On March 30, 2018 – NANOBIOTIX (Euronext: NANO – ISIN:
FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer,reported its audited consolidated results for the fiscal year ended December 31, 2017 (Press release, Nanobiotix, 30 30, 2018, View Source [SID1234525073]):
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Expansion of the Nanobiotix clinical development program activities – seven clinical trials running in eight
indications on 3 continents – in relation to the market access of NBTXR3, Nanobiotix’s lead product, have
impacted operating expenses as planned.
Continuation of the structuration of the Company: several recruitments, notably within the Medical Affairdepartment, opening of 2 affiliates in Europe and preparation of a new manufacturing site.
Consolidation of the cash available at €47.2M strengthened by the completion of two private placements
executed in April and October 2017.
The audited consolidated financial statements for the fiscal year ended December 31, 2017 have been approved by the
management board and reviewed by the supervisory board of the Company dated on March 29, 2018.
Financial statements have been audited
Financial Review
Total Revenue in 2017 amounts to €3.7M vs. €5.4M in 2016, in line with our operational development expectations,
mainly due to:
Revenues from PharmaEngine amounting to €252K (vs. €1,558K in 2016), generated by the recharge of goods
and services provided related to activities planned as per the partnership convention with PharmaEngine; and Other revenues of €3,469K (vs. €3,864K in 2016) mainly related to the Research Tax Credit (CIR), moving in line with the level of R&D activities
Total Operating expenses reach €28.7M in 2017 vs. €27.3M in 2016:
R&D expenses in 2017 were €16.3M, lower than 2016 R&D costs by -€ 0.6M, due to lower clinical development costs as per fluctuation in patient recruitment phases during the year, as well as lower research costs. This decrease is offset by the increase in R&D headcount in the U.S. subsidiary.
SG&A costs reached €9.7M (+€1.4M ), mainly due to some changes in the structure (creation of the COO position in February 2017), and the increase of headcount, as well as consulting fees, hiring fees and communication costs in accordance with the group’s growth strategy.
Share based payment-related costs were €2.6M in 2017 (vs. €2.0M in 2016), being the result of an accounting treatment (having no cash impact)
Total consolidated headcount reached 85 as of December 31, 2017 vs. 67 in 2016, in line with the company’s growth.
Net loss after tax amounts to €26.1M (vs. €21.9M (loss) in 2016), in line with operational development expectations.
Cash available at December 31, 2017 amounts to €47.2M.
In April, the Company completed a private placement of €25.1M providing additional resources to support the group’s development. This operation has been an opportunity for Nanobiotix’s institutional shareholders to reinforce their position and to welcome new shareholders from U.S. and EU.
In October, Nanobiotix successfully completed an approximately €27.2M placement of new shares. This operation
opened the opportunity for Nanobiotix to welcome new investors specialized in life sciences and biotechnology mainly
from the U.S. and from Europe.
The cumulated amount of money raised in 2017 is about €52.3M.
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Nanobiotix activities and achievements in 2017
– Reported positive interim phase I/II data withNBTXR3 in Head & Neck cancer / ASCO (Free ASCO Whitepaper)
– Interim readout and completion of recruitment in phase II/III withNBTXR3 in Soft Tissue Sarcoma
– Advanced phase I/II in HCC/liver metastasis
– Initiated phase I/II in prostate cancer under company IND
– Reported positive IO biomarker study data in STS patients / SITC (Free SITC Whitepaper)
– IND granted to start phase I/II combination study with checkpoint inhibitors
– Company buildout and expansion with the addition of Chief Operating Officer and establishment of European
Operations
2018 perspectives
NBTXR3 is now being evaluated in head and neck cancer (locally advanced squamous cell carcinoma of the oral cavity or oropharynx), and the trial targets frail and elderly patients who have advanced cancer with very limited therapeutic options. The use of Nanobiotix’s NBTXR3 in this population aims to provide better local and systemic disease and prolongs survival with the improvement of Quality of Life.
Given the very promising Phase I/II trial results presented at ASCO (Free ASCO Whitepaper) 2017, Nanobiotix has filed a protocol amendment to expand the study to more patients in order to confirm the efficacy of NBTXR3. Nanobiotix is also planning to open 12-15 additional clinical trial sites in Europe and to expand this study to the U.S. at a later stage.
This indication is critical to establish the medical value of the product regarding the local control of the tumors, the
potential metastatic control through in situ vaccination, and its rare safety profile.
Nanobiotix is running an Immuno-Oncology program with NBTXR3 that includes several studies. In the U.S., the Company received the FDA’s approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibody in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and nonsmall cell lung cancer). This trial that shall start in Q2 2018, aims to expand the potential of NBTXR3, including using it to treat recurrent or metastatic disease.
Many IO combination strategies focus on ‘priming’ the tumor, which is now becoming a prerequisite for turning a "cold" tumor into a "hot" tumor. Compared to other products that could be used for priming the tumor, NBTXR3 could have a number of advantages: it is a physical and universal mode of action that could be used widely across oncology; it involves a one-time local injection; it is a good fit within existing medical practice already used as a basis for cancer treatment; it has a very good chronic safety profile and a well-established manufacturing process.
Nanobiotix is focusing on delivering new clinical and pre-clinical data confirming that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology.
The Company expects to present the results of its Phase II/III trial of NBTXR3 in soft tissue sarcoma in Q2 2018.
In December 2017, regarding the technical file, LNE/G-MED informed Nanobiotix at this time they would need a few more months to finalize the evaluation required for CE marking for soft tissue sarcoma (STS).
Nanobiotix is also running multiple Phase I/II trials in order to widen the usage of the product.
2018 should be another year of growth for Nanobiotix with various milestones:
First patient recruitment in Phase I/II clinical trial in the U.S. looking at the potential of NBTXR3 to transform anti-PD1 non-responders into responders. The multi-arm trial will include recurrent and/or metastatic lung, and head & neck cancer patients
Presentation of the results of Phase II/III STS, when the analysis is complete
First market approval in Europe (CE Marking)
Interim update from Phase I/II head and neck cancer trial with high risk elderly patients
Additional news on other clinical trials and programs