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| Statement |
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| So, we're excited about being able to focus on sharing updates with you and the markets with regards to what is coming over the next 12 months, and we're very pleased to be in this position |
| Nanobiotix has had an extremely productive quarter, and we believe that the company's position has been completely transformed into one where we have set the stage to allow us to deliver on the potential of NBTXR3, a pipeline-in-a-product |
| On top of that, our partner, MD Anderson has been publishing data on pancreatic cancer showing a good feasibility and safety of this treatment for those specific patients, but also starting to see some strong signal of efficacy |
| So, all this is just confirming that our product does provide a good impact in terms of response that induce an improved PFS and potentially improved OS, too |
| So, being able to see such an improvement of such a PFS and OS in a population with such a high comorbidity, for us, is a very good sign of the efficacy of our product |
| And if we think that in overall, a larger population will perform better than the nine and 12 months, then our product should also perform better in a better population |
| So, this is not a new product because we've been able to demonstrate in hundreds of patients safety and first sign of efficacy, including a strong proof of concept in soft tissue sarcoma where in a randomized trial, we've been able to show the superiority of our treatment versus the standard of care |
| So, that's why we think we have a good room to play in that regard for success of the 312 trial |
| We've started this quarter by signing this $2.5 billion collaboration with Johnson & Johnson and gave a number of updates, including final data of our Head and Neck Phase 1 trial plus some exploratory data through ESMO and ASTRO that gave us some strength and some confidence about the potential outcome on the ongoing global Phase 3 |
| As you may have seen in our press release, you could see that we have had a very productive and busy quarter that we think is going to drive Nanobiotix into a great future |
| HfO2 is, first of all, a very stable inert material, which is good in terms of safety, but also provide a very unique property, being a very strong X-ray absorber, because of the nature of the materials and the high atomic number and density of electron that compose it |
| So, in a nutshell, moving to Slide 15, so we've been able to successfully administer this product into patients with a good safety profile |
| As you will see, our recently completed financing round, we really strengthened our financial position, and Bart will give you an update on that |
| And the fact that we have been observing this high rate of response, 80% or more, and this is linked to a very strong survival with the median survival of 42.8 months, really let us think that we may be on our way to change the outcome for this patient population |
| We are grateful for the continued support we are receiving from existing shareholders and are pleased to welcome new shareholders to the journey |
| So, we concur, I think what MD Anderson has provided as the first data in pancreatic cancer are very encouraging and interesting |
| As you can see, we have had a very busy quarter that we think is going to help us to pivot Nanobiotix into a great future |
| In our case, with one less chemo, but our product NBTXR3 in combination with radiation, we got to 23 months, which shows a potential improvement for those patients |
| And as you've just heard Laurent discuss, additional indications such as pancreatic cancer can, we believe, benefit from adding our potentially first-in-class radioenhancer to the treatment armamentarium |
| Importantly, on the top of safety, we've been showing a very high response rate, 79% of our response rate |
| We start getting a good potential signal of efficacy for the 23 months median overall survival |
| We're pleased to share with you that we removed the finance overhang that we did away with the EIB cash covenants and extended our runway into mid-'25 |
| So, what is important is to see, can you get response, because we know that getting a good response will provide a good PFS and a good PFS will provide a good OS |
| Our hypothesis is if you get less patient with high comorbidity, meaning more patients that will have time to get the benefit of the treatment, we should be able to see even bigger or better results in the Phase 3 |
| First of all, what we've been observing in the Phase 1 with a good median PFS and a good overall survival when you look at the population we are treating, and in the Phase 3, there are two differences that we think would be again an improvement versus what we have seen in the Phase 1 |
| So, those two together are very good surrogate for us of efficacy of our product |
| So, I think this is a very good first step to see that we have more patients getting to normalized CA19 with a good amplitude plus the OS that we start to see in this ongoing trial of 23 months |
| So, all those data and final data of this Phase 1/2 gave us a lot of confidence to the management and to our investigator about the potential success of the ongoing Phase 3 |
| And so, how do we read that versus the 102? First of all, the 312 will be positive if we get the tested arm with our product plus radiation to 13 months as the PFS instead of nine and 16 months for the OS, which is a lower burden than what we've been observing in the available population in the 102 |
| If you move to Slide 24, I think there are a few things that make us really confident in the potential outcome of the Phase 3 |
| Statement |
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| We believe the quarter has also seen the company address in a significant manner the financial overhang that has been an understandable concern of capital market participants |
| So, in general, in this patient population, when you got high CA19 at baseline, it's a very bad prognosis |
| They are subject to significant risks and uncertainties that could cause the company's actual results to differ materially from our current expectations |
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