Poxel S.A. (POXEL) Earnings Call Transcript & Summary

Hello, everyone. Welcome to Poxel's Half Year 2021 Results Presentation. [Operator Instructions] Thomas, I give you the floor.

Thank you very much, and thank you for joining us today. I'm Thomas Kuhn, I'm the CEO of the company. After my introductory comments, I will hand the call to Anne Renevot, our CFO, to review the first half 2021 financial results. And then David Moller, Chief Scientific Officer, will provide an update on our clinical pipeline. Before we begin, this is our forward-looking statements. Just to remind that forward-looking statements are subject to inherent risks and uncertainties beyond the company's control that could cause the company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. Further information can be found in our most recent regulatory filings. So as some of you know, Poxel's mission and vision remain to discover, develop and commercialize innovative therapies for patients suffering from serious chronic diseases and rare diseases with underlying metabolic pathophysiology. Congratulation to our highly experienced team in the metabolic disease field, which achieved our first product approval in June for Imeglimin, now launched and marketed as TWYMEEG in Japan. Following this success, we announced a new strategic direction, which align our vision and mission with a faster-to-market strategy in rare disease. We increased our focus on rare metabolic indications that represent the intersection of high unmet medical needs, preclinical and clinical data, opinion leader enthusiasm, significant commercial opportunity, and attractive time horizon. We are now very focused on NASH and rare metabolic indications, starting with adrenoleukodystrophy with the aim to advance into clinical trials, one program in NASH and one program in ALD. The approval of our first product in Japan, followed by the product launch by our partner last week on September 16, opens a new chapter for Poxel to drive shareholder value. With additional funding from TWYMEEG, we are investing these funds to accelerate and expand our clinical pipeline of rare metabolic disease programs. By developing products in rare metabolic disease in addition to NASH, we can be more efficient with our resources and more exponentially deliver novel medicines to patients with even stronger potential to create significant value for the benefit of our shareholders. As you can see in this chart, this is our pipeline. It is a well-diversified pipeline in terms of indications, clinical stage and risk profile. David will walk you through, sorry, our development plans for NASH and ALD and how this can position us to be potentially initiating pivotal trials in ALD in 2023. Our clinical pipeline continues to advance. Earlier this week, we announced the completion of the enrollment in the PXL065 Phase II DESTINY-1 trial with 123 biopsy-proven patients enrolled. We look forward to the result in roughly a year from now in Q3 2022. We also intend to further strengthen our existing metabolic pipeline with additional internal and/or external opportunities. We specifically have next-generation compounds from our existing platform technologies that could reach clinical stage in the near-term horizon. The TWYMEEG approval and launched in Japan represents a major milestone for Poxel and the culmination of several years of clinical development work. This is a strong validation of our R&D capabilities and the international footprint that we have established. The approval in Japan allow Poxel to receive EUR 13.5 million of the third and final tranche of the IPF loan in June and EUR 13.2 million milestone payment from our partner, Sumitomo, in July. Sumitomo, who is the market leader in Japan for type 2 diabetes launched TWYMEEG last week on September 16. Based on our current forecast, Poxel is entitled to future potential sales-based payments of up to approximately EUR 200 million as well as escalating double-digit royalties. We believe that TWYMEEG is an important addition to Sumitomo existing number 1 diabetes franchise through its differentiated mechanism of actions, targeting the 2 defect of diabetes, including favorable efficacy and safety program. Based on the clinical data obtained in Phase II and Phase III, we believe that TWYMEEG has the potential to be used as a monotherapy alone as well as in combination with other products, specifically complementing well Sumitomo existing infrastructure in type 2 diabetes. This approval of TWYMEEG provides patients with type 2 diabetes the opportunity for greater flexibility in their treatment. As mentioned earlier, we really want to expand and further strengthen our clinical pipeline of rare metabolic disease programs as it represents the intersection of high unmet medical need, preclinical data and a clinical data, opinion leader enthusiasm, significant commercial opportunity and attractive time horizons. Particularly, this market opportunity for rare disease is highly attractive due to premium pricing supported by prior orphan drug approval. And Poxel has the ability to commercialize on our own, which would allow us to capture greater economics. We believe that Poxel is well equipped to be a leader in this field, given our exciting programs and our capabilities. I will now hand over to Anne, our CFO, to go through the 2021 H1 financial statements. Anne?

Thank you, Thomas, and good evening, everyone. So I will now review our financials for the first half of 2021. So let's start with revenue on Slide 9. Poxel reported revenues of around EUR 13.3 million for the first 6 months ended June 30, 2021, as compared to EUR 6.4 million during the corresponding period in 2020. This revenue mostly reflects the JPY1,750 million milestone payment from Sumitomo Dainippon Pharma triggered by the [ general ] marketing approval of Imeglimin in Japan. The payment was received in July. So turning to Slide 10, which is a statement of comprehensive income. So as a preliminary relaunch as a biotech company, the majority of Poxel resources are allocated to research and development activities. Net R&D expenses amounted to EUR 14.7 million for the first half of 2021 as compared to EUR 12.6 million for the corresponding period in 2020. R&D expenses for the first half of the year primarily reflected the clinical study costs incurred for Phase II DESTINY-1 study evaluating PXL065 in NASH. To a lesser extent, they also reflected some Phase IIa clinical program residual cost of PXL770 for the treatment of NASH and also the regulatory costs incurred over the period for Imeglimin, for which the company obtained marketing approval in June. As a reminder, R&D expenses are net of the R&D Tax Credit that resulted in an income of EUR 1.5 million for the first half of year, which is the same level for the first half 2020. General and administrative expenses amounted to EUR 5.4 million for the first half of 2021 compared to EUR 6 million for the first half of 2020. The financial loss amounted to EUR 1.2 million for the first half of 2021 as compared to an income of EUR 0.2 million for the first half of 2020. This loss primarily reflected the interests attached to the company indebtedness. The net result for the financial period ending June 30, 2021, was a net loss of EUR 8 million as compared to a net loss of EUR 12.1 million for the corresponding period in 2020. So moving on to Slide 11, with net assets. Two points. First one is the trade receivables that amounted to EUR 13.3 million at June 30, 2021, compared to EUR 0.3 million at December 31, 2020. This reflects the marketing approval milestone for Imeglimin in Japan that was accounted for at June 30, 2021 and paid in July. Cash and cash equivalents amounted to EUR 36.9 million at June 30, 2021, compared to EUR 40.2 million on December 31, 2020. The change in cash for the first semester amounted to 3 -- minus EUR 3 million, reflecting EUR 13 million coming from financing activities and minus EUR 16 million coming from operations. So moving along to Slide 12 with the shareholders' equity and liabilities. So the shareholders' equity amounted to EUR 21.6 million for the first half of the year compared to EUR 26.9 million at December 31, 2020, which mostly reflects the half year 2021 net loss. The financial liabilities amounted to EUR 37 million compared to EUR 24 million at December 31, 2020, mostly reflecting a EUR 30 million loan with IPF and a EUR 6 million loan with PGE loan. Last comment, the litigation with Merck has been settled, and the current provisioning has been fully reversed accordingly. So turning to Slide 13 with the statement of cash flows. So as previously explained, the cash flow from operations activities amounted to minus EUR 16.1 million for the first half of 2021 compared to EUR 14.5 million for the first half of 2020. This included the half year 2021 net loss and also a EUR 10 million change in working capital, which mostly reflected the EUR 13.2 million milestone payment that was received as part of the marketing approval for Imeglimin in Japan and recorded at the end of June 2021 paid in July. The cash from financing activities amounted to EUR 12.8 million for the first half of 2021 compared to EUR 23.2 million for the first half of 2020. This mostly represents the drawdown of third tranche of the IPF loan for the amount of EUR 13.5 million. So moving to Slide 14. Thank you. We have listed the relevant shareholder information as well as our research coverage in both Europe and the U.S., which includes 5 companies: ODDO, Bryan Garnier, and Degroof Petercam in Europe; Jefferies in U.K.; and JMP in U.S. So I will now hand over to David to provide our clinical programs.

Thank you, Anne. It's my pleasure to now provide you with an update on our R&D activities. Starting with our advance into rare metabolic disease with our existing platforms, the deuterium-modified TZD and AMPK activator small molecules. So let me first summarize some of the key features of our 2 lead molecules. PXL065 is the deuterium-stabilized R-stereoisomer of pioglitazone, a widely prescribed medicine for type 2 diabetes, but unlike PO, 065 lacks significant PPAR gamma activity and mediates its efficacy via non-genomic TZD related pathways such as modulating the mitochondrial pyruvate carrier and inhibition of acyl-CoA synthase 4 Strong efficacy has been documented in several preclinical disease contexts, including NASH and ALD, but without PPAR-gamma side effects like weight gain and fluid retention. And given its relationship to PO, the 505(b)(2) regulatory pathway in the U.S. can be employed, leveraging a large safety database for the parent compound. More than 130 humans have been exposed to PXL065 per se and the expected clinical safety has been validated, and we've also shown that selected dose proportional exposure to the preferred isomer, the R-isomer translates into humans. PXL770 is our novel direct AMPK activator, the first such molecule to be studied in any human disease. In preclinical models of several diseases, it exerts substantial efficacy. Clinical development to date has demonstrated target engagement and translation of several diabetes and NASH-related efficacy parameters to humans, suggesting the likelihood of broader translation for this mechanism. Preclinical and clinical safety have also been established with favorable safety profiles in more than 200 humans exposed for up to 12 weeks. Now let's move on and talk a bit about adrenoleukodystrophy, X-linked adrenoleukodystrophy, or ALD is a monogenic inborn error of metabolism due to mutations in the ABCD1 gene, which encodes a key cellular fatty acid transporter. This defect results in accumulation of very long chain fatty acids, VLCFA, with damage to several tissues, in particular, neurons. As an X-linked disease, males are more severely affected, but many females are as well. ALD is increasingly being diagnosed based on the recent and broad-based adoption of newborn screening. Thus, the prevalence of ALD is similar to that of hemophilia or spinal muscular atrophy, about 20,000 patients in the U.S. alone. This slide provides a high-level view of ALD pathophysiology. As I mentioned, increases in VLCFA, specifically saturated C26 fatty acid, are the primary driver of disease with downstream pathologies leading to axonal degeneration for both cerebral and spinal cord forms of disease. Importantly, multiple recent publications support the utility of both AMPK activation and TZD-related pathways for the treatment of ALD. And we have developed evidence to show that both of our platforms, AMPK activators and D-TZDs can be leveraged to address this pathophysiology to correct the primary defect by suppressing VLCFA levels and by potentially ameliorating downstream consequences that include mitochondrial dysfunction, inflammation and cell death. Over the course of the last year, we've carefully studied both of our lead molecules in classical ALD preclinical models. These include patient-derived cells and the ABCD1 null mouse. And data that are not shown on this slide, we observe that both compounds produced substantial reductions in VLCFA, both in vitro and in vivo, including in brain and spinal cord. In more recent experiments shown on this slide that we're also conducted using the ABCD1 mouse, we observed evidence of improved neural histology and neuro behavior with both PXL065 and PXL770, and some examples of these data are shown here. In the images on your left and accompanying graph, you can see that distorted axonal morphology is improved. In this case, by PXL065 and pioglitazone, we will be also seen similar effects with PXL770. On the right, our quantitative results have balanced of coordination using a balanced beam test. And here, we see that the disease mice exhibit in impaired performance versus wild-type mice, and the treatment with PXL770 was able to reverse this defect, a similar profile also seen with PXL065. Based on all the preclinical and clinical data we have for both platform leads, we now plan to initiate 2 parallel and identical Phase IIa biomarker-driven POC studies, one with PXL065 and one with PXL770. The study design was developed with substantial input from several disease experts in the U.S. and Europe. Each trial will enroll approximately 12 adult male patients with the most common subtype of ALD AMN. Following a run-in period, patients will be treated for 12 weeks with a single oral daily dose of either molecule. Readouts will include PK, safety and measurements at several time points of key disease biomarkers, VLCFA and neurofilament light chain, both of which are validated as disease associated. Additional exploratory biomarkers will also be assessed. These trials are expected to begin in early 2022 with data available later that year. And following analysis of these results, we should be able to choose the preferred molecule for further advancement into a pivotal trial to begin in 2023. We intend to finalize our Phase III plan with regulatory agencies and further discussions with experts and also with patients. Depending on treatment duration and the final selection of endpoints, our pivotal trial could lead to an NDA filing in 2025. In summary, we're very excited to pursue treatments for ALD as this represents an area of very high unmet medical need due to a lack of current therapies. It also provides a substantial commercial opportunity given premium pricing for orphan drugs with similar prevalence, and we can expedite clinical development. The ALD community is very engaged with us, and we've established relationships with key opinion leaders and collaborations with important patient advocacy groups. Now let me briefly summarize our progress in NASH. Given the unmet medical need, given that there are still no treatments available for patients, we believe that our innovative approaches with both PXL770 and PXL065 enable Poxel to have a significant role in this area. In addition to strong preclinical data in ALD, both PXL770 and PXL065 have evidence to support their development for NASH. Clinical validation exists for both. For PXL065, a wealth of clinical data in NASH with the parent molecule, pioglitazone has demonstrated substantial efficacy, at this point in 6 independent trials. For PXL770, our recent Phase Ib and Phase IIa results have also yielded prominent efficacy signals; both are first-in-class and both are daily oral approaches. An innovative development approach can also be pursued for both molecules as well. As we announced last week, our PXL065 Phase II study, DESTINY-1 is now fully enrolled and will yield results approximately 1 year from now. By leveraging the 505(b)(2) regulatory path, we designed a streamlined single Phase II study with 3 closely separated dose levels. Based on Phase I data and PK/PD modeling, the 15-milligram dose is predicted to achieve the efficacy equivalent of 45 milligrams of pioglitazone without significant weight gain or edema. Results from this trial will enable the selection of 1 or potentially 2 doses for advancement into Phase III. With PXL770, we demonstrated good safety and tolerability in humans as well as having established target engagement. In the most recent trial, the STAMP-NAFLD Phase IIa study, we showed evidence of efficacy with respect to both NASH and diabetes-related parameters and a substantially greater response for all parameters in patients with fatty liver disease who had co-existing type 2 diabetes. This finding may relate to literature showing that endogenous AMPK activity is suppressed in the context of hyperglycemia or other aspects of metabolic dysfunction. As Thomas mentioned, our newer strategy includes first evaluating the potential of PXL065 in NASH and the assessment of both PXL065 and PXL770 in ALD before considering the further pursuit of PXL770 for NASH. I'll now turn the presentation back over to you, Thomas, to conclude.

Thank you very much, David. Over the next 12 to 18 months, as you have understood, we have a number of near-term milestones to drive, sorry, the growth, including the readout from the PXL065 DESTINY-1 Phase II trial in NASH, for which I believe give you a bet as well as the 2 proof-of-concept biomarker studies for the treatment of adrenoleukodystrophy. So to summarize on the launch of TWYMEEG in Japan opens a new chapter for Poxel and provides a future funding stream to Poxel that we are willing to invest to accelerate and expand our clinical pipeline in rare metabolic diseases, first, leveraging our internal platforms. We are very excited that our new strategic direction with an increasing focus on rare metabolic disease in addition to NASH has the potential to deliver significant value to shareholders as we turn over [indiscernible] on multiple Phase II studies in 2022 that may allow us to initiate pivotal trials in 2023. With that, we look forward to updating you on our progress. I'd like now to thank everyone for your attention, and we can now open the Q&A session. Thank you very much.

[Operator Instructions] So we have Lucy Codrington who would like to have the floor.

And just a couple for me. So I was wondering if it would be possible to provide a little more detail on your commercial expectations for TWYMEEG and particularly in light of the MHLW sales prediction. I understand that MHLW is traditionally very conservative. But even if I were to double it, it still seems quite light compared to my forecast. And if we were to use Equa sales for context, how do you view TWYMEEG compared to Equa's commercial performance so far, excuse me? And secondly, it seems to me you could end up in a conundrum in which the PXL065 data looks better for ALD. But you end up also having very strong NASH data, whereby the part to market and the potential addressable population in NASH are arguably bigger for PXL065 than PXL770. And how would you potentially manage that situation? I know it will be a good situation to be in, but kind of how would you view that then? And then finally, if it's possible, could you give a rough guide to the cost of the ALD studies or -- and/or your projected cash runway now that you're going to be conducting the ALD trials? Thank you.

Thank you very much, Lucy, for your question. So let's start maybe with Imeglimin. So in terms of forecast, so I mean Sumitomo has not given any official forecast there. And so, it will be difficult to answer these questions. But there is, however, a number of elements that basically we can share with you. Just to recall under the consensus of analysts, I mean, not only you, Lucy, most of the analysts or all of our analysts now really have in mind that the product we need to deliver between [ $200 million and $230 million ] sales for Imeglimin or TWYMEEG in Japan, which we believe is the right number. To come back to your question, the MHLW report that you've seen now has basically been generated in the context of the pricing discussion for TWYMEEG in Japan. And of course, as you can imagine, it's a very conservative approach here. One element that you need to be in, specifically the low patient base that has been included in this report. As we all know, there is a significant higher number of patients in Japan between basically 8 million to 9 million patients overall. So I think what you have in your model, we believe it's still really something that we believe we could target because, again, we demonstrated very strong profile for Imeglimin. Sumitomo is the #1 really player in diabetes in Japan with the largest sales force, [ 800 ] in sales force. They have been very active lately executing the market and really setting up the floor really for the launch of the products there. To come back to another piece of -- to your questions. And it's so interesting, it's what I just mentioned. As you said, Sumitomo, they have 5 products on the portfolio for diabetes, including Equa. You might have seen that for the last year, they disclosed that basically they nearly generated close to $900 million really for the old franchise. Equa is a major contribution to it now, so between EUR 350 million to basically around, let's say, a $250 million overall. We believe this is very interesting vis-a-vis Imeglimin. Given the profile of Imeglimin, as we've said, given what we've shown in the Phase III, Sumitomo is in line, of course, to combine Imeglimin through any product available in Japan, starting with DPP-4 inhibitor, so including Equa, of course, as you can imagine, we know that the DPP-4 inhibitor is the largest prescriber treatment in Japan. And of course, that will help to really ramp up the uptake of Imeglimin on the market. But also, what's interesting is that very earlier now and that's unique in Japan, Sumitomo will have the opportunity to basically broaden the patient base and target really monotherapy indication and even the first line indication. And we believe that this could occur really in the near future. As a reminder, we showed very robust efficacy of Imeglimin during our Phase III trial, with close to a minus 1% [indiscernible], very good safety. So that's why on all these basis, we remain very excited about the potential of the product. We believe that what Sumitomo is doing with Equa would reflect well what they could do as well on Imeglimin. And so, that's why we remain really bullish on what really Imeglimin could deliver as a sales engine. So that's really related to your question on TWYMEEG. Going back to your question in -- really on the strategy more and the platform, so you are right [indiscernible] we remind that our platform, whether this is the AMPK activation platform or the deuterated TZD platform, have a strong potential in various indications. And the example that you took, Lucy, could be the right one, where basically PXL065 could deliver very good results in both ALD in the upcoming Phase II as well as in NASH in the DESTINY trial there. Just to mention things are just 2 readouts will be available pretty much on the same time with the readout 3 and the readout really for ALD better in Q4. And so, the goal will be, as we mentioned earlier, to really continue and push forward 1 program into the pivotal program for ALD and 1 really for NASH. And what we have in mind to be clear is that the same products cannot be really progressed in these 2 very different pathology. For obvious reason, we all have in mind, of course, the price difference between rare disease and NASH, but they are much more reason to be. So that's why if that's occur. And as you said, it will be a good program to have, to have the same product really having really positive and robust results really for 2 very different indications. That's where developing our next-generation compound could be very important. We have ongoing efforts on this. And the goal will be to bring a new candidate for development in the near future, so that it's really 1 platform delivered the best results for 2 different indications. We'll have the ability to select the lead assets for 1 indication and then to push the next-generation compound for the other indications there. I don't know, David, whether you want to elaborate on this.

I think that's a good point. Of course, the PXL770 also has strong potential in ALD, and we could be in a situation where we might have PXL065 going forward for NASH and choose to focus the ALD indication with PXL770. That's another scenario. That would be the best case scenario, perhaps.

So I hope that answers your question. So your last question on the cash runway. And so before leaving the floor to Anne, just to put release some figure there. One -- I think one of the interests answers your question of this rare diseases' strategy is that, of course, in contrast to NASH and diabetes, which require hundreds and hundreds of patients in the studies. In rare disease, of course, there will be a much more limited number of patients there. So as you see there are 2 proof-of-concept studies that we plan to do, it will be of 12 patients each. So that's a very limited number of patients. And so, that's a few million dollar investment for each study. So not a lot of investments compared to other disease. And then going forward, of course, we are working on the confirmatory program. But again, we have in mind that for ALD, and we have already an interesting discussion in that. 100 or maybe 150. And of course, this figure is to be confirmed of patients will be required. So that's -- again, that's not a good number. And that's why with our current capabilities, definitely, the goal will be to move forward deep these opportunities because we could have everything in hand to do that by sales. And that would also be it, by the way, for the commercialization. So that's really one of the key interests moving there. Maybe, Anne, you want to give some numbers on all this.

Yes, with pleasure. So let me please share with you some maybe more precise view on our cash runway. So as you know, as of June, the cash and cash equivalent was EUR 56.9 million. And in addition, we received in July a milestone payment for EUR 13.2 million. So we have quite a comfortable cash position today and this cash position fully covers our plan on NASH and in total, it covers the full completion of the ongoing Phase II DESTINY trial for PXL065 in NASH until the readouts, which are expected in Q3 2022. So coming to the earlier program, so our funding capacity depends on a number of factors starting with the level of royalties and sales-based payments that we received from Imeglimin in Japan. So since we are extremely confident about our plan, we believe that we should not wait. And we aim to strengthen our balance sheet and are currently considering additional funding by equity on non-directive, which will be used to further accelerate our development plan in an IND. And maybe last comment, as Thomas mentioned, the 2 AMN proof-of-concept studies are only few million. We believe that it will be less than EUR 10 million to fully implement this study. So we are very committed to funding these trials.

Okay. So would you say you would reiterate your prior guidance, which was kind of cash through 2022?

Absolutely. Yes.

We have a question about the Imeglimin product that we make. Now that it has been commercially launched, have you collected feedbacks from Japanese professionals? And what are the nature of this feedback, Thomas?

Yes. Yes, absolutely. Well, I mean, Sumitomo has done this, that, of course, part of the work to really indicating the market. And so of course, they wanted to know what could be really the main attribute of the products there. So the key attributes that really have been emphasized by the market and by the prescribers really to Sumitomo on Imeglimin are the following. First, really the novelty and the mechanism of actions, they are. It's a dual mechanism of action targeting the 2 key effects of diabetes. So improving the beta cell function as well as improving into resistance, which is unique. And of course, the prescribers are very -- really bullish on that because in contrast to other products to enter the market, I mean, we'll be able to really target the root of the disease. And so, they believe that it's going to be very important. They also emphasize given that mechanism or the potential to slow down really the progression of the disease and to also prevent the occurrence of the diabetes complications because by targeting the mitochondrial, you can basically protect the beta cell function as well as preventing the micro and macro-vascular competitions there. Third, I think the safety of the product has been reemphasized. Just to remind everyone, in Japan, it's a fairly age population with more than 60% of the population, that its population older than 65, sorry, years old. And so having a safe product really is important really for this population because they are basically more sensitive than their other patients there. And of course, the efficacy that has been shown in the Phase III has been really interesting. As a monotherapy as well as in combination with all existing agents really there. As a reminder, we showed very robust efficacy on top of all other product currently standard of care available in Japan. So I think all this really is that -- is really the foundation for great success in Japan. And so, we are confident that this could basically translate into a significant impact on the market.

[Operator Instructions] So we have a new question on regarding Poxel's increasing focus on the rare metabolic indication in NASH. So maybe, Thomas, you can explain and develop why Poxel has increased its focus.

Yes. Okay. I can get back to this. So what I mean with the approval for the commercialization of TWYMEEG, Poxel, we've been entitled to receive significant cash inclusion from the sales of the product with the milestone with the sales-based payment as well as with the royalties we should get from Sumitomo. And definitely, as a biotech company, we want to reinvest really [ this NASH ] into new development opportunities to deliver new product to the patients and to grow further the company and to deliver, of course, shareholders value to our shareholders. And we believe that really having a balanced approach with disease like NASH as well as rare disease, it could be very interesting because, one, our platform enable us to that. And I think that's really the basis of targeting a kind of activation, targeting within the idea non-genomic pathways of the buyers in June. That could be interesting in all these indications. And so that's why we believe that it's important to fully leverage that. So that's the first point. The second point is that in terms of time horizon, that could be so very interesting. Of course, NASH will take more time. So that's why having this rare disease really could provide short-term -- near-term catalyst there. And we can -- basically, with our plan move forward into the pivotal program for both NASH and rare disease in 2023. So that's really near-term catalyst that could be very interesting there. And so, that's why we lead these 2 approaches. We continue to be extremely really motivated to go there because that could offer significant opportunities. As I mentioned, for rare disease, we will have the ability and the capabilities to move by ourselves into the development and even maybe into commercialization. They are because we'll have everything in hand basically to do that. In NASH, at some point of time, it's going to be for Phase III or later, having a partner on board that could be we believe important there. But if PXL065 when you consume the potential it has linked to pioglitazone as they did reminded us, when I think you that could open up a lot of doors there. And of course, the partner will be needed there, but that could really balance and what we're doing in the rare disease field there. So that's why we feel that really running on our 2 different legs, such as rare disease and NASH is really a good strategy for us going forward with, of course, the very solid foundation that we have with TWYMEEG in Japan. David, do you want to add something here?