Inventiva S.A.

Thank you, good morning, good afternoon, everybody, and thanks for joining us today for this webcast. Before we begin, as usual, I ask you to please read the disclaimer on slide two, which should appear now, and I want to remind everyone that the various statements that we may make during today's conference or during the Q&A session will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Today, in this call, I'm joined by Jean, Jean Boulatier, our CFO, and by our CFO and co-founder, Pierre Broca. So let me go back to some of the highlights of Lani Fiber Nord development program by starting by 1983. So in January 23, we announced some important changes to the design of the phase three, evaluating Lani inpatient with MASH-NASH. which made the study more attractive for the site and especially more patient-friendly. This new design is based on discussion we had with the FDA and on the alternative approach put forward by the US FDA, which includes two independent phase three, one based on histological outcomes, native three, which would allow us, if our results are positive, to fight for accelerated approval. And the second phase three study in patients with MASH, NASH, and compensatory cirrhosis, which will be our confirmation trial in order to demonstrate clinical outcomes and which would secure a positive full approval. As part of the development of Lani, we were pleased that our partner, Sinobiopharm, received their IND approval by the Chinese and MPA to initiate the clinical development in China. Sinobiopharm is participating to our Global Native III Phase III clinical trial, and we have closed 2023 with the first patient enrolled in China and also a breakthrough therapy designation granted by the NMPA in China, making Lani the first drug candidate, to our knowledge, to receive such designation from both the FDA and the NMPA for the treatment of MASH-NASH. We also published the results, the positive results of a study conducted by Professor Cusi from the University of Florida in 2003, in 2023. The study met its primary endpoint, which demonstrated the reduction of intra-hepatic triglyceride in patients with MAFLD and NAFLD and type 2 diabetes treated with a low dose of Lani for six months. What was key in this study showing the effect on hepatic fat and liver and muscle insulin sensitivity, as well as fat metabolism within just 24 weeks. The effect on insulin sensitivity is an important feature and key differentiator of Lani versus other therapies approved or in development in NASH as insulin resistance is a feature of all NASH patients. We have also been active on licensing. as we also announced the licensing of Lani in Japan and South Korea with the signature of an agreement with the Palace Pharma. This is an exciting milestone and expands our potential footprint. With this agreement, we have received a 10 million up from payment and exercise our right to take a stake ownership in the newly created company. In February, We reported the first SUSAR ever experienced with Lani, and this as we were approaching the end of our screening for N83. Our team has been and is all hands on deck. We have made the changes to our protocol as recommended by our data monitoring committee, and we're today back on track. We have resumed screening, and also we have started randomizing new patients in the majority of our site under central IRB in the US. And we confirmed that we target last patient first visit in first half of 24. Finally, just last week, we announced the positive interim analysis of our proof of concept phase two clinical trial legend, evaluating the combination of NANI with SGLT2 inhibitor and baguette flosing. The study was designed to potentially demonstrate an additive effect of the combination and the management of weight gain that can be observed in some patients treated with lanifibrinoid. The study met its primary endpoint, which was the reduction of HbA1c, and demonstrated that the combination addresses the moderate and metabolically healthy weight gain seen in some patients. The study showed that both Lani alone and in combination with EMPA induce a redistribution of fat from visceral to subcutaneous fat, reflecting a shift from pro-inflammatory visceral fat towards medically, metabolically healthy adipose tissue. This redistribution of fat is consistent with improved insulin sensitivity seen with both Lani alone or the combination. Finally, Lani improved markers of cardiometabolic health. The effect size appears to be further improved when Lani is combined with EMPA. These results further bolster our robust data set, our faith to be native, and from the investor initiative study conducted by Professor Luzi. We plan to present this data in scientific congresses, as well as submit it for publication. We briefly cover several key financial milestones before turning it over to Jean. In 2023, we have secured the financing of approximately $39 million with equity issuance. We also have secured $15 million of non-dilutive. Five, our partner in China following the progress made in the development of Lani. And then an additional 10 million with the signature of the licensing agreement with Epalis Pharma, which also make us eligible up to $231 million of clinical, regulatory and commercial milestones, as well as royalty. And also, as you are aware, at the beginning of the year, thanks to the achievement of key financial and operational milestones, we drew the second tranche of the 50 million euro EIB alone, We're in the second tranche for those 25 million. We are very optimistic for the future of Lanny Fiebernord and Inventiva, and are focusing on the upcoming important milestone, which is for us, the last patient, first visit of Phase 3, Native 3 clinical trial, which we expect to secure by the first step of this year. Let me give you some figures that make us confident that we can achieve this target. We have more than 75% of the patient targeted to be randomized in the main cohort, and more than 350 are in screening. Importantly, close to 90% of the patient randomized come from North America and EU, which we think bodes well for the quality of the result. From a financial standpoint, and I'm We are, of course, focusing our efforts to expand our cash runway, and we're confident that the recent positive data from Legend, the progress made in 83, and the approval of Resmeteron with no requirement of biopsy for prescribing the drug create a favorable environment for Inventiva. The management of patients with NASH-MASH will require treatment options and potential combination therapies. And we certainly think that given lanifebranor dataset and mechanism of action, there is a significant space for a neural drug with a direct antifibrotic activity and strong insulin sensitizer like lanifebranor. This was clearly highlighted in the recent physician survey we conducted in the U.S. showing prescriber expect to write lanifebranor for approximately 30% of their matched patients. We now turn it over to Jean, We will provide you with an overview of our full year 23 financial reports.

Thank you, Frederic. Good morning. Good afternoon, everyone. So everything has been said, I may say, and the financials for 23 reflect quite rich activities, as you have heard. Let's start with the profit and loss accounts. So the company's revenues for this year amounted to 17.5 million. I guess a record ever for Inventiva since it has been created. So an increase by more than 40% compared to the 12.2 million recorded in 22. I said the revenues, you know, derived from two things. First, the continuing milestones, two milestones from CTTQ Sinogyo Farm, the Chinese partner. five million dollars and also for the two-thirds of the revenues in 23 from the up front payment of 10,000 million dollars from Mepalis and also a non-cash consideration from the fair value of an option to acquire shares of the JV. The key thing is of course the increasing effort in R&D, so an increase of 82%, reaching 110 million in 23 compared to 60.5 million in 22. Obviously, this reflects the acceleration, planned acceleration in the 23 activities with regard to the clinical development for NATIVE-3, and also in a lesser extent with the LEGEND phase 2a combination trial we have just talked about. GNA expenses amounted to 13.8 million, a slight increase of 7% compared to the 12.9 million in 2022. We consider it's rather under control, considering the growing scope of activities of the company. To be outlined also, a net financial income of 5.1 million, a loss which reflects, we've talked about the EIB first tranche in 23 with interest rates, which would be paid, I remind that end of 26, early 27. But of course, we incur the expense related to this loan and also completed by some interest that we pay for the other existing minor loans. The variation in net financial income is also due to close to zero foreign exchange results in 2023 compared to a greater positive result in 2022. This is obviously related to the euro-dollar context in 2023 compared to last year. We record for the first year our share of net loss for the stake we have in the Japanese JV with a non-cash loss of 12 million, of course, compared to zero in 22. And all things considered, the company's net loss for the full year reached 110.4 million compared to 54.3 million in 22. Let's talk now about cash. If we consider what we call a global cash position, you know, including the pure cash and cash equivalent, the middle-term investment we have that are very liquid and easily mobilizable, and the second trench of the European Investment Bank that we drew mid-January, we started the year with close to 61 million in cash compared to 88.4 at the beginning of the prior year. So it's a decrease of close to 30 million. Obviously, it reflects the higher cash consumed by the operations, 82 million, including, by the way, the 20 million cash in, definitely deriving from the effort in the R&D. By the way, in terms of metrics for the IR&D, we must underline that Lannis-Ibranor is really focused in our financial efforts. R&D in the company represents 87% of overall expense, Of this R&D, of this 87%, Lani Fibrenor represents 85% of this R&D expense. And overall, for the company, 75% of our financial efforts are dedicated to this program. So the negative impact, of course, of the operating cash flow has been partially offset by the operation that Frederic reminded. First end of August, the finance rate of 35.7 growth in regular capital increase. For such an increase, we got the support from existing partners, such as Sofinova and Young Capital. And also, we're very pleased to welcome Qatar Holding LLC, who now holds close to 10% of our shareholder base. The negative operating expense has been also offset, as mentioned, by the $10 million upfront payment from Mepalis and the $5 million related to the two milestones reached with CTTQ, first patient randomized and the attention of the overall. our cash position as of today, we do confirm that this will allow Inventiva to operate until early Q3 2024. I would be glad to answer any question in the Q&A session if needed. I just pass over to Frédéric for the conclusion. Thank you.

Thank you, Jean. Before we move to the conclusion, let's open it up for the Q&A. I see that there are some questions already.