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

Ladies and gentlemen, welcome to the Poxel conference call. I now hand it over to Jonae Barnes. Madam, please go ahead.

Good afternoon, everyone, and welcome to Poxel's Full Year 2019 Financial Results and Corporate Update Investor Conference Call. I'm Jonae Barnes, Senior Vice President, Investor Relations and Public Relations. With me on the call, Thomas Kuhn, CEO; Anne Renevot, CFO. Also joining us today are David Moller, CSO; Noah Beerman, President of U.S. Operations and EVP of Business Development; Sébastien Bolze, Chief Operating Officer, EVP, Nonclinical and Manufacturing Operations; and Pascale Fouqueray, EVP, Translational Medicine and Early Clinical Development. We will all be available for Q&A after our call is complete. Earlier today, we issued a press release which included our full year 2019 financial results and a corporate update. For those of you who don't have a copy, you can access it in the Investor Relations section of our website at www.poxelpharma.com. As part of the presentation, we will also be using slides for this discussion. You can access them on Poxel's website in the Investors/Company Information section under the name of FY 2019 Financial and Corporate Presentation. Before we begin, I would like to read our forward-looking statement. Some of the statements contained in this presentation constitute forward-looking statements, which are statements that are not historical facts. These statements are based on the company's current strategy, plans, objectives, assumptions, estimates and projections. Investors should, therefore, not place undue reliance on those statements. The company makes no representation, warranty or prediction that the results anticipated by such forward-looking statements will be achieved, and such forward-looking statements represent, in each case, only one of many possible scenarios that should not be viewed as the most likely or standard scenario. Forward-looking statements speak as only of the date that they are made, and the company does not undertake to update any forward-looking statements in light of new information or future events. In the context of COVID-19 outbreak, which has been declared a pandemic by the World Health Organization on March 12, 2020, the company has undertaken a full review of the potential impact of the outbreak on its business. Considering the rapidly evolving situation, the company is updating this assessment on a regular basis. As of the date of this conference call and based on publicly available information, the company has not currently identified the occurrence of a material negative effect on its business due to the COVID-19 pandemic. However, the company anticipates that the COVID-19 pandemic could have such a negative -- could have a material negative impact in the near future. The worldwide impact of COVID-19 may notably affect the company's internal organization and efficiency, particularly in the countries where it operates and where confinement measures have been implemented by the authorities. In addition, the deteriorating market conditions may impact the company's ability to raise additional funding and/or enter into partnerships. While the company's time lines for its manufacturing, preclinical and clinical operations remain unchanged on the date hereof, the COVID-19 outbreak is likely to have an impact on the company's operations in the same way as for any company operating within the health care industry, particularly delays in the supply of drug substance or drug products or in preclinical or clinical trials as well as delays linked to the responsiveness of regulatory authorities could occur, which could potentially have an impact on certain or all the company's development programs. For today's call, Thomas will begin with a brief introduction covering an update on how we are proactively managing and monitoring for potential impacts to our business operations due to COVID-19. Anne Renevot, our CFO, will then provide a summary of the 2019 financial results. Thomas will then review our full year 2019 accomplishments and upcoming milestones for 2020. We will then move to the question-and-answer portion of the call. I will now hand the call over to Thomas.

Thank you very much, Jonae. Thank you for joining us today, especially during this challenging time. In opening up this call, I would like to provide an update about how we have been proactively managing and monitoring our business operations during the COVID-19 global pandemic. First of all, I believe we are currently in good shape. One, being a global company, we already have in place internal processes and an IT infrastructure that are fully functional for working remotely. Two, our pipeline is a diversified portfolio of 3 clinical candidates, Imeglimin, PXL770 and PXL065, at different stages of development. And three, our manufacturing of drug products and supplies do not rely upon one single vendor. In reviewing Slide 4, you can see that we are taking measures consistent with guidelines from the relevant government agencies where we have offices to help keep our employees, their families and our communities healthy and safe. We were proactive in suspending travel of our employees, especially international trips, in early March. Due to our global footprint, our IT systems are well equipped for our employees to work remotely, which is something many of us are accustomed to already doing. We feel fortunate that it has not impacted our business to date. For Imeglimin, we successfully completed the Phase III TIMES program in December last year. We are currently working with our partner, Sumitomo Dainippon Pharma, in preparing for the Japanese New Drug Application submission, which is on track and expected in the third quarter 2020, with a target launch anticipated in 2021. For Imeglimin in the U.S. and Europe, Metavant met with the U.S. FDA in the first quarter, and ongoing discussions to continue with the FDA about the Phase III TIMES. As soon as we have additional information, we'll provide an update. For PXL770, both the PK/PD and Phase IIa trials were fully enrolled during the first quarter 2020. The majority of patients have completed the PK/PD trial, and for the Phase IIa study, we are currently working with the contract research organizations and investigators towards the goal of patient completion. For the Phase IIa study, 50% of the patients have currently completed the study, and we are evaluating mitigation plans for the remaining 50%. Our top priority is patient safety, and we are currently assessing protocol modification as recommended by the FDA to facilitate achieving patient completion of the study. This has the potential to impact our current time lines for results. For PXL065, we are currently preparing for the Phase II study, and we're in close contact with the contract research organizations and lead investigator about mitigation plans for issues that could arise due to the COVID-19 and possible delays in initiating these studies. As of right now, we are targeting the end of the second quarter for study initiation but will continue to monitor the COVID-19 impact and believe it is in the best interest of the patient and caregivers to begin enrollment when the environment for recruiting patients is stable and safe. Concerning the manufacturing of drug product and supplies, for Imeglimin, our partners are responsible for manufacturing the drug product, and we are currently not aware of any delays. For our NASH programs, we have outsourced this and have multiple vendors that we can work with, which we believe will help limit potential delays. I would like to assure you that we are trying to be as proactive as possible in managing the global impact of COVID-19. This pandemic is unprecedented in our lifetime, and it will inevitably cause disruption to our personal and professional lives. Nonetheless, we are grateful to have an outstanding team and a strong foundation in place that will allow the company to continue to operate and advance. We'll continue to provide updates on the situation as needed. I will now turn the call over to Anne who will provide an update on our 2019 financial results.

Thank you, Thomas. Thank you for joining us today. I will now review our financials. They are presented from Slides 5 to 10. Starting with Slide 5. Poxel reported revenue of EUR 26.6 million in 2019. As in 2018, this revenue mostly reflects an allocated portion of the EUR 36 million of prepayment received from Sumitomo Dainippon Pharma relating to the strategic corporate partnership that was signed in 2017. It also includes the Imeglimin Phase III TIMES program costs incurred in Japan during 2019 that were reinvoiced to Sumitomo. For the record, both components are recognized according to the completion rate of TIMES program. As mentioned in our press release from February 12, 2020, and in today's press release, we have changed our accounting policy on the method used to allocate the transaction price of the Sumitomo Dainippon Pharma agreement to reflect a preferable method that has emerged in the biotech industry since our adoption of IFRS 15 in 2017. You can find more details about this change in accounting policy in our press release today. This change had the effect of accelerating the recognition of the revenue in 2017 and had the reverse effect for the year 2018 and 2019. Importantly, I would like to note that this change in accounting policy had no impact on our cash flows. Moving along to the income statement on Slide 6. As a biotech company, the majority of our resourcing are allocated to research and development activities. R&D expenses amounted to EUR 40.2 million in 2019 as compared to EUR 54.5 million in 2018. R&D expenses in 2019 mainly reflected the Imeglimin Phase III TIMES clinical costs, which were mostly reinvoiced to Sumitomo Dainippon Pharma. To a lesser extent, they also included the clinical study cost for PXL770 and PXL065, our 2 clinical-stage programs for NASH. The decrease in R&D cost was mostly driven by the TIMES program in Japan, for which expenses of EUR 20 million were incurred in 2019 compared with EUR 46 million in 2018. The TIMES program cost decrease during this period is related to the completion of the program. R&D costs are net of R&D tax credit that amounted to EUR 4.4 million in 2019 as compared to EUR 3.6 million in 2018. General and administrative expenses totaled EUR 11.1 million in 2019 as compared to EUR 7.5 million in 2018. The increase in G&A cost mainly reflects the growth of the company and additional full-time employees in 2019 compared to 2018. The financial income amounted to a loss of EUR 1.1 million in 2019 as compared to a gain of EUR 1.1 million in 2018. The foreign loss in 2019 mostly includes a EUR 0.9 million expense reflecting the IPF warrants fair value, which, of course, had no effect on our cash balance. The net result for the financial period ending December 31, 2019, was a net loss of EUR 25.8 million, as compared to a net income of EUR 1.3 million in 2018. Turning to Slides 7, 8 and 9, taxes and balance sheet and cash flows. As of December 31, 2019, total cash and cash equivalents were EUR 37.2 million as compared to EUR 66.7 million as of December 31, 2018. Net financial liabilities, cash and cash equivalents were EUR 27.4 million as of December 31, 2019, as compared to EUR 52.5 million as of December 31, 2018. Please note that this cash figure does not include the second tranche of EUR 10 million from the bond loan agreement with IPF Partner that was drawn in March 2020. For the third tranche, there is access to another EUR 13.5 million contingent on Imeglimin marketing approval in Japan. Our current cash position funds the PK/PD study and the Phase IIa study for PXL770 as well as the Phase II study for PXL065. All these studies are designed for the treatment of NASH. Please recall that Imeglimin development is fully funded by our corporate partners, who will also be responsible for commercialization. On Slide 10, we have listed relevant shareholder information. I would like to note that our historical shareholders, Bpifrance and Andera Partners, remain coholders, and our shareholder base is stable. DeuteRx is now slightly below a 5% holder, and the shares are now captured in the floating section. I will now hand the call over to Thomas.

Thank you, Anne. Turning to Slide 12 and 13. Last year was marked with the achievement of several key milestones for our 3 clinical-stage programs: Imeglimin, PXL770 and PXL065. For Imeglimin, they included the successful completion of the Phase III TIMES program in Japan, which was led by Poxel and run in conjunction with our partner, Sumitomo Dainippon Pharma. There was also the successful completion of an Imeglimin clinical study conducted by Metavant in type 2 diabetic patients with chronic kidney disease stage 3b and 4. In parallel, we also advanced our wholly owned pipeline of NASH-focused programs: PXL770 and PXL065. Alongside our clinical progress, we have also committed to bringing in top talent to Poxel. We appointed Quentin Durand as Chief Legal Officer, who joined Poxel from Dechert LLP, our external law firm where he worked with us for years advising the company. We also appointed Dr. David Moller as our Chief Scientific Officer. David comes from -- David comes to Poxel with deep expertise in treating metabolic disease and in drug discovery and development at major pharmaceutical companies such as Eli Lilly and Merck, and in the biotech arena, most recently as the Chief Scientific Officer of Sigilon Therapeutics. We are thrilled to have them both on board. Turning to Slide 15. I will now provide an overview of the data generated by the TIMES -- Phase III TIMES program in Japan, evaluating Imeglimin in type 2 diabetes in a variety of treatment settings. As you know, Imeglimin is a first in a new class of potential antidiabetic treatments with a differentiated mechanism of action. The Phase III TIMES programs evaluated Imeglimin in several different settings. The TIMES programs explored in over 1,100 patients the effects of Imeglimin as a monotherapy in TIMES 1 trial, in combination with insulin in the TIMES 3 trial and in the TIMES 2 trial as an add-on therapy to other standard of care agents in Japan. The TIMES programs met primary and key secondary endpoints and important objectives in all 3 pivotal trials, showing consistent and clinically significant reductions in HbA1c. On Slide 16, you can see the Phase III TIMES 1 trial design and results. The trial was a 24-week, randomized, double-blind, placebo-controlled, monotherapy trial to evaluate the efficacy, safety and tolerability of Imeglimin administered orally in Japanese patients with type 2 diabetes. The data demonstrated robust efficacy with a highly statistically significant HbA1c reduction and an observed safety and tolerability profile similar to placebo. Turning to Slide 17 and 18. The Imeglimin Phase III TIMES 3 trial, a 16-week, double-blind, placebo-controlled, randomized trial with a 36-week open-label extension period, was designed to evaluate the efficacy and safety of Imeglimin in combination with insulin in Japanese patients with type 2 diabetes and inadequate glycemic control on insulin types. The TIMES 3 16-week portion of the trial, which was placebo-controlled, met the primary endpoint of a statistically significant reduction in HbA1c with a favorable safety and tolerability profile similar to placebo with no severe hypoglycemia events observed. The TIMES 3 36-week open-label results showed sustained efficacy with a favorable safety and tolerability profile in combination with insulin. Lastly, on Slide 19 and 20, I will review the Imeglimin Phase III TIMES 2 trial, which was a 52-week, open-label, parallel-group trial to evaluate the efficacy, safety and tolerability of Imeglimin administered orally as a monotherapy or add-on therapy to other existing drugs in Japanese patients with type 2 diabetes. The study met its primary and 2 secondary objectives, and Imeglimin demonstrated add-on efficacy benefit with other agents with a favorable safety and tolerability profile. Particularly notable was Imeglimin as an add-on to DPP4 inhibitor, showing robust efficacy benefits with the market-leading class in Japan, which is prescribed to approximately 80% of the treated type 2 diabetes patients. Based on the TIMES program and other clinical and clinical results, we believe Imeglimin's profile could be particularly useful for patients in Japan as an add-on therapy with a DPP4 inhibitor in elderly and renal-impaired patients. The TIMES 2 trial further strengthens Imeglimin differentiated profile, showcasing that its dual mechanism of action of increasing insulin secretion in response to glucose and improving insulin sensitivity was observed to show add-on efficacy benefits, especially with agents that have complementary mechanism of action. This is very important because type 2 diabetes is a progressive disease that often involves the need for additional agents over time. Thus, these results demonstrate Imeglimin potential across numerous stages of the disease. The successful completion of the TIMES 2 trial marked the completion of the Phase III program, and Sumitomo is on track for JNDA submission in the third quarter of 2020, with an anticipated product launch in 2021. Now turning to Slide 22 and 23. In U.S. and Europe, our partner, Metavant, continues to make progress. Diabetes is the most common cause of chronic kidney disease with approximately 2.4 million adult cases in the U.S. Despite the large number diagnosed, this patient population is historically underserved. Many approved therapies require dose reduction who are not recommended in this presence of kidney disease, especially as patients progress into stages 3b and 4, where Imeglimin development in the U.S. is currently focused. We believe there is an unmet need for new treatments providing strong efficacy and safety profiles with no risk of hypoglycemia. In July, Poxel and Metavant announced positive top line results from a clinical trial evaluating the safety, tolerability and PK/PD of Imeglimin in individuals with type 2 diabetes and chronic kidney disease stages 3b and 4. The favorable safety and tolerability profile was observed, and PK/PD data from this study was consistent with previous Poxel data. Metavant recently met with the FDA to discuss the Phase III program in this patient population, and ongoing discussions with the agency continue. We believe Imeglimin provides a compelling opportunity for this underserved population based on the current data and profile. Turning to Slide 24. With the potential for Imeglimin to transition into a commercial product in Japan by 2021 and into late-stage clinical trials in the U.S., we will focus more of our internal resources on our exciting wholly owned NASH programs. Last year, we made significant progress advancing PXL770 and PXL065. And this year, both programs will be in midstage clinical trials. Advancing to Slide 26. PXL770, a direct AMPK activator for the treatment of NASH, is currently in the Phase IIa and PK/PD trial. AMPK is the central regulator of multiple metabolic pathways leading to the control of lipid metabolism, glucose homeostasis and inflammation. Based on this central metabolic role, AMP kinase activation has the potential to treat a wide range of metabolic disease, including NASH. Over the last few years, we have presented multiple preclinical studies that are showing consistent and promising results to treat the underlying root causes of NASH. This February, we presented new results from the preclinical NASH model for PXL770 at the third annual Global NASH Congress. PXL770 was observed to reduce liver inflammatory cells, which may contribute to an improvement of fibrogenesis. The downstream effect of AMP kinase activation lead to PXL770's potential ability to address the hallmarks of NASH, which we define as steatosis, inflammation, ballooning and, lastly, fibrosis. Last year, we initiated 2 clinical trials, and we look forward to the results. The first readout, which is currently expected late second quarter, will include an evaluation of the complete PK profile of PXL770 in up to 16 nonalcoholic fatty liver disease patients, who likely have NASH, as well as an evaluation of efficacy biomarkers, safety and tolerability after 4 weeks of treatment. The second readout will be from a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase IIa trial of PXL770 trial to assess the efficacy and safety of PXL770 in approximately 100 likely NASH patients. The study will measure the ability of 3 doses of 770 to change the percentage of liver fat mass assessed by MRI-PDFF from baseline at 12 weeks. Secondary endpoints will include other metabolic parameters. We currently expect results from this study in late third quarter. But as previously mentioned, due to the COVID-19 impact, we are working on mitigation plans and may need to extend the study time line, which could cause a delay. Turning to Slide 28, PXL065. The deuterium-stabilized R-stereoisomer pioglitazone, is a mitochondrial pyruvate carrier, MPC, inhibitor being developed for the treatment of NASH. MPC is the cellular fuel gatekeeper that can be harnessed to augment fat metabolism and also impact inflammation. As a reminder, pioglitazone, the parent drug of PXL065, has been shown in multiple studies to improve hepatic fibrosis in NASH with as many as 70% of the patients seeing resolution of NASH without worsening of fibrosis. However, pioglitazone use is limited by its side effects, especially weight gain. PXL065, as the deuterium-stabilized R-stereoisomer pioglitazone, is based on preclinical data uniquely capable of retaining the NASH efficacy profile of pioglitazone through MPC while having very weak PPAR gamma activities. Therefore, we believe it has the potential to reduce the weight gain side effects while retaining efficacy in NASH patients. In 2019, we conducted a Phase Ia single ascending dose study of PXL065 in healthy volunteers compared to Actos, the branded name of pioglitazone. The trial demonstrated PXL065 was safe and well tolerated at all doses and showed limited conversion to the S-stereoisomer of pioglitazone. This stability is very important since we believe the undesirable side effects are related to the S-stereoisomer. We subsequently conducted multiple ascending dose, double-blind, randomized, placebo-controlled Phase Ib trial of PXL065 to evaluate the safety, tolerability and PK in healthy subjects versus placebo or Actos. Data were observed to demonstrate a safety profile consistent with the Phase Ia trial along with consistent exposure to the preferred R-stereoisomers. These results combined with other clinical and preclinical data enabled us to identify a dose-ranging for the Phase II study that could provide an improved therapeutic profile over pioglitazone. Advancing to Slide 29, you will see there the Phase II clinical trial design for the 36-week trial which we are currently planning to initiate in the biopsy-proven NASH patients late second quarter of 2020. As previously mentioned, we believe that having a stable and safe environment when recruiting patients will be an important criteria in starting the study, so the current time line might change. The primary objective of this trial is to determine the optimal dose or doses to be tested in the Phase III registration trial. As reported, during the fourth quarter of 2019, we met with the FDA, and based on feedback from this meeting, PXL065 is being developed using the 505(b)(2) regulatory pathway. This regulatory pathway offers the opportunity for a streamlined and efficient development program utilizing a subset of the data produced to date by the approved drug pioglitazone. Turning to Slide 30. In summary, I'm very proud that we achieved so many important milestones across all 3 of clinical-stage programs last year. 2020 is poised to be another impactful year for the company. We are looking forward to a number of significant milestones, and in parallel, we'll continue to proactively manage and monitor for developments that might impact the time line of our corporate objectives due to COVID-19. We are committed to working with our Imeglimin partners to bringing this innovative therapy to the market in Japan and more broadly in Asia; and in the U.S., to advancing Imeglimin into a Phase III program. For our NASH programs, PXL770 and PXL065, we are poised for another exciting year with 2 important clinical data readouts for PXL770 and, of course, initiation of a Phase II study for PXL065. In addition, we are planning for future pipeline growth and evaluating additional research and development opportunities from our internal pipeline as well as external opportunities focused on metabolic disorder, including rare disease. We are also conducting preclinical combination studies with our NASH drug candidates to explore the potential to show additive or synergistic benefit to treat the root causes of NASH with other agents in development. In closing today's call, I would like to reiterate our commitment to our mission of developing safe, innovative therapies for the treatment of metabolic disease. We believe that our scientific approach of targeting the crux of these balances at the core of metabolic disease as the potential for differentiated product profiles to address unmet medical needs. We look forward to advancing our programs further and presenting and publishing our results. We are grateful for your support as we continue to build off our accomplishment in 2019. Operator, you may now open the line for questions.

[Operator Instructions] We have the first question from Lucy Codrington from Jefferies.

Just a couple from me. For the planned Phase II study for 065, I wonder if you could let us know how recently the patient needs to have had a biopsy proving their NASH and just whether, I guess, could -- if patients aren't having biopsies over the next couple of months, could that potentially impact recruitment later down the line? Secondly, I just wonder, it seems, or perhaps I've been mistaken, we have been expecting the Japanese filing for Imeglimin in the first half. I wonder if you could provide any color as to why that appears to have slipped into the third quarter. And then finally, if you could give any guidance or loose guidance on your anticipated cash burn for the year, that would be very helpful.

Thank you, Lucy, for your question. So let me address maybe the first one on 065. So yes, I do confirm that we will perform a single Phase II trial in biopsy-proven NASH patients there. As I mentioned during the talk, well, this study is going to be performed in the U.S., only in the U.S., and this study is planned to initiate the enrollment at the end of the second quarter this year. However, as we all know, the situation due to COVID-19 pandemic is evolving extremely quickly. And we want to make sure for the patient and the caregiver that we initiate the enrollment only when the environment will be stable and safe for the patient and for the caregiver. Given that it's very difficult to predict what's going to happen in the next weeks or months, it's difficult for us to give you more clarity and guidance on the precise time line there. We are really preparing for the trial, and we are on time for that. But again, we really want to initiate the enrollments only when the environment will be safe and stable. The biopsy will be part of the screening criteria because it's going to be part of our secondary endpoint that's going to be important for the trial. And so independently, whether there would be a biopsy or not, what really will be important for us is really the environment. And of course, we will update you and the market when we'll have more clarity about, really, the environment given this context. Secondly, for your second question, I think the timing, we have not set at all for Imeglimin filing. If you recall, we finalized the TIMES programs, the Phase III programs, at the very end of 2019. And as you know, it's a very broad program where we have 29 trial, I guess, something like that, roughly 2,500 patients. We have, as you can imagine, a number of data we need to be compiled, and so that's why, of course, it's taking a bit of time, really, to prepare for the filing. I think our team together with the Sumitomo team are currently working extremely diligently. And so I'm very happy to report that, really, we believe that the filing will occur in Q3. We believe that given the context, I mean, the 2 companies have been used to working remotely. We have set key processes to make sure to really keep our time line there. And so we will, of course, update you and the market. But as I mentioned today, I mean, we've -- even further guidance on this Q3. As a reminder, in the past, the PMDA in Japan is used to make the assessment for any new treatment in diabetes within a year. It's a 1-year review. Currently, we know that the PMDA operates and function normally. Again, we don't know how the pandemic will impact that. And of course, we'll keep you and the market up-to-date if there is any change in the timing there. And then for the cash burn. Before I let Anne really clarify a few things. Just want to mention that, as you have understood, besides Imeglimin, and we discussed that and we know that this is fully funded by our partner, we have really 2 key milestones for us, which are PXL770 Phase II program and with the Phase IIa and PK/PD study, and PXL065 Phase II. And as you know, we've taken measures to make sure that we have the cash available to finance these key activities so that we can reach these 2 key catalysts going forward. And maybe, Anne, you can provide further granularity on this.

Yes, sure. So to answer your question, the burn rate, including tranche 3 milestone, will be approximately EUR 2 million per month in 2020. And as mentioned, our current cash position together with the second and the third tranches of IPF funds the PK/PD study and the Phase IIa study for PXL770 as well as the Phase II study for PXL065.

We have the next question from Arsene Guekam from Kepler Cheuvreux.

Three, if I may. First of all, I would like to have more color on Imeglimin development in the U.S. What is the main issue with this program? Because you -- if I'm wrong -- if I'm right, you released excellent data in July, and 9 months later, we're still expecting the launch of the Phase III. This is the first question. The second question is to have a better view on the impact of COVID-19 on your business. Do you expect any delay in launching clinical trial or in your current clinical trial in terms of enrollment of patient or -- I don't know, or supply of the drug? And the last question is about the relationship between pharmaceutical company or biotech company and regulatory bodies. Do you think that the interaction with these bodies would be more difficult or delayed during the crisis?

Thank you, Arsene, for your question there. So to come back to the first question on Imeglimin in the U.S. Yes, absolutely. We released top line results from the PK/PD trial in diabetic patients with CKD stage 3b and 4 in July. Right after, our partner, Metavant, started to work on meeting with the agency. Of course, they had to wait, really, for the full result of the trial, which tend to take a bit more time. Then as you know, you have to really get the FDA feedback for a meeting. I recall here, and we communicated previously on this, that the meeting was supposed to be held earlier in 2019, on the fourth quarter in 2019. But given the alliance in between -- that was set between Roivant and Sumitomo, they decided to postpone this meeting to the next quarter to give the ability for Sumitomo to really jump in a discussion and really validate the strategy that was taken by Roivant and Metavant. And as you know, preparing for this key meeting is very important. And I think Metavant has done a very good job building a very detailed and thorough briefing book. And so now the discussion is ongoing with the FDA. And it's, of course, a critical phase where it's difficult for us to give you any further guidance. But we'll come back to you as soon as we have more information, really, to relay to the market there. So -- but I think Metavant has been really moving this well. For the second question -- for the second and third question on the impact on COVID-19. As I mentioned during the script and I showed on Slide 4 on this presentation, I think, first, we've been very proactive in assessing really the impact of this unique pandemic in -- on our business there and, of course, setting up and putting in place a mitigation plan to ensure really business continuity. So to answer your question more specifically, I think we have 3 different type of impacts, really, for our clinical trials. First, we are very fortunate that we completed all Imeglimin trial in Japan but also in the U.S. last year -- end of last year, actually, in Japan because, of course, this has no impact on these trials there. For 065, the Phase II, we've not yet initiated. We are preparing for it. We planned, as we communicated earlier, to start enrolling the patients by the end of the second quarter. And so we are really preparing for this, being on time. However, as I mentioned earlier, the goal is really to initiate the enrollment when the environment will be stable and safe. We don't want to initiate the trial enrolling patients under this context. The current one that we have, that we are living today, it will not be safe for the patient, it will not be safe for the caregiver, and it will not be good, really, for us. So it's difficult to give you precise guidance in terms of time line because, as we all know, I mean, the situation evolve extremely quickly. The study is going to be performed solely in the U.S. We are in very regular contact with the CROs, with the lead investigator. And of course, as soon as we have more clarity, depending on this context, we'll update you and we'll update the market on this. Third point on 770, again, the situation is a bit different. We have 2 ongoing trial. The first one, the PK/PD trial, it's a relatively short treatment duration, 1 month, with a relatively low number of patients, 16. All the patients were enrolled this quarter. And most of the patients have now completed the trial. So we believe that they will have no impact on the time line, and we are still targeting the readout by the end of the second quarter this year for the trial. For the Phase IIa, the situation is a bit different. Again, the Phase IIa, we have 100 patients that needs to complete the trial. The enrollment is completed. 50% of the patients have now completed the trial, but we have 50% remaining in the trial. So we need to manage that. And again, we are in constant discussion with investigators and CROs, one, to really make sure, which is our priority, to ensure patient safety, that's #1 priority; and then secondly, of course, to try to really have as many patients really completing the trial as under -- during this context we have. As you may know, the FDA has issued recently last week some guideline to really give us flexibility, to give sponsor flexibility on how to potentially adjust the protocol to really facilitate the completion of ongoing trial. So we are following this guidance, ensuring, of course, patient safety. Again, as I mentioned, that's the #1 priority. And of course, we may anticipate some delay, but it's too early really to give a precise guideline on this. But as you can appreciate, we are really working on the case and putting in place different mitigation plans to make sure that things are doing as best as possible for this specific trial there. So that's really the answer for the clinical trial. On the supply, as we mentioned, the supply for Imeglimin is managed by our partner. And as we've heard from them, this is good, no issue. For our NASH product, we are, of course, managing the supply with different CDMOs, different suppliers, different vendors. And so we believe that we have -- we are in a good position to really ensure a good supply for our studies there. And last, on the regulatory side, currently, there are no real delay announced by the FDA and the EMA and the PMDA. But of course, again, in this context, which is very, very unique, we anticipate that there may be delay for nonpriority activities. And so potentially, that will affect our products. But again, it's too premature to have clarity on this. And as soon as we have more information, we'll let you know.

Okay. And then what's your view about your drugs? How do you think the FDA will prioritize your drug, as a priority drug or not?

Sorry, Arsene, I couldn't hear you well.

I just would like to know, you said previously that the FDA will focus on more on very important drug. And I would like to know how do you position Imeglimin and your NASH development in this context.

Okay. Well, again, it's premature to see that, but we've seen that the FDA has, for instance, delayed a few advisory committee. So that's announced. That was announced for OCA today. So again, we don't know how the situation will evolve. We know that anything related to COVID-19 will, of course, be the top priority for the agencies. So let's see. I think this is not within our hands. We do the best. We do our best to make sure that things progress adequately. But again, it's a unique context, and so it's very difficult to appreciate how things will be developed by the agencies.

We have our next question from Andy Hsieh from William Blair. [Operator Instructions] We have a new question from Andy Hsieh from William Blair.