Nanobiotix 2015 Q4 and Annual Revenues

PARIS--(BUSINESS WIRE)--Regulatory News:

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

In €	12/31/2015 (12 months)	12/31/2014 (12 months)
Revenue	265,543	972,908
Of which:
License	183,893	967,500
Services	15,471	5,408
Other sales	66,179	-

Revenue for Q4 2015

In €	Q4 2015	Q3 2015	Q2 2015	Q1 2015
Revenues	124,727	47,636	46,189	46,991
Of which:
License	46,351	46,351	45,160	46,031
Services	12,197	1,285	1,029	960
Other sales	66,179	-	-	-

Activity

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

Next financial press release: annual results of 2015 by 29 April, 2016

-Ends-

About NANOBIOTIX: www.nanobiotix.com

Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company’s first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients.

NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration.

Nanobiotix’s lead product NBTXR3, based on NanoXray, is currently under clinical development for soft tissue sarcoma, head and neck Cancer, prostate cancer, rectal cancer (PharmaEngine) and liver cancers (HCC and liver metastases). The Company has partnered with PharmaEngine for clinical development and commercialization of NBTXR3 in Asia.

Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarter is based in Paris, France. Affiliate in Cambridge, United States.

Disclaimer

This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix registered by the French Autorité des Marchés Financiers on January 12, 2016 under number R. 16-001 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements.

This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country.