ABIVAX Société Anonyme (ABVX) Earnings Call Transcript & Summary

Good morning, and welcome to the ABIVAX Data Call on the ABX464 Phase IIa clinical safety and efficacy results in rheumatoid arthritis. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the ABIVAX website following the conclusion of the event. I'd now like to turn the call over to your host, Professor Hartmut Ehrlich, Chief Executive Officer of ABIVAX. Please go ahead, professor.

Thank you, Tara, and good morning, good afternoon, ladies and gentlemen. As Tara just said, my name is Hartmut Ehrlich, I'm the CEO of ABIVAX and, together with the ABIVAX team, I'm very happy to walk you through the exciting new data we received in our proof-of-concept Phase IIa study in rheumatoid arthritis, which clearly opens a new and exciting chapter for ABIVAX. Could we go to Slide 3, please, which summarizes ABIVAX as a company. We were founded in -- at the end of 2013 with the objective to do an IPO at the Euronext Stock Market in Paris within 18 months, which we accomplished in June of 2015, raising EUR 57.7 million, which was and still is the largest IPO in biotech on the Euronext in Paris. Importantly, while initially, we were focusing on antivirals, based on exciting data that we collected over the time when we were working through the mechanism of action of ABX464, our focus shifted with the first clinical data readout in ulcerative colitis in September 2018 to really focus on chronic inflammatory diseases. Shareholder structure, market cap is depicted on the upper right. And we have been a very small, nimble and agile company. We are now 28 employees, which clearly tells you that we are heavily dependent on the support from good R&D and manufacturing partners and just a couple of examples here. IQVIA, Evotec and, on the manufacturing side, SEQENS and Delpharm. Slide #4 then introduces ABX464, which is our lead molecule in late-stage development. It's coming from the proprietary compound library of the company, and this library was initially designed to come up with molecules that would have the ability to modulate RNA biogenesis. And ABX464, which came out as a lead compound here, is indeed a small molecule administered as an oral capsule once a day. The mechanism of action and, it's needless to say, is first-in-class and novel and is centered around the selective up-regulation of the anti-inflammatory microRNA miR-124. Now being in the clinics since 2014, ABIVAX has -- ABX464 has been administered to more than 850 patients and volunteers, and we always observed a good safety profile for the compound and, of course, a strong short- and long-term anti-inflammatory effect was confirmed previously in Phase IIa -- Phase IIb studies in ulcerative colitis and, now, of course, in the Phase IIa proof-of-concept impaction study in rheumatoid arthritis. And as a consequence, the start of the Phase III in ulcerative colitis and Phase IIb in Crohn's disease is planned for the end of 2021 and a Phase IIb study in rheumatoid arthritis. Now that we have the data of the Phase IIa, it's foreseen for early 2022. If you see the numbers on the side, then I don't need to talk about any more of the commercial opportunities for novel and safe, efficacious drugs for inflammatory diseases, just to say rheumatoid arthritis alone. Currently in the G7 countries for second and third-line treatment of rheumatoid arthritis is seeing a spending -- pharmaceutical spending of more than $20 billion. That gets me to Slide #5. It summarizes the novel mechanism of action, which I mentioned is centered around the potent and very specific up-regulation of miR-124, which almost works like a physiological break of information. In general, miR-124 works as all microRNAs, meaning by down-regulation of the translation of their respective target genes. And we get to miR-124 in a really unique way that was discovered about 2 or 3 years ago. So once ABX464 binds to its molecular target, the cap binding complex, the cap binding complex becomes able to perform one additional activity over what it's typically doing. And this is -- it is lysing a long non-coding RNA, which has the sequence of miR-124 embedded. And it is exactly splicing this miR-124 sequence out, which becomes available to then block the translation of molecules like MCP1, a monocyte chemoattractant protein STAT3, which leads to a reduction of IL-6, IL-17 and TNF alpha. The IL-6 receptor, which also leads to a reduction of IL-6 and TNF alpha. And the effect on STAT3 is not only limited to proteins, but what we are also seeing is a strong reduction of TH17 cells. So that is the background. And now I'm going to present to you the topline results and a summary, which is very similar to our key bullet points in the press release that was issued earlier this morning. So essentially, the primary endpoint of this study and that was safety, as you always have it in a Phase IIa study. So the primary endpoint was met with ABX464, demonstrating good safety and tolerability with 50 milligrams once daily oral administration. However, above and beyond safety, we also saw a statistically significant difference. The p-value was smaller than 0.03, so 3% level. That was met on the key efficacy endpoint ACR20. And I want to stress here that ACR20 is, according to current FDA guidelines, going to be the primary endpoint -- the primary efficacy endpoint in subsequent studies and specifically, if we are going forward towards NDA, that's the endpoint that the FDA wants to see. So we are seeing this difference in the protocol population with 60% of ABX464 patients dosed with 50 milligrams reaching that endpoint versus 22 in the placebo group. In addition, other key efficacy endpoints, the ACR50, 70, DAS28-CRP, CDAI and biological markers like CRP, miR-124, IL-6 showed favorable differences with 50 milligrams of ABX464 over placebo. So ABIVAX is now preparing to start a clinical Phase IIb program in rheumatoid arthritis, as I mentioned, in early 2022, with doses that are most likely 50 milligrams, 25 milligrams and 12.5 milligrams once daily, which is identical to our plans in ulcerative colitis for Phase III. And also, I think importantly, given the demonstrated safety and efficacy now of ABX464 in 2 indications -- in 2 independent indications in rheumatoid arthritis, in the joints and ulcerative colitis in the colon and rectum. So it is probably not a surprise that we are going to explore additional programs in chronic inflammatory indications. Before we go into the clinical data, the details of the clinical data that I just summarized, I just wanted to give you a quick reminder how the rheumatoid arthritis program started with the data we got from preclinical pharmacology. What you are seeing is the collagen-induced arthritis model, where the animals were injected at week 9 and at week -- with collagen and at week 12 with collagen and ABX464 with subsequent monitoring of the joint size, of the joint swelling. And as you can see in the inserted graph, clearly in contrast to the model where the animals were given just water in the presence of ABX464, there was a clear reduction of the joint circumference, which was actually highly statistically significant. So that was the start of the program. And then we went into the -- while we, of course, are continuously working on the mechanism of action, we were going into the proof-of-concept Phase IIa clinical trial. And as you can see, important here, the study was randomized into 3 groups, 1 to 1 to 1, with patients either receiving 50 milligrams once a day, 100 milligrams once a day or matching placebo for an initial induction period of 12 weeks. And following the first 12 weeks, patients could then move on with the maintenance study with a fixed dose of 50 milligrams once a day. And as I mentioned before, clearly, primary endpoint was the safety profile. So Slide #9 summarizes the topline results. And clearly, although the study was not powered for efficacy, I cannot say that often enough, we saw already a very strong efficacy signal observed with the 50-milligram dose. The patient characteristics for this study were well balanced. 70% had -- between the treatment groups or treatment arms, 70% in the past had an inadequate response to methotrexate, 30% had an inadequate response or intolerance to TNF alpha inhibitors. And in order to summarize what we are seeing here is already the statistically significant difference on the ACR20 in the protocol group with 50 milligrams. What you also see here is that when it comes to early discontinuations of dropouts, we had 1 dropout in the placebo group. We had 3 dropouts in the 50-milligram group. And we actually had 12 dropouts, so a higher level in the 100-milligram group. And to say it right upfront, I think I mentioned it before, we are not moving forward with the 100 milligrams in RA because we believe that giving both methotrexate and ABX464, we may be dealing with sort of a similar side effect profile that may be additive or even synergistic. We are very happy that the efficacy readout was not limited to the ACR20. You saw the results for ACR50 and 70 before. And on this slide, we are also seeing that the results that we were seeing in the American College of Radiology that they were actually confirmed by the DAS28-CRP and also the CDAI, as you can see yourself in the table. And also we were seeing in the blood of the patients decreased levels of IL-6 in the 50-milligram and the 100-milligram ABX464 groups and also not surprisingly, as we've seen that constantly in patients, whether these were volunteers, HIV patients, ulcerative colitis patients, the statistically significant upregulation of miR-124 in actually both study groups compared to placebo. But as I said before, primary endpoint was safety. And we did not see in this study any new safety signal that would have been reported for ABX464 plus methotrexate. You see it when you look at the serious adverse events, you see it from the fact that we are not reporting any new safety signal and an increased incidence of adverse events was reported, as I mentioned, in the 100-milligram treatment group. These were mainly GI adverse events, so gastrointestinal, as you will see on the next slide, which were leading to early study treatment interruption in that dose group, that, as I said, is no longer considered for Phase IIb or Phase III in ulcerative colitis but also rheumatoid arthritis. Next slide, please. This is a sort of listing the most frequent observed adverse events that were reported from the study. And as in ulcerative colitis, this profile is centered around 3 organ classes, infections and manifestations. However, as you can see, there's no difference between the active groups and placebo, certainly with respect to the 50 milligrams. Gastrointestinal disorders, as I mentioned, there is a slightly increasing incidents with those, which led to the elimination of the 100-milligram group for further development. And when you look at the nervous system disorders, this is typically a headache. And also here, if we look at the delta between placebo and ABX464 at 50 milligram, then we are clearly at the same level where we were before in our ulcerative colitis studies with respect to safety. I only wanted to mention in addition that also, if we are looking at lab values, we are not seeing any abnormalities. No liver function test increases. No anemias. No reduction of white blood cells, be that neutrophils, be that lymphocytes, which, again, is very consistent with what we have been observing with the molecule in the indication ulcerative colitis. So what are the next steps going to be over the next couple of weeks? We will complete the evaluation of the induction study and collect all the data that has made available and also especially the additional statistical evaluation. So far, we have only looked for the topline data at the ACR20, and we've been talking about this result. But now we are looking into all additional comparisons to give us an idea of what's going on. We are also continuing with the 2-year maintenance study with the objective to be able to release the 1-year maintenance data in Q1 of next year. And then, of course, the initiation of the next clinical studies, it will probably at least be 2 studies in patients, first of all, with inadequate response to conventional DMARDs, but then also in patients, that failed to or were intolerable to biologics, and that study should start in Q1 of next year. And then as my last slide, before we are going into the discussion, I just wanted to briefly show you the very attractive target market that rheumatoid arthritis is for drug development. And especially as per very recent paper that we actually quoted in the press release, around 75% of patients on treatment these days are not happy with the current drugs that they are on. And what you see here, if you drill the roughly 27 -- sorry, 26.5 million cases of patients with rheumatoid arthritis worldwide. If you drill this down to our target population and a population where we have somewhat reliable commercial forecast numbers, and these are patients with moderate-to-severe disease in the G7 countries, who are treated with second and/or third-line therapies, then we are down to 730,000. And importantly, as I said, that translates to the very large market that we have been discussing before. And so with this, I hope that the presentation was not too long and was understandable. But as we mentioned before, now we are here ready to take your questions. Thank you very much.

Thank you, Hartmut. At this time, we'll be conducting a question-and-answer session moderated by Chris Maggos of LifeSci Advisors. [Operator Instructions]

Thank you, Tara. I currently see no questions. I'm just refreshing. Here they are. Okay. First question from David [ Senage ] from Degroof Petercam. Does the outcome of this Phase IIa in RA change anything about the design of the IBD studies?

That's a question for...

Paul Gineste speaking. So good question. Basically, we do not envision that this readout of the IIa study in rheumatoid arthritis will change something in the current Phase III design. We are currently working on with IQVIA and with regulators.

So next question from Chris Redhead at goetzpartners. Ulcerative colitis Phase IIb study showed little difference in adverse events for 25 milligrams. Why are you intending to test 12.5 milligrams?

I'm not sure I totally understand the question. Our rationale to include the 12.5 milligrams is that we want to make sure we get to a lower dose because we do realize that with the 25 milligrams, we have not reached a point where the efficacy is falling off. And we just want to make sure that we treat the patients within as low dose as possible.

From David at Degroof Petercam. Can you remind us why you do not observe a dose response effect considering that you observed similar up-regulation of miR-124 when it's administering both doses?

There, again, it's a very good question. Basically, our current thinking about why we are not observing those effects on the efficacy side for ABX464 is related to [ a small upregulation ] of 464. We have been demonstrating, and we will communicate those results when they become available. But we do observe an upregulation of miR-124 in all patients. We are waiting for the Phase IIb study and especially the dose range we were testing in ulcerative colitis to see whether there is a dose effect on the up-regulation of miR-124. But our feeling is that even at a very low -- at a low level and low magnitude of the upregulation of miR-124, you have already an effect -- an efficacy effect. And you can increase further this upregulation, you're not going to change because by nature, the miR-124 mode of action is to get rid of the excess of the pro-inflammatory cytokine that are secreted or translated. So this is [ 2 words ]. Currently, this is clearly related [ at the median section ] and basically support the novel mechanism of action of ABX464.

Maybe in the same vein, it's an anonymous question. But can you please talk more as to the reasons for the 3 discontinuations in the 50-milligram arm? Were these owing to GI AEs, also?

Yes. So in the 150-milligram arm, we have 3 discontinuations. There is one which was due to abdominal pain -- upper abdominal pain and 2 were for patients who withdrew consent.

A more general question from Chris Redhead. How do these results compare with current therapies?

We have been discussing this with some of our key opinion leaders in the field. And what we can say at this point in time is based on the feedback that this compares very favorable with data that is out there. This is a very encouraging Phase IIa outcome and should really urge us to move into later-stage development as quickly as possible because it really looks like ABX464 is not only a competitive development compound in ulcerative colitis, but in a similar way in rheumatoid arthritis.

Back to specifics. So Samir Devani from Rx Securities asks, you had 6 patients excluded for protocol violation in the 50-milligram group, 3 discontinued early. What was the reason for the other 3?

Can you repeat the question, please?

Yes. I'm not sure I understand it myself. So you had 6 patients excluded for protocol violation in the 50-milligram group, 3 discontinued early. What was the reason for the other 3?

This is -- again, this is a good question when you are looking at the numbers. Basically, the 3 other patients were removed from the per protocol because it was not possible to compute. I don't know whether you are familiar with the ACR endpoint, but it's a 7 dimension index, gathering or embedding the CRP, the swollen, the tenderness of the joint and joint swelling and also the different pain scales and so on. So if we are missing only one of those sub score. We are unable to compute the total ACR score, and this is the reason why. There is no safety issues. This just a matter of the completeness of the data that has made those additional 4 patients out of the per protocol.

Okay. Thank you. Related to that, Bertrand Delsuc from Biotellytics is asking, is the observed benefit particularly driven by one component of the ACR20 score?

Good question. We just got the topline results. And so we are going to look at that. But at first glance, it seem that all dimension of this year are going into the same direction. So the biological CRP marker as well as the [ fecal ] score.

Okay. Again, another question from Bertrand. There was a lot of discontinuation with the 100-milligram dose of ABX464 on top of methotrexate. If I'm correct, methotrexate is also used as a background therapy in ulcerative colitis. Can you tell us if you saw a particularly high discontinuation rate in patients under methotrexate and treated with 100 milligrams ABX464 in the Phase IIb ulcerative colitis trial?

Yes. Again, good question. But while the methotrexate is well used in rheumatoid arthritis, this is a drug that is no longer used in ulcerative colitis. For instance, we got only one patient that had been concurrently treated with methotrexate in our last large-scale Phase IIb study. So methotrexate is no longer a drug that is used in that. So -- and just to complete my answer, we are going to do some [ preclin ] analysis for 464 and also methotrexate, just to see whether we need to adjust the dose of methotrexate in our upcoming studies.

Last question from -- for now from Bertrand is outside of IL-6 and CRP, are there other cytokines of interest where you saw immunomodulation?

We are looking at other cytokines, but we don't have the data at this point in time.

Maybe a more general question. What will the -- this from [ Mathias ], a private investor. What will be the USP of ABX464 compared to other drugs in treatment of UC and RA?

I think we mentioned before that there is a high rate of patients that are unhappy with the treatments that they are currently on. And you can ascribe that to either lack of efficacy or of the appropriate efficacy and you can then ascribe that to lack of safety. I think we all know that for some of the drugs currently use, the potential side effects are very, very severe. For ABX464, number one, it is an oral drug; number two, it is a drug with a -- based on almost 1,000 individuals that did receive ABX464 that is well tolerated. We also see the efficacy, which, of course, we need to quantify further going forward. But importantly, the molecule has a different mechanism of action. And I think this is largely what is being looked for by the community considering the many, many patients that are either not responding from the beginning or after an initial response, failed to respond over time. And I think as we are developing this molecule further, we will learn much more about it in this particular indication. But I think in general, as we have been outlining for ulcerative colitis, this is a molecule that has the potential to really establish itself in this indication based on the [ USPs ] that I mentioned before.

So that leads nicely into this next one from Andreas Bischof from Nova Funds. Why not use ABX464 as a first-line treatment?

That is, of course, a nice suggestion. But as we all know, the situation is relatively similar to the situation in the inflammatory bowel disease where older generic type drugs have really taken the stage. And for one argument, I can certainly assure you that we are not interested in competing on price with generics from the beginning. But it's more like our strategy in inflammatory bowel disease, where you are seeing most of these patients failing after a relatively short period of time and then comes the time for the biologics and for similar molecules for JAK inhibitors by ABX464 to take the stage in order to hopefully provide a long-term solution for these patients.

A couple of more specific questions and then there's several questions on partnering and financing, but we'll just finish these up. What can you say about the speed of the onset of action of ABX464?

We have been demonstrating in ulcerative colitis that basically the onset of action of 464 is very early on. We are currently looking at the topline results and with the -- looking at this year at week 4, week 8 and also the DAS28. So we cannot comment any further on that for the time being. But obviously, we do hope that we'll see the same pattern as in ulcerative colitis.

Which was?

Which was early onset of action.

In ulcerative colitis, just to remind the audience, we were seeing a partitioning of the placebo patients from the ABX464 treated patients when we were looking at the symptoms that we can capture early like stool frequency, like rectal bleeds, et cetera. So essentially a partial modified Mayo score, we saw the curves drifting apart as early as after 1 week. And after 4 weeks, we had a statistical difference between the placebo group and the 3 dose groups, they were essentially superimposable with a p-value of 0.001, so a 0.1% level.

So [ Vincent G ], an investor asks, you said that the 3 early discontinuations in the 50-milligram group was due to 1 GI AE and 2 patients who withdrew consent. Did you mean that the 2 consent withdrawals did not experience AEs?

Well, I don't have the details for the withdrawal consent. So one was experiencing GI symptoms. But -- yes.

One of the 2, and the other? Do we know?

The other...

Basically, I just would like to comment on this question is that the reason for discontinuation is clearly patient-to-patient consent withdrawal. In the background patient, those 2 patients did experience some side effects that were mild. Clearly -- so we don't -- we cannot figure out whether this consent withdrawal was clearly related to the experience of a very mild aversions. So for us, it's very difficult to comment at this stage.

Okay. [ Vincent ] also asked, have -- you seem to have decided the ulcerative colitis Phase III doses. Have you received the UC biomarker data already? When can we expect, one, the full topline data at 8E and the additional 16-week data in UC? I think he means 8 weeks.

Basically, as communicated previously, we do expect to have the full data set clinical readouts by the end of the month, so maybe next week from our partner IQVIA. And this be communicated early July. And for the biomarker, including miR-124 iterations, cytokines and so on, we do expect to get this result by the end of July.

Last question from [ Vincent ]. What doses are you currently testing in the TQT study and when will this read out?

Okay. For the TQT study, that is almost completed in terms of enrollment. We have 111 patients out of 120. So we are clearly close to the enrollment completion. We are testing 2 dose regimens, 50-milligram and a [ cipros ] therapeutic dose, which is 150 milligrams as per the FDA guidance and the European guidance.

Okay. And another question, I need to help translating to English. I think it's, what about [Foreign Language] How did we say that in English? It's...

Ankylosis spondylitis as far as I know.

Yes, that's it. Is that an indication that you would pursue?

Well, that is for us moving forward. As you know, there are more than 100 disease entities that qualify for being chronic inflammatory diseases. So at this point in time, I cannot exclude that. I cannot include that. We are currently really busy, especially the clinical and medical team with the evaluation of the 2 completed studies. But once this has been accomplished, we will be looking -- certainly including our preclinical team members into -- looking into different analyses as to what might be additional indications that lend themselves to ABX464 treatment.

Okay. Related, why did you change your plan to a Phase IIb in Crohn's instead of a Phase IIb/III trial?

This is basically semantics. It doesn't change the design that we are thinking about, and it also doesn't change the fact that the Phase IIb study, in our view, is going to be a pivotal trial when we talk about licensure of ABX464 in Crohn's. Just study semantics.

Sophie [ Budeaux ] from [ Financia Arbudel ] asks, you'll have to test 3 doses in ulcerative colitis Phase III. It increases the number of patients you'll have to enroll. What should be the cost of this Phase III? We're moving to the finance questions.

Yes. But we'll take that question because we got already some proposals from different partners, especially the IQVIA who is deeply involved in the design of those Phase III studies in ulcerative colitis. Overall, the clinical -- what we do envision is to run in our 2 induction study in parallel, 2 pivotal study in parallel induction and patients will be -- patients coming from -- coming out from those 2 induction studies will be rolled over into a well-controlled maintenance study worldwide. We are going to cover all countries. And the total cost for this program is around EUR 200 million.

Sorry, I've got a couple more on the clinical trial. So could you provide -- this is from Bertrand at Biotellytics. Can you provide more baseline info, CDAI at baseline, mean methotrexate dose per week, proportion of female patients, mean duration of RA, proportion of patients under steroids?

For rheumatoid arthritis, you mean? Again, we got only the topline results with -- basically, what we got is patient demographics, and this is very well balanced across the group. So in terms of age, in terms of BMI, in terms of gender, in terms of severity of the disease, you can see in the press release that patients were clearly severe patients with a DAS28-CRP at baseline. That was at 5.3% in the placebo group, 5.5. in the 50-milligram group and 5.5% in the 100-milligram group. When it comes to concomitant treatment, everything were kept stable during the course of the study. We don't have yet the percentage of patients that have been receiving some concomitant corticosteroids at stable dose. And just the proportion, the percentage of patients, who were refractory to TNF, is 30%. So 18 out of 60 patients were refractory to biological treatments. Again, this was part of the stratification, so very well balanced across the group.

One more question from Bertrand at Biotellytics. It seems the DAS score at baseline was lower than in other studies in the same population of patients with inadequate response to methotrexate. Yet, the placebo ACR20 response rate observed in this Phase IIa study is low as compared to the ACR20 rates from larger studies in this population. What are the factors that could explain this?

Well, as you can imagine, having received the results not even 48 hours ago and now following the press release and the webcast here, this is something that we are going to evaluate, but we don't have answers to all the questions yet. And this is certainly one that we are going to look at. But I think it's important that indeed the placebo rate in this particular study is lower than in many other studies with biologics and JAK inhibitors. And that's actually, I think, positive to -- with respect to comparing the severity of the diseases across studies. So as Paul just said, we believe we had a very severe patient pool in this study.

Maybe just -- I think you answered this during the presentation, but could you please just review the 3 doses for both the RA and the UC Phase III trials?

Yes. I said it during the presentation. When we talk about RA Phase IIb, going to be 12.5, 25 and 50. And if you're going to talk about Phase III, you see it's going to be 12.5, 25 and 50.

It's all same?

Absolutely.

Okay. From Sten Stovall at Informa. Any news or comments on your stated aim of reaching a transformative partnering deal now the key UC and RA data is out and positive?

For this, I'm going to leave the stage to our CFO, Didier Blondel.

Yes. Good afternoon, good morning, everyone. So how I will try to answer this partnering question is in a more global perspective, and that will also address voice of the questions that certainly would come for the financing of the company. Number one, we are funded until Q4 2021. We have always said that. In Q4 2021 and Q1 2022, we plan to have large studies starting. We plan to start the Phase III program in UC, the Phase IIb or Phase IIb/III program in Crohn's as well as -- now we can say it because we have the Phase IIa RA in clinical data in our bag. We will start the Phase IIb -- the 2 Phase IIbs in RA. So that means that we'll have an inflection point in terms of new commitments, new spending to come. Here, we're very consistent with what we have always said. It happens that now we have all the data in our hand. Our #1 priority remains partnering. So when we say partnering, naturally, it means that we want to have a partner for strategic and as well as financing reasons. We think that partnering is making sense with ABX464, addressing so large unmet needs and huge commercial opportunities where a partner, a large partner would take care of ABX464 in a very effective way in the future. So partnering remains our preferred option. And we always said and we already said that partnering, there is a wide range of opportunities when you talk about partnering and that for us, with 90% or more of the value of the company being in ABX464 a #1 asset, this could lead to an M&A, and our Board of Directors is not against this idea. So that's for partnering. And obviously, we cannot comment the status of partnering discussions. That's something that is naturally confidential, but having accumulated those nice clinical data will certainly help to have speed and good discussions with potential partners. However, in parallel to this option A, we want also to be ready for all options. And we're also preparing the company to continue by itself -- get organized by itself and making sure that we can have the funding in place beyond Q4 2021 to continue the development program of ABX464. This we are considering the various options that are open with this financing, and that's naturally something that we are looking at. And what we can just say is that now that we have the RA data in hand, that will definitively help us to speed up our thinking and our, let's say, efforts or discussions and that -- all this will be done with one priority, creating shareholder value.

Didier, could you maybe just comment on -- with the cash that you have right now, what are the next plans in the coming months in terms of continuing development? Could the partnering activity or the financing be a bottleneck in terms of moving forward the product?

Yes, I was trying to explain this that we have the 2 options in parallel. Naturally, we will continue and boost our partnering discussions. But definitely, our priority is to continue to develop ABX464 in the most effective way. And so we're getting organized as well by ourselves to boost our efforts in that front.

Very good. And I think it's going to be the last question. You covered most of these questions on financing and partnering that are here. Could you make a short review of the IP, or intellectual property, for ABX464? It's from Bertrand at Biotellytics.

Sure. So the patent of composition of [ matter ] have been filed in 2010. So [ relevant to ] 2030 with some possible expansion in different countries and the patent for the use in inflammation and broad inflammation has been filed in 2015, so run until 2035 with also possible extensions.

And it's wholly owned by ABIVAX?

Yes.

Very good. I think with that, we have covered all the questions. I'll turn it back to you for closing remarks. Congrats on these amazing data.

Okay. Thank you. I started to speak while I was on mute. So thank you, Tara. Thank you, Chris, for walking us through this webcast. I hope that the level of excitement that these data were causing in the ABIVAX team are shared in the community. They are certainly shared with some of the KOLs that we are working with. And as you said, we are now working in parallel on moving the development of our compounds forward, which is largely putting together the clinical trial protocols, et cetera, for the ambitious program that we are having ahead of us. And secondly, on the financing, really complete the steps that Didier has been outlining. So we are really looking forward to drive ABX464 forward. And certainly, just RA, if we look at the numbers, the pharmaceutical sales on this indication, that essentially just doubles the opportunity for ABX464. And this is a good position to be in. Thank you.