On November 15, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported its unaudited revenues for the third quarter of 2018 (Press release, Nanobiotix, NOV, 15, View Source [SID1234531455]).
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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 EUI- 1202982973v22 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.
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Next financial press release: revenue for Q4 2018 by February 28, 2019
About NBTXR3
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.