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Accumulating data for NBTXR3 and IO combo

Update | Pharmaceuticals & healthcare | 02 Feb 2017

Nanobiotix has made progress with NBTXR3 as a standalone agent to enhance radiation therapy and now has clinical data from three cancers demonstrating consistent safety, feasibility and transferability of effect across different indications. Nanobiotix has also released preclinical results demonstrating NBTXR3’s ability to enhance the immunogenicity of various cancers, which is the cornerstone idea behind the immuno-oncology (IO) products. We expect an eventful 2017, with several clinical trials reporting results and a potential CE mark approval in mid-2017 for use in soft tissue sarcoma (STS). Our valuation has increased to EUR 738m.


Imminent data from two lead clinical trials

Outlook | Pharmaceuticals & healthcare | 31 May 2016

The next 12 months will deliver a number of catalysts for Nanobiotix. Readouts from a Phase I/II study with head and neck (H&N) cancer and a Phase II/III study with soft tissue sarcoma (STS) patients are due any time now. H&N cancer will be the second indication with clinical data for Nanobiotix's lead product NBTXR3, which may have a de-risking effect on other indications in the pipeline due to the physical property of NBTXR3 to universally enhance the effect of radiotherapy. Our valuation of Nanobiotix is €543m.


Plenty of triggers in 2016

Update | Pharmaceuticals & healthcare | 01 Feb 2016

2016 started on a positive note for Nanobiotix, with the IND for lead product NBTXR3 approved in prostate cancer. The company is running trials across six indications, some of which will deliver key data this year. Results from the pilot Phase I/II H&N cancer trial are due in H116, followed by a hallmark event o interim pivotal STS trial data o in mid-2016 and an expected CE mark approval by end 2016. Another two Phase I/II studies for liver cancers are also due to report in H216. Our rNPV increases to €527m.


NBTXR3 clinical trial starts in liver indications

Flash note | Pharmaceuticals & healthcare | 08 Jul 2015

Nanobiotix has been granted approval in France to commence pilot clinical development with NBTXR3 for the treatment of liver cancers, allowing the start of a Phase I/II study in line with expected timelines. Liver cancers (including both primary and liver metastases) represent the next indications for NBTXR3, with trials in soft tissue sarcoma (STS), head and neck (H&N) cancer and rectal cancer ongoing. Our valuation is €505m.


Safety data further de-risk NBTXR3

Update | Pharmaceuticals & healthcare | 15 Jun 2015

Nanobiotix has reported initial NBTXR3 safety data from the ongoing H&N cancer pilot study. These data are important in confirming the safety of NBTXR3 in another tumour type, in addition to the feasibility of NBTXR3 injection directly into H&N tumours. There were no SAEs and NBTXR3 remained within the tumour, consistent with STS. The trial will now be expanded to include patients receiving both chemo- and radiotherapy. Our valuation is increased to €505m with a higher H&N probability of success.


Multiple NBTXR3 events upcoming

Update | Pharmaceuticals & healthcare | 20 May 2015

Nanobiotix remains on track with its NBTXR3 development strategy. First CE mark approval continues to be targeted in STS in Europe by end 2016, in addition to a broad clinical development plan and go-it-alone US and EU commercial strategy, supported by financings during 2014. Clinical trials are already ongoing in both STS, which was recently expanded, and head & neck cancer, and trials in prostate and liver cancers are expected to start in H215. A manufacturing partner was recently appointed to ensure sufficient supply of NBTXR3. Our valuation is largely unchanged at €483m.


Data, dollars and development updates

Update | Pharmaceuticals & healthcare | 09 Jan 2015

During 2014 Nanobiotix continued to progress lead product NBTXR3, with positive data leading to a refined development strategy that could allow for first CE mark approval in STS in Europe by 2016. Capital increases and additional future commitments should allow Nanobiotix to continue with its recently expanded NBTXR3 development strategy and go-it-alone US commercial plans. During 2015 we expect more NBTXR3 clinical data from ongoing trials and the start of further trials under the current strategy.


Looking to the future with a strategic investor

Update | Pharmaceuticals & healthcare | 04 Dec 2014

Nanobiotix has announced plans to commercialise NBTXR3 alone in the US, rather than with a partner, which should be a more profitable strategy. This has been facilitated with a €10m private placement with a US investor, also securing potential future €24m funding. Indications to be pursued in US/Europe include STS (pivotal trial ongoing), head and neck cancer (pilot trial ongoing), in addition to liver cancers (including liver metastases) and high-risk prostate cancer. Our updated valuation is €464m (from €332m).


Approval to start STS trial as expected

Update | Pharmaceuticals & healthcare | 17 Oct 2014

Approval to start the pivotal Phase II/III trial of NBTXR3 in soft tissue sarcoma (STS) has been granted in France, allowing the start of this study in line with expected timelines. Approval in other countries in Europe, in addition to Asia Pacific in partnership with PharmaEngine, will allow the trial to expand to further centres. If the trial progresses as planned, this could allow for first product CE mark registration of NBTXR3 in Europe for STS at end 2016. We make no changes to our €332m valuation.


Global progress

Update | Pharmaceuticals & healthcare | 14 Oct 2014

Nanobiotix's Asian partner PharmaEngine will collaborate on the planned pivotal soft tissue sarcoma (STS) trial, expanding the trial to Asia-Pacific. Thus, as some patients will now come from Asia-Pacific funded by PharmaEngine, this could reduce Nanobiotix's financial contribution to the trial, and could accelerate approval in Asia-Pacific. In the US, Nanobiotix has recently taken additional steps towards increasing its presence in the key US market by opening an affiliate office in Boston and appointing a key hire. Our valuation is increased slightly to €332m with these changes.


A small product with big prospects

Outlook | Pharmaceuticals & healthcare | 19 Jun 2014

Nanobiotix has delivered on a number of key milestones in the last year, with positive NBTXR3 first-in-man soft tissue sarcoma (STS) data. A pivotal trial in this indication is due to start by end 2014, which should allow for first approval in Europe by end 2016. Start of trials in Asia-Pacific, an update on the US strategy and data in head and neck during H214 will all broaden the reach of this unique cancer treatment. Our valuation is €321m.


Capital raise allows execution of strategy

Update | Pharmaceuticals & healthcare | 12 May 2014

The successful €28.1m capital increase in March should allow Nanobiotix to execute on its refined NBTXR3 strategy aiming for first CE mark approval in soft tissue sarcoma (STS) in 2016. Our valuation has increased to €315m with incorporation of the additional funds (from €282m). The next key catalyst will be presentation of STS data from the pilot trial at the high-profile ASCO conference in June.