In 2016, depending on the results, Nanobiotix will decide whether to accelerate development and launch a registration trial in the EU and US.
Others: * On November 25, 2014, Nanobiotix, a clinical stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announced the completion of a private placement with Capital Ventures International (“CVI”) of new shares with warrants attached for a total amount of € 10,393,500, which may be supplemented by an amount of up to € 14,059,500 in case of exercise of all the warrants, (ii) CVI’s commitment to purchase an additional tranche of up to € 10 million that the Company may issue in its discretion (subject to any required corporate authorizations) under the terms and conditions described below, (iii) The private placement was carried out in accordance with article L. 411-2 II of the French monetary and financial code, article L. 225-136 of the French commercial code and the 16th and 17th resolutions of Nanobiotix’ general shareholders meeting held on June 18, 2014. A total of 650,000 ordinary shares (the “New Shares”) were issued to CVI in the private placement, representing around 4.85% of the outstanding shares prior to the private placement. In accordance with the 17th resolution of Nanobiotix’ general shareholders meeting held on June 18, 2014, the price of the placement has been set at €15.99 per New Share. This price represents a 15% discount to the volume weighted average price (VWAP) of the last 5 trading days preceding the pricing date. One warrant is attached to each New Share, entitling CVI to subscribe, at any time and in one or more installments until June 30, 2016, for one additional share per warrant, i.e. a maximum of 650,000 additional ordinary shares (the “Additional Shares”) at a price of € 21.63 per share (i.e., 115% of the arithmetic average of the VWAP of the Company\'s shares on each of the five (5) trading days immediately preceding the pricing date). The warrants will be immediately detached (détachés) from the New Shares as from their issuance and will be credited in registered form (nominatif). The Company may require CVI to exercise the warrants if the daily VWAP of the Company\'s ordinary shares shall exceed 150% of the exercise price of the warrants, i.e., € 32.45, for any twenty (20) out of thirty (30) consecutive trading days before the expiration of the warrants. The warrants’ exercise price will be automatically adjusted downwards (but not to be less than 95% of the arithmetic average of the VWAP of the Company\'s shares on each of the five (5) trading days immediately preceding the pricing date) in the event of any subsequent new issue of shares or securities giving access to the capital of the Company on the basis of a price per share lower than the exercise price of the warrants (excluding any options or other incentive shares to employees and executives of the group not to exceed 5% of the capital). Finally, CVI has committed (subject to certain conditions) to purchase a third tranche of up to 10 million € of additional ordinary shares, not to exceed 650,000 shares, if the Company shall decide in its discretion to issue them to CVI in the period from November 25, 2015 to March 31, 2016, at a price equal to 85% of the arithmetic average of the VWAP of the Company\'s shares on each of the five (5) trading days immediately preceding their issue date, but in no event greater than the VWAP of the Ordinary Shares on the trading day immediately preceding the applicable date.
the Company’s new global development plan and (iv) the registration with the French Autorité des marchés financiers (AMF) of the Company’s reference document, which has been updated with the information relating to the Company’s business to date.
Therapeutic area: Cancer - Oncology
