Investors in pioneering cancer firm Nanobiotix (EPA:NANO) can look forward to a data-rich 2016, which will hopefully culminate in a CE mark for its lead candidate, meaning it can start to market, and importantly, sell the product for soft tissue sarcoma (STS) in Europe.
Last year's greatest success was preparing for a big 2016, explains a half-joking chief executive Laurent Levy.
The firm's lead medicine NBTXR3 began pivotal clinical trials for STS - a form of tissue and muscle cancer, about a year ago and if positive interim data on two thirds of the 104 patients is forthcoming in mid-2016, it can file for the key CE mark.
But before that, at the end of the first semester, the Paris-listed firm is expecting the first set of data from Phase I studies for head and neck cancer, which could later spring it into the registration phase - a precursor to a CE mark. Also expected in the latter part of the year is first safety and feasibility data from trials of liver cancer - primary and metastatic.
Not bad for a company that only conducted its first pilot studies for STS on 25 patients around three years ago.
But that the firm's ground-breaking technology has such potential to treat so many cancers types, and embrace a wide global market is key to its investment proposition.
Respected US investment bank Piper Jaffray, in a September note, describes Nanobiotix as a leader in "radio-enhancing nanotechnology".
That's because, in simple terms, the firm has, using physics, developed a nanomedicine, which is injected into the body, making traditional radiotherapy, (already a proven treatment) more effective.
Levy explains how many other nano firms have developed what he calls "helping drugs nanotechnologies ", which are aimed at improving targeting the tumour or better delivery, but his company uses nano alone.
"We get rid of the biology and its variability and don't specifically target something in the body. We just target a tissue, not a receptor or molecular entity. That's a different mindset and that's where the value is (of Nanobiotix)”.
Feedback from radio-oncologists has been positive, he reveals. They understand the technology and the benefits it can bring to patient outcomes.
Charles Duncan, analyst at Piper, has said the market still fails to fully grasp that NBTXR3'S efficacy is based on proven, killing of radiotherapy, a treatment received by 60% of all cancer patients.
"Therefore, probability of success in one or more tumour types is much higher than the average oncology candidate, in our view," he said.
He kicked off covering the stock with an 'overweight' stance and €25 target price - a long chalk from the current price of around €15.
It's worth highlighting here the other recent key news from the group, which underlined its reach - its first clinical entry into the USA - the largest clinical market in the world.
NBTXR3 was approved by the FDA (Food and Drug Administration) as an investigational new drug (IND), which means it can start a phase I/II clinical trial for prostate cancer, the second most common cause of men cancer in the US, and Levy says news will come soon on protocol details and expected dates for data.
And the clinical pathway is racing along.
In the US last year, according to estimates almost 12,000 new soft tissue sarcomas were diagnosed and Piper reckons sales of Nanobiotix's medicine could reach more than an eye watering €500 mln in 2027 for STS, H&N and liver in the US and EU.
Levy will not be drawn on the exact nature of how NBTXR3 will be sold, once it gets its CE mark in Europe, though he says a mix of direct sales and partnership is likely.
The entry into the US is also significant since the stock is underfollowed there, and the firm is not listed on NASDAQ. Levy has nothing to say on a potential listing at this point, though does not rule it out.
So, this year is certainly shaping up to be exciting for investors.
Nanobiotix is in a field of its own and financially well positioned to execute on plans, holding €25mln of cash as of last June. All together the company should have enough cash to cover the development up to end of 2016.
Excitingly, it also now has a new field of application for NBTXR3, which Levy says should throw up some pre-clinical data this year - namely the use of this nanomedicine as a in situ (intra tumoral) vaccination for Immuno Oncology.
Piper Jaffray reckons the news packed agenda over the next two years should help address the “inefficiencies” of the market’s perception of the stock and increase investor interest.