P aris, France, February 26, 2016 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage Nanomedicine company pioneering novel approaches for the local treatment of cancer, today announces its unaudited revenues for Q4 and the annual revenues for the year ended December 31, 2015.
Revenues at December 31, 2015
Revenue for Q4 2015
|in €||Q4 2015||Q3 2015||Q2 2015||Q1 2015|
Nanobiotix’s revenue during the fourth quarter of 2015 corresponds to the upfront payment (pro-rata share) from Taiwan-based PharmaEngine. This is within the framework of the licensing contract signed in August 2012 for the development and commercialization of the lead NanoXray product, NBTXR3 in the Asia-Pacific region. The upfront payment totaled €810,640, generating revenue of €46,351 over the period and is distributed using the straight-line method of apportioning the revenue across the period between the date the contract was signed and the scheduled marketing launch in the region.
The invoicing of services and other sales respectively totaled €12,197 and €66,179 for Q4 2015. In total, revenue for the Q4 amounted to €124,727 which is fully in line with Company expectations, totaling €265,543 for the year.
In November 2015, Nanobiotix announced the dynamic expansion of its pivotal phase II/III trial for NBTXR3 in soft tissue sarcoma (“Act.in.sarc” study) in 29 sites in 7 countries. The patient recruitment rate is increasing in line with the Company’s expectations. This study is expected to be the final step before getting CE mark which is anticipated towards the end of 2016. For information, today, the trial is running in 10 countries.
Post period end main highlights
Nanobiotix announced on 4 January 2016 that the US Food and Drug Administration (FDA) had 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. With the addition of this prostate cancer trial, NBTXR3 is now tested in a total of six indications.
On 5 January 2016, Nanobiotix announced the start of a new research program, in immuno-oncology, with its lead product NBTXR3, in addition to its current advanced clinical development program. Indeed, NBTXR3 could have the potential to bring a new dimension of immunotherapies in oncology.
Forthcoming communications expected:
- Head & neck cancer: Phase I/II results expected in H1 2016
- Soft tissue sarcoma: Phase II/III pivotal study interim data readout expected mid 2016
- Liver cancers (HCC and liver metastases): intermediate results of the Phase I/II study in the different patient’s populations expected H2 2016
- Immuno-oncology research program: first preclinical results expected this year
- Expected CE mark end of 2016
- Indications developed in Asia-Pacific: information to be published by PharmaEngine according to their own calendar
2016 Financial Calendar
Nanobiotix will announce its financial and operating results according to the following indicative calendar:
- April 29, 2016 – Annual results
- May 13, 2016 – Revenue for Q1
- Before June 30, 2016 – Annual General Meeting Paris, France
- July 13, 2016 – Revenue for Q2
- August 31, 2016 – Half year results
- November 15, 2016 – Revenue for Q3