ISIN.net news update announces 6 month results:
NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces its half year results for the six months ended 30 June 2015.
Financial highlights:
- Total revenue of circa €1.7m (H1 2014: €1m) includes the pro-rata share of the initial upfront payment from PharmaEngine (€91k), research tax credit (€1.4m) and other subsidies (€149k)
- Increase of R&D costs to €6.1m (H1 2014: €3.3m) to support the acceleration of the clinical development plan, such as the expansion of the pivotal trial on soft tissue sarcoma (Phase II/III), the on-going head and neck cancer Phase I/II and the preparation of new additional clinical trials
- Increase of G&A costs to €2.8m (H1 2014: €1.8m) mainly dedicated to Nanobiotix’s corporate development, such as market access studies, business development projects and US affiliate activities
- Loss after tax for the period of €7.8m (H1 2014: loss of €4.1m) in line with expectations
- Cash balance as at 30 June 2015 amounts to €25m (H1 2014: €27m)
Main operational highlights:
- Expansion of soft tissue sarcoma (STS) pivotal clinical trial to three new European countries and submitted clinical authorization requests in other European countries, Asia and Canada, according to plan of the Company
- Positive preliminary safety results for NBTXR3 in head and neck cancer Phase I/II clinical trial
- Appointed new manufacturing partner, CordenPharma, to increase the quantity of NBTXR3 product available ahead of the anticipated CE mark in late 2016
- Professor Robert Langer, Institute Professor at the Massachusetts Institute of Technology (MIT), a renowned nanomedicine expert and serial business innovator, joined Nanobiotix as a Scientific Advisor
Post period end main highlights:
- Start of Phase I/II clinical trials for NBTXR3 in two new indications: liver metastasis and hepatocellular cancer
Laurent Levy, Chief Executive Officer and co-founder of Nanobiotix, said:
“We have made significant advances in the last six months, particularly in the clinical development of our lead NanoXray product, NBTXR3. We are now running clinical trials in five indications: soft tissue sarcoma, head and neck cancer, rectal cancer (by PharmaEngine) and liver cancers (primary and metastatic). This demonstrates the potential transferability of NBTXR3 to be used across different types of cancers. We will continue to expand NBTXR3 clinical development by launching other indications such as prostate cancer, expected in the US by the end of the year. Nanobiotix’s financial position remains strong and in line with the Company’s expectations. We look forward to the productive coming months for our clinical development and remain on track to achieve a CE mark for our lead product in soft tissue sarcoma in late 2016.”
CEO’s Operational Report
There have been significant developments in a number of clinical trials running for NBTXR3 in the first six months of the year. The Company’s clinical developments exceeded expectations and expenses were kept in line with the planned budget. The key highlights of the period are summarised below.
Overview
Nanobiotix is a pioneer in nanomedicine, developing a first-in-class proprietary technology called NanoXray. Nanobiotix’ strategy is to establish a pipeline of products as cancer nanomedicine reference points in the oncology markets.
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