PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:
NANOBIOTIX (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 2016 and outlines its updated share capital breakdown as of 30 June 2016.
Laurent Levy, CEO of Nanobiotix, commented: “We are pleased with the progress made during the first half of 2016. The company has announced successful clinical results from our Phase I/II Trial of NBTXR3 in Head & Neck Cancer, bringing us a step closer to proving the transferability of our approach across other cancers. The private placement completed in March 2016 enabled new investors, mainly from the US, to invest in Nanobiotix and puts us in a strong position to remain well funded until mid-2017. The promising proof of concept results for our new immuno-oncology preclinical research program show that NBTXR3 may also enhance immunogenicity of the tumor. We expect this momentum of positive clinical and operational developments to continue in the coming months.”
Financial highlights
- Total revenue of circa €3m (H1 2015: €1.7m) includes the pro-rata share of the initial upfront payment from PharmaEngine (€92k), a milestone payment of $1.0m (€890k) from PharmaEngine, research tax credit (€1.991k) and other subsidies (€63k)
- Increase of expenses corresponds to progression and expansion of clinical development, with five clinical trials running in six indications, and market access activities, according to plan
- R&D expenses and SG&A costs amounted to €8.2m and €3.8m respectively. These remain fairly constant over the half year, consisting of 69% and 31% respectively of the expenditure incurred in H1 2016 (H1 2015: 68% and 32%)
- Loss after tax for the period of €10m (H1 2015: loss of €7.8m) in line with expectations
- Cash balance as of 30 June 2016 amounts to €25m (H1 2015: €25m)
Financial events
- Successful completion in March 2016 of a €21.3 million private placement of new ordinary shares primarily subscribed by life sciences specialist investors, the majority of which are based in the United States
- Received a milestone payment of $1.0m (€890) from PharmaEngine, the Company’s Taiwanese partner, triggered by the first patient undergoing treatment in Nanobiotix’ Soft Tissue Sarcoma (STS) phase II/III in the Asia-Pacific region
- Exercise of warrants by Capital Ventures International (CVI) giving access to 50,000 ordinary shares representing a share capital increase of an aggregate amount of €893,500
Operational highlights
- The US Food and Drug Administration (FDA) approved the Company’s Investigational New Drug (IND) application. This allows Nanobiotix to launch its first clinical study in the US for its lead product NBTXR3 in prostate cancer, a new and very significant indication
- Preliminary preclinical proof-of-concept (POC) established with the lead product, NBTXR3, for its new program in immuno-oncology (IO) started in January 2016. The first promising data showed that NBTXR3 might be used not only to destroy tumors (as it is currently being clinically developed), but also to amplify the power of radiotherapy to create intratumoral vaccines for IO, enhancing the immunogenicity of the tumor
Post period end main highlights
- Successful results from Phase I/II Trial of NBTXR3 in Head & Neck Cancer
Financial Review (IFRS)
| The detailed Profit & Loss financial statement is laid out below: | ||||
| 6 months period closed on : | ||||
| (€ ‘000) | June 30 2016 | June 30 2015 | ||
| Operating revenue | 982 | 91 | ||
| Other revenue | 2,054 | 1,568 | ||
| Subsidies | 63 | 139 | ||
| Research Tax Credit | 1,991 | 1,429 | ||
| Total revenue | 3,036 | 1,659 | ||
| Cost of sales | - | - | ||
| R&D costs | -8,209 | -6,124 | ||
| General costs | -3,773 | -2,848 | ||
| Costs associated with payments in shares | -1,127 | -559 | ||
| Core operating loss | -10,073 | -7,872 | ||
| Income from cash | 35 | 116 | ||
| Gross cost of debt | -49 | -4 | ||
| Net cost of debt | -14 | 112 | ||
| Other financial income | 15 | 3 | ||
| Other financial expenses | -6 | -16 | ||
| Core pre-tax loss | -10,079 | -7,773 | ||
| Tax | -89 | - | ||
| Net loss | -10,169 | -7,773 | ||
| Profit and loss recognized directly in shareholders' equity | 21 | 211 | ||
| Foreign exchange translation adjustments | 5 | -5 | ||
| Global results | -10,143 | -7,567 | ||
| Diluted earning per share | -0.68 | -0.52 | ||
Total revenue for H1 2016 amounts to €3,036k (H1 2015: €1,659k) mainly due to:
- the pro-rata shares of the initial upfront payment from PharmaEngine, received in August 2012 and linearized on an annual basis for €184K/year, amounts to €92k
- a milestone payment of $1.0m (€890k) from PharmaEngine, triggered by the first patient undergoing treatment in Nanobiotix’ Soft Tissue Sarcoma (STS) pivotal phase in the Asia-Pacific region
- other revenue of €2,054k mainly from Research Tax Credit (CIR) that has risen sharply due to higher levels of R&D activities and the acceleration of the global clinical development program, with five clinical trials running in six indications in the USA, Europe and the Asia-Pacific region
Total operating expenses as of 30 June 2016 reached €13.1m (H1 2015: €9.6m) due to:
- costs in H1 2016 amounted to 11,982k, representing an increase of 34% compared to H1 2015. This corresponds to the launch of new clinical trials, expansion of STM pivotal phase, NBTXR3 market access and launch preparation activities, and the development of Nanobiotix’s US affiliate
- R&D expenses up to €8.2m (H1 2015: €6.1m) to support extending the research scope of the Company, starting the liver and prostate cancers clinical trials, and launching the preclinical research program in immuno-oncology
- general cost expenses reached €3.8m (H1 2015: €2.8m) mainly due to an increase in the resources available for NBTXR3 market access, launch readiness activities and the increase in staffing costs
- R&D expenses and SG&A costs amounted to €8.2m and €3.8m respectively. These remain fairly constant over the half year, consisting of 69% and 31% respectively of the expenditures incurred in H1 2016 (H1 2015: 68% and 32%)
The core operating loss amounts to €10m (H1 2015: €7.9m) in line with expectations. This operating loss increased sharply and remains in close correlation with Nanobiotix’s business and activities.
The total net loss amounts to €10.2m.
Cash balance as of 30 June 2016 was €25m as per expectations.
The shareholding structure remains similar to how it was in December 31, 2015. However, following the successful completion of the private placement in March 2016, the majority of new qualified and institutional investors that became shareholders are based in the US. This has altered the composition of the Company’s institutional investors.
In total, institutional investors now hold 43% of the shareholding (vs. 38% previously) and family offices hold 9% (vs. 13% previously).
Finally, retail and management shareholders remained at the same level with 42% and 6% respectively.
