Paris, France and Cambridge, Massachusetts, USA, November 15, 2018 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announces its unaudited revenues for the third quarter of 2018.
Income Statement for the third quarter of 2018
|In €||Q3 2018||Q2 2018||Q1 2018||Q3 2017|
Year-to-date income statement for the nine-months ended September 30th, 2018
|In €||Nine-Months Ended|
Activity and results
Total revenue for the third quarter of 2018 amounted to € 21,816. This brings total revenue for the first nine months of 2018 to € 95,120, which is in line with the Company’s expectations.
All of the revenues generated by the Company during the third quarter of 2018 come from services that Nanobiotix crossed-charged to its partners in accordance with our agreed upon development program operational activities.
In July 2018, Nanobiotix launched a non-dilutive financial partnership with the European Investment Bank (EIB) to boost its research, development and innovation activities. The financing agreement permits the Company to borrow up to €40 million in loans from EIB over the next five years subject to the Company’s achievement of a set of agreed performance criteria. We expect this financing agreement to enable Nanobiotix to accelerate both the development of the Company’s NBTXR3 clinical trial in advanced Head and Neck cancers and to support its European go-to-market strategy.
In September 2018, Nanobiotix presented an update on data from its NBTXR3 development program at the International Conference on Immunotherapy Radiotherapy Combinations. The presentation included updated data related to the Company’s follow-up for its Phase I/II clinical trial in advanced Head and Neck cancers in elderly and frail patients ineligible for cisplatin or intolerant to cetuximab. The data suggests the potential of NBTXR3 to impact survival for this advanced cancer patient population. In addition, the Company presented data obtained from the immuno biomarker study in its randomized Phase II/III clinical trial in soft tissue sarcoma. This data indicated that NBTXR3 activated by radiation therapy could modulate the antitumor immune response.
Finally, the Company’s in vivo investigation of NBTXR3’s mode of action inducing distant immune response on CT26 tumoral model produced data that continues to support the rationale for the use of NBTXR3 activated by radiation therapy to seek to transform tumors into an in situ cancer vaccine and its potential use in combination with immunotherapeutic agents.
Next financial press release: revenue for Q4 2018 by February 28, 2019
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:
- tumors through physical cell death
- metastasis due to immunogenic cell death leading to activation of the immune system
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and Nanobiotix believes it has the ability to fit into current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10 patient populations evaluated in 7 clinical trials.
In June 2018, Nanobiotix established human proof of concept for this first-in-class product in its Soft Tissue Sarcoma (STS) Phase III clinical trial.
NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients that are unable to receive chemotherapy or cetuximab and have very limited therapeutic options. Promising results have been observed from the ongoing Phase I/II trial regarding the local control of tumors.
Nanobiotix is running an Immuno-Oncology development program. In the United States, Nanobiotix has received approval from the U.S. Food and Drug Administration (FDA) to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).
The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.
The first market authorization process (CE Marking) is ongoing in Europe in the STS indication.
About NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading, late clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.
The Nanobiotix philosophy is one rooted in designing pioneer physical based approaches to bring highly effective and generalized solutions to address high unmet medical needs and challenges.
Nanobiotix’s first-in-class, proprietary lead technology, NanoXray, aims to expand radiotherapy benefits for millions of cancer patients. Furthermore, Nanobiotix’s Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.
Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP). The Company’s headquarters are based in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in Spain and Germany.
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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 filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.17-0470 on April 28, 2017 as well as in its 2017 annual financial report filed with the French Financial Markets Authority on March 29, 2018 (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. At the moment NBTXR3 does not bear a CE mark and is not permitted to be placed on the market or put into service until NBTXR3 has obtained a CE mark.