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| Statement |
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| It's been a very busy first half, and I would say, very exciting for Inventiva |
| And also, we've shown recently to have a strong insulin synthesizer effect |
| So extremely happy we will benefit from the support of Steve for this trial |
| As I mentioned you have seen that the operational activities on the different studies have been very strong and it's derived from this activity |
| You know that we have been -- we have embarked in the licensing strategy, and we are very pleased on the progress made by our partner in China, Sino Biopharm, CTTQ |
| Lani treatment significantly improved both hepatic and peripheral insulin sensitivity, which translated into better glycemic control |
| The geographic reach of NATiV3 is larger than NATIVE, which was mainly conducted in Europe, which is a plus advantage because we have data from more representative patient populations globally, which is also relevant for the United States and for the FDA |
| The first, as you know, we reported during the first half, positive top line results with the investigator-initiated study conducted by Professor Ken Cusi evaluating lani in patients with NAFLD and Type 2 diabetes |
| More so, we improved adipose tissue dysfunction with a robust increase in plasma adiponectin |
| So very briefly, I think [technical difficulty] this moment are quite important because we can look back at what we have achieved, and I think we can be proud of what we achieved or the milestones that have been met over the last months, both for lani and of course, for our finances |
| This new design has been implemented since the beginning of the year, and now we have over 80% of our sites that have adopted this new protocol, and we start to see major improvement |
| We have achieved that |
| The demonstration that lanifibranor has a very potent effect on insulin resistance, not only in the liver, but also in skeletal muscle, so in adipose tissue and related to that, the improvement of the metabolic market, specifically with regard to adipose tissue or steatosis in the liver |
| And then also we're very happy to see that screen failure continues to decline month-on-month, and this is a trend that has started in September '23 |
| Do we plan other combinations? Obviously, today, in addition to SGLT2 inhibitors in this field, the GLP-1 receptor agonists have seen a quite explosive growth in their use for weight reduction also for the treatment of Type 2 diabetes, specifically semaglutide |
| Cusi, the treatment with lanifibranor 100 milligram once daily for three months was well tolerated with no safety concern reported |
| Lani is very well placed to make it to the finish line in NASH |
| We aim to continue this positive train by targeting the end of recruitment of the end of the year, with the first result of the combo trial with empag at the end of first quarter |
| The renal impairment study is complete indeed with very good results |
| We have submitted this good result, this promising results to the upcoming AASLD Congress, and we plan to have them published in a peer-reviewed journal |
| We have a very competitive profile |
| And these are all the possibilities to continue reinforcing our cash position short and medium term |
| But more importantly, what gives us hope in the future is our lani asset |
| So on top of that, given the competitive landscape and where we stand with our Phase 3 compared to competition, we are convinced that lanifibranor will play a key role in treating patients with NASH |
| Other income increasing at EUR4.7 million |
| It's a oral drug, oral compound, and it is efficacious, both on NASH resolution and has a direct anti-fibrotic activity |
| Sino Biopharma has elected to join our global pivotal trial, and we are pleased to report that the first site has been activated this week and that the first patient has already been screened |
| So we do have a geographic reach that I think also addresses the requirement to have a diversity in the patient population, which is good |
| This strategy allows to conduct a confirmatory trial that is easier to implement versus the one contemplated in the original design, will allow us potentially to expand the addressable population beyond patients with F2 and F3 fibrosis to patients with NASH and compensated cirrhosis |
| First of all, the capital raise that Frederic talked about gave us the opportunity to have new shareholder on the Board, on top of existing shareholders who have also participated |
| Statement |
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| Of course, and I think it's a consensus -- it's also why there is a kind of a negative unfavorable pressure, I would say, on our target price |
| There is an overhang on which we are working |
| And bottom line, we have a net loss -- we reached a net loss of EUR55.3 million compared to EUR29.5 million, and this is as expected in our projections |
| And then secondly, on -- just on the R&D spend, I'm just slightly struggling even with the milestones, EIB loan and recent upfronts and raise to get my cash runway to match |
| This is not worrying |
| For example, we have reduced the number of biopsy from three to two |
| We have not benefited from the foreign exchange between euro and dollars, as last year because the dollar has weakened during the semester |
| So you were a bit cut |
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