Hello everyone, and welcome to this live webcast on the occasion of the release of the half-year financial results of the company, Poxel. So today, we are pleased to welcome Thomas Kuhn, Chief Executive Officer, Pascale Fouqueray, Vice President, Clinical Development and Regulatory Affairs, and Fanny Bosa, Vice President, Finance, who will give you an insight on the financial results over the course of the first half of 2023 of the company. During the presentation, you can ask the questions in the question tab below your screen on the right. The management will address them at the end of the presentation. Thank you, everyone. I'm now giving you the floor to you, Mr. Kuhn.
Thank you very much. Good morning, good afternoon, everyone. Thank you for joining us today. I'm Thomas Kuhn, the CEO of Poxel, and I'm today with Pascale Fouqueray, in charge of Clinical Development and Regulatory Affairs at Poxel, and with Fanny Bosa, in charge of Finance at Poxel. After my introductory comments and a brief summary of our first half 2023 corporate and business update, Fanny will review our half year 2023 financial results before leaving the floor to Pascale to go through our rare metabolic disease programs opportunities. I will then conclude, and we'll open the call for questions. Before we begin, this is our forward-looking statement.
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. Let me start with a summary of the first half highlights. As announced in March, we have significantly extended our cash runway for two years through Q2 2025, based upon a successful restructuring of our debts, concurrently with a new equity-linked financing, assuming a full draw. This debt restructuring agreement postpones repayments until Q1 2025, at the latest, to be repaid with positive net royalty flow to Poxel, anticipated to start in Sumitomo Pharma fiscal year 2024, based on the strong growth trajectory of TWYMEEG sales.
Concurrently, we've also implemented an equity-linked financing with IRIS, which fully drawn down would provide us a cash visibility until mid-2025. This has been an important step for the first months of 2023 and for the company's progress. Since then, we've been fully focused on working on additional financing options, which include partnership discussion related to our programs, for which we have very active discussions, with the objective to pursue our strategic plan in rare diseases. As mentioned, the sales of TWYMEEG, our first approved drug for type 2 diabetes patients in Japan, has showed a strong growth trajectory in the past few months, with a 23% growth over the last quarter.
Current Sumitomo Pharma forecast for its 2026 fiscal year would imply a 90% growth sales over the full year of 2022, and give us confidence in the timing of royalty rate increase to the next threshold, being 10%, which we expect to happen before the end of Sumitomo Pharma fiscal year 2024. Regarding our clinical development programs in rare disease and in NASH, during this half year, we have continued preparing the ALD plan with phase II proof of concept studies that are ready to launch, pending additional financing, which we are actively working on. We are very proud to have been chosen as the winner of the 2023 edition of the i-Nov contest, financed by the French state, for our program in ALD.
This is a great recognition of our program and the work of our teams, and the grant will contribute in part in the financing of this phase II proof studies. In parallel, we've also finalized the phase II and phase III plan for PXL770 for the treatment of autosomal dominant polycystic kidney disease, ADPKD, and made progress in the design of the pivotal program for PXL065 in NASH. As a reminder, the plan for PXL065 in NASH is to move forward with a partner, and discussion have been initiated following the results of our successful phase II study DESTINY trial that we released end of last year.
In line with our commitments towards patients, we've pursued our involvement with ALD patient associations, including with the Alex, The Leukodystrophy Charity, which hosted its community weekend in April, and with the United Leukodystrophy Foundation, which organized a scientific symposium and family conference back in June. Organizationally, we continued to execute upon the saving plan we initiated back in 2022, which include a significant workforce reduction to 15 employees as of today. The saving plan aims to adapt the company resources to the current clinical development plan, while preserving critical resource and competencies, specifically to execute our rare disease plan. We've also decided to resize the board to four current members. So let me now go into more detail. As mentioned earlier, we finalized agreement with our lenders and with IRIS in March, and this has been a very important step for the company's progress.
Indeed, thanks to the successful restructuring of our existing debt and the new increased equity link financing facility, our cash runway is now extended through mid-2025. In both agreements with our lenders, IPF and the banks with whom we've contracted a PGE loan, which is a French government guarantee loan, amortization payments under the existing debt facility are now postponed to initiate when the company expects to receive positive net royalty flows from TWYMEEG sales in Japan, which is expected in Q1 of 2025 at the latest under conservative forecast. As a reminder, what we call positive net royalties are all royalties that Poxel receive from TWYMEEG net sales above 8%, as the first 8% are paid to Merck Serono in accordance with the licensing agreement we have with them.
Therefore, net royalties will be positive for Poxel once TWYMEEG royalties on net sales percentage will reach 10% and above, which will occur when net sales exceed JPY 5 billion in the fiscal year. According to the current forecast, we expect to reach this threshold before the end of Sumitomo fiscal year 2024, so end of March 2025, and positive net royalties as well as sales-based payment will then be directed to the debt reimbursement until the loan is fully repaid. We expect the PGE loan to be fully repaid in Q2 2028, and IPF to be fully repaid in Q2 2029 at the latest, again, based on the conservative forecast. After this time, subsequent net royalties and sales-based payment will be brought back to the company. Concurrently, we entered into a new equity link financing arrangement with IRIS.
An initial amount of EUR 3.5 million has been drawn down, and since then, two additional tranches of EUR 600,000 have been drawn in May and July. At our sole discretion, we have the option to draw additional tranches for up to a total of EUR 15 million over two years, with the sole condition that the total outstanding amount held by IRIS will not exceed EUR 7 million at any time. With more financial flexibility, thanks to the restructuring and equity link financing, we've been focused since then on securing additional financing options, including ongoing active partnership discussions related to our program, with the objective to pursue our plan in rare diseases. I'll get back to this in a minute. This debt restructuring has also been facilitated by TWYMEEG's strong growth trajectory, providing increased confidence that TWYMEEG royalties will generate substantial future cash flows.
Moving to the next slide, I will go into more detail on this sales trajectory. So as you can see, we've observed a very strong growth trajectory in sales in the past few months. Full year 2022 sales have exceeded Sumitomo Pharma forecast by more than 20%. And based on this, Sumitomo Pharma full year 2023 forecast would represent a 90% growth over 2022. Based on the current forecast and conservative assumptions, we expect 8% royalty on net sales for the 2023 Sumitomo fiscal year. We then expect 10% royalty on net sales, as well as a sales-based payment of JPY 500 million, so roughly EUR 3.4 million, during the Sumitomo Pharma fiscal year 2024, upon reaching JPY 5 billion threshold net sales, which is roughly EUR 34.4 million.
Beyond 2024, we expect to receive higher escalating double-digit royalties, as well as additional sales-based payments upon achievement of contractually based sales thresholds. Moving to the next slide. TWYMEEG is an important addition to Sumitomo's existing number one diabetes franchise through its differentiated dual mechanism of action, leading to a favorable efficacy and safety profile. Today, it has a key positioning in Japan, thanks to its dual mechanism of action. Indeed, it can be prescribed, and it's mainly prescribed as an add-on therapy to any type 2 diabetes therapy, but it can also be prescribed as a monotherapy. There have been an increasing combination use with DPP-4 inhibitors, but also more recently, with SGLT2 inhibitors.
DPP-4 inhibitors are the most widely prescribed therapeutic class for type 2 diabetes patients in Japan, and SGLT2 inhibitors are more and more prescribed in Japan, given their additional benefits, specifically in kidney protection. TWYMEEG benefits from Sumitomo's strong sales and marketing infrastructure. Additionally, Sumitomo continues to be very actively promoting the product at conferences and through additional publication, which is contributing to the adoption and raising product awareness. As an example, nine abstracts based on imeglimin in phase II-B and phase III clinical trial were presented at the 66th annual meeting of the Japanese Diabetes Society, held in Kagoshima, in Japan, in May 2023. As you may know, a phase IV, 52-week, open-label, long-term study of imeglimin in Japanese type 2 diabetic patients with renal impairment is currently ongoing in Japan.
to strengthen TWYMEEG profile in this key subpopulation, as well as in the elderly subpopulation, and the top-line result for this trial is expected in 2024, roughly mid-2024. For territories not covered by our agreement with Sumitomo, we are having discussion with various potential partners for imeglimin commercialization in several countries. These countries are not in Europe or in the U.S., but includes, for instance, India, where local companies have received approval and have launched imeglimin in monotherapy only. We'll, of course, keep you informed if we've reached the point of establishing agreements. Moving to the next slide. As mentioned earlier, during the first half, we pursued our corporate saving plan initiated in 2022, with the aim to adapt the company resources to the current clinical development plan, while preserving critical resources and competencies. The company workforce has been right-sized.
The organization of the board has also been reviewed and is now composed of four members. Khoso Baluch as our new Chairman of the Board, Pascale Boissel and Rich Kender as our independent board member, and myself. I will now leave the floor to Fanny, who will review the financials for the first semester. Fanny?
Thanks, Thomas, and good morning, everyone. I will now review the financials for the half year 2023. Starting with the revenue on the next slide. Revenue for the first half of 2023 reflects JPY 148 million, or EUR 955,000 of royalty revenue from Sumitomo Pharma, which represents 8% of TWYMEEG net sales in Japan. Based on the current forecast, we expect to receive 8% royalties on TWYMEEG net sales in Japan through the Sumitomo Pharma fiscal year 2023, so from April 2023 to March 2024. And as you know, as part of the Merck Serono licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales of imeglimin, independent of the level of sales. So moving to next slide.
As we have just seen, our revenue in the first half mostly reflects royalty revenue from Sumitomo Pharma. As reported in cost of sales, we pay Merck Serono a fixed 8% royalties based on the net sales of imeglimin, in accordance with the Merck Serono licensing agreement. So as a biotech company, the majority of our resources are allocated to research and development activities. In the first half of 2023, the R&D expenses amounted to EUR 19.3 million, and they include primarily the impairment of PXL065 for an amount of EUR 16.6 million. So this is a purely technical impairment, aiming at being compliant with our accounting rules.
It takes into account the company's need to obtain additional financing to pursue its development NASH, plan in NASH or ALD, its current market capitalization, and the macroeconomic context in which it operates. However, we consider that the potential of PXL065 in its targeted indications, so NASH and also potentially rare diseases, remains unchanged and very promising. So depending on the evolution of ongoing financing initiatives and discussion for a partnership for PXL065, the company will reassess the value of the PXL065 at the end of the year. So the rest of the R&D expenses are decreasing in line with the company's saving plan. R&D expenses are net of the R&D tax credit, so Crédit Impôt Recherche in France.
So that resulted in an income of EUR 300,000 for the first half of 2023, as compared to EUR 900,000 for the corresponding period in 2022. General and administrative expenses totaled EUR 4.3 million for the first half of 2023, so similar to the corresponding period in 2022. The financial loss amounted to EUR 3 million for the first half of 2023, compared to EUR 1.2 million during the first half of 2022, and it primarily reflected the interest attached to the company indebtedness.
So to conclude on this, on this slide, so the net results for the financial period ending at the ending June 30, was a net loss of EUR 26.2 million, as compared, as compared to a net loss of, EUR 13.4 million in the corresponding period in 2020 . So moving on to the next slide now with, our assets. So intangible assets amounted, amounted to, nineteen thousand euros at the end of, of June. So and it, as I said, it primarily, reflects, the impairment loss for the entire value of the PXL065 assets. Our cash and cash, equivalents amounted to EUR 7.6 million at the end of June, as compared to EUR 13.1 million at the end of December 2022 .
The change in cash reflects the cash burn from operations, which is partially offset by the IRIS financing. So we go to the next slide with our liabilities. So total shareholders' equity amounted to minus EUR 25 million at the end of June, as compared to minus EUR 18.2 million at the end of 2022, and the variance mostly reflects the H1 2023 net loss, partially offset by capital increase due to IRIS conversions. The total financial liabilities amounted to EUR 47 million, compared to EUR 44 million at December 2022. And it mostly reflects so EUR 33 million euro for the IPF debt, EUR 6 million euros for the PGE loan, and EUR 6.4 million euros for the IRIS financing related, so it's non-converted amounts at the end of June.
So following the debt restructuring in March and given the postponing of capital repayments, the full PGE and IPF debt have been classified as non-current liabilities at the end of June. So moving now to the statements of cash flow. So the cash burn from operating activities amounted to EUR 7.8 million for the first half of 2023. That compared to EUR 13.3 million for the first half of 2022. The cash flow from financing activities amounted to EUR 2.4 million at the end of June, similar to the previous year, and mostly representing the IRIS equity-linked financing. So based on our cash position on June thirteenth, amounting to EUR 7.6 million, the full rhythm of the tranches available under the equity-linked financing with IRIS.
The current research and development plan, which do not include the initiation of the phase II clinical POC in AMN studies for PXL065 and PXL770 in ALD, and a strict control of the company's operating expenses. We expect that our resources will be sufficient to fund our operation and capital expenditure requirements through Q2 2025. Thank you for your attention, and I will now hand over to Thomas.
Thank you very much, Fanny. So as you can see, this chart summarize our pipeline, showing the three pillars of our strategy: rare metabolic indications, NASH, and type 2 diabetes. To further strengthen the opportunity in NASH with PXL065, in July 2023, the European Patent Office granted Poxel a new patent for PXL065, which describe a specific form of PXL065 with unique properties. This recently issued patent provide additional protection through 2041, with the potential for an additional five years through patent term extension. In 2022, as a reminder, we were granted the same patent for PXL065 from the U.S. Patent Office. I suggest now to go to the rare metabolic disease programs, and Pascale will summarize our developments. Pascale?
Thank you, Thomas. Good morning, everyone. So I will now provide you an update on the two rare metabolic disease that we are working on with our compound, PXL770. So next slide, please. So as you may remember, so adrenoleukodystrophy is a monogenic neurometabolic disease resulting from a mutation in the ABCD1 gene. This gene encodes for a peroxisomal transporter, which is responsible for the transfer of the very long-chain fatty acid in the peroxisome. And as they can't be degraded into the peroxisome, the VLCFAs will accumulate in the cells, including neuronal cells. So because ABCD1 gene is located on the X chromosome, the men are affected by the disease, although heterozygous women may develop also the symptoms later in life and with milder intensity.
So the ALD prevalence is around 25,000 patients in the U.S., and overall worldwide, 500,000 patients. The diagnosis of ALD is often delayed, it's a difficult diagnosis, but it should be facilitated by the development and the spreading of newborn screening program. X-linked ALD is characterized mainly by three core clinical syndromes, depending on whether it affects the brain or the spinal cord within the central nervous system. So the rapidly progressive leukodystrophy or cerebral ALD affects the white matter, leading to cognitive and neurological disorder, and it occurs with the first peak of incidence in children roughly aged eight-10. Then the slowly progressive myeloneuropathy, or adrenomyeloneuropathy, is due to spinal cord neuron degeneration and develops gradually in adulthood, with mainly gait disturbance, spastic paraparesis, and sphincter disturbance.
But at any time, adults with AMN can also develop the serious cerebral form. Last, the primary adrenal insufficiency will occur in almost all subjects during their lifespan. On the next slide. So the PXL770 is a direct AMP kinase activator. It is the first molecule to be evaluated in clinical pathology, and AMP kinase is an intracellular energy sensor, which promotes metabolic and functional adaptation of the cells to their energetic environment. We have shown that AMP kinase activity is depressed in several pathological conditions like NASH, diabetes, ALD, and ADPKD. And so the pharmacological activation of AMP kinase with 770 can restore various pathways, which explains its potential in the above-mentioned disease.
So this slide illustrates the pathophysiology of ALD on the left part, and the beneficial effects that are triggered by AMP kinase activation, including the decrease in the fatty acid pool, the increased expression of a rescue transporter, the ABCD2, from the same family than ABCD1, and some broader effects of improving mitochondrial dysfunction, reducing inflammation and cell suffering, which are all key components of the disease. On the next slide. So we have extensively investigated the effect of 770 in vitro on the left panel, and also in ABCD1 null mice. And we have observed this strong decrease that you can see on the left panel in VLCFA after treatment of patient cells with 770. But we observed also this effect in plasma and also in spinal cord from the genetic mice.
This was associated as well with improvement in the histological structure of motor neuron, here in sciatic nerve, as well as improvement in the locomotor capacities of these mice. And all the results that we have shown here with PXL770 have also been observed with PXL065, and the data collected with the two compounds have been published in 2022 in two different journals. Next slide, please. So here on this slide shows that we previously PXL770 in NASH indication, first in preclinical setting and also in two different clinical trials, phase II trial. And we demonstrated PXL770 effects on steatosis, on inflammation, on insulin sensitivity, on glucose control in animal models. So this beneficial effect were recapitulated in vitro in human cells and also in patients during the clinical trial.
So the good translation of preclinical data into clinic for this metabolic and liver parameter confirms the good predictability in this, animal model for this target. So this give us more confidence on the potential of PXL770 for other indications, such as the ALD or the ADPKD, for which we have put together a strong preclinical package. On the next slide. In ALD, there are a limited number of molecules that are currently in development in ALD, and the two most advanced candidates are the PXL065, in the middle. This is a metabolite of pioglitazone with a strong PPARγ activity. And on the far right, the product from Viking Therapeutics, a thyroid beta receptor agonist.
So the liraglutide pivotal trial in AMN subjects did not meet its primary endpoint on the six-minute walk test, the regulatory endpoint, but there was some favorable trends and on secondary criteria or in subpopulation of subjects. And most importantly, the study tends to show that the liraglutide could delay the occurrence of the cerebral form of the disease, which is currently under more specific clinical investigation. On the Viking compound, it's in phase I-B in AMN subjects. The preclinical data confirm a decrease in VLCFA in genetic models of less magnitude compared to 770, and without reported information on histology or functional benefit. Next slide, please. So we plan to initiate two parallel identical studies, one with 770 and another one with 065, to validate the preclinical data, relying mainly on biomarker. These are short studies of 12 weeks.
So as a reminder, we also have an IND for the two compounds, as well as Fast Track and Orphan Drug Designation in this indication. So the clinical team today is ready to initiate the studies, which are expected to enroll 12-24 subjects with AMN, and treat them for 12 weeks with one or the other molecule. And the study will evaluate pharmacokinetics, safety, and activity on key biomarker, the VLCFA, of course, and also the neurofilament light chain marker of neuronal health, plus, other and biobanking. So, on the next slide, please. We keep working on the design of the pivotal study, considering the natural history of AMN, the lessons learned from the liraglutide development. From the patient's voice on their daily burden, and of course, on the, on the regulatory constraint.
So we are here contemplating the option to look for a conditional accelerated approval using postural body sway test amplitude endpoint. So it's a surrogate endpoint, which is more sensitive to capture the balance issues experienced by the patient. And this first path will be continued with a second path, reach the regulatory endpoint, the six-minute walk test. Of course, we will also address multiple secondary criteria: biological, neurological, imaging, as well, in this study. We are also working now on the duration, the sample size, eligibility criteria, and other key aspects for this study. Next slide, please. So developing new treatments in such a rare disease where there is no treatment could generate a lot of value for the company, as the medical need is huge and the number of candidates is quite low.
So it's also a significant commercial opportunity, considering the high price that has been obtained in other rare disease of roughly the same prevalence. The PXL770 has reached proof of clinical efficacy in this indication. These data are expected to translate into efficacy based on the good translation observed previously in NASH indication. So we are ready to move into clinical proof of concept. We are continuing our work in the next, on the next step, with the support of our KOL and being still in contact with the patient association. Next slide, please. So we change disease, and so we move to ADPKD. So ADPKD, it's the most common genetic kidney disease.
It's affecting roughly 140,000 patients in the U.S., roughly the same prevalence in Europe, and it's leading to end-stage renal failure in more than 50% of affected subjects in their fifties. So the disease is characterized by the uncontrolled development of a cyst formation from the kidney tubules, and so the cyst will fill up with fluid and will keep growing, leading to those enlarged kidneys, as you can see on the slide, with inflammation and fibrosis affecting the residual parenchyma. So there is only one drug that is currently approved, the tolvaptan.
It's inhibiting the vasopressin receptor in the kidney, so it has been shown to attenuate disease progression, but its use is limited due to the serious liver safety and the poor tolerability linked to the intense aquaretic part of the mechanism of action, as it promotes, in fact, nephrogenic diabetes insipidus. So they are on the right path, multiple documented rationale for targeting AMP kinase in ADPKD. Activating AMP kinase is a tenet of both disease-specific effect by acting on cyclic AMP, the mTOR pathway, the CFTR channel, which are being shown to be involved in cyst proliferation and fluid secretion, but also on broader effect, increasing the number and the function of mitochondria, so correcting the mitochondrial dysfunction and also limiting inflammation, injuries, and fibrogenesis. On the next slide.
We evaluate the effect of PXL770, again, both in ex vivo cyst growth model and in genetic animal with conditional PKD1, the main gene affected. PKD1 gene deletion, this is one of the main. Not the only one, but one of the main gene involving the disease. The PXL770 suppress ex vivo 3D cyst growth in a dose-dependent manner, as you can see on the left graph. In mouse, we can see significant reduction in kidney weight, as well as in the cyst surface that are observed here. You can see that on the picture. This was associated with an improvement in histological parameter, as well as in renal function, as you can see in the middle panel. All those data have been recently published in Kidney International.
We are currently working on a development plan in this indication, and we are contemplating the option to initiate a lean proof-of-concept study, evaluating the capacity of 770 to decrease the total kidney volume as a marker of target engagement before moving into a pivotal trial. The objective of this pivotal trial would be to apply for a conditional accelerated approval, using the total kidney volume as a surrogate endpoint, and to confirm this effect on the renal function using slope of the estimated glomerular filtration rate, with the goal, of course, to delay the progression to end-stage renal disease and the initiation of dialysis or transplantation. Next slide, please.
So the development of new treatment in a rare disease like ADPKD is critical because of the medical needs, which is persisting despite the availability of tolvaptan, because the indication of tolvaptan is selective and its use is limited by the risk, hepatic risk and the aquaretic side effect, as I mentioned previously. So the tolvaptan has the potential to slow down the progression of renal impairment, but not to stop it. And so there is still a large room for new treatment to be used in combination with tolvaptan.
In addition, contrary to the tolvaptan, which activity is restricted to the kidney because of the vasopressin receptor expressed only in the kidney, the 770 could potentially be beneficial also on the liver cyst growth and liver hypertrophy, which can be impressive in this disease, leading to clinical symptoms in some patients, mainly women. So considering the practical data and the good tolerability compared to tolvaptan, 770 has the potential to bring some benefit in the severe disease. It could be also a significant commercial opportunity, considering the high price obtained in other rare diseases with roughly the same prevalence. I will now turn the presentation back to Thomas for conclusion.
Thank you very much . To summarize, this half has been marked by our debt restructuring, which was facilitated by TWYMEEG's strong growth trajectory, providing increased confidence that TWYMEEG royalties will generate substantial future cash flows, along with an equity-linked financing facility. These two successful operations significantly extend our cash runway through mid-2025. TWYMEEG sales trend has been very dynamic, and Sumitomo Pharma 2023 forecast would represent a 90% increase over the full year of 2022. TWYMEEG growth sets. In parallel, we continue to build the value of our assets, focused on rare diseases and NASH. In rare diseases, we are prepared to launch, as Pascale told you, the ALD proof-of-concept studies, subject, of course, to additional funding, which is our key priority.
The grants we will be attributed as winner of the 2023 edition of the i-Nov Contest, financed by the French state, will contribute in part in the financing of these studies. In ALD, PXL770 is a phase II ready program, as detailed by Pascale. For PXL065, we now have a U.S. and European patent for PXL065, which provide additional protection through 2041, so really strengthening the potential in NASH, but also for other rare diseases. We have adapted the company's resources to our current technical development plan and need, and actively working to finalize other additional financing, including ongoing partnership discussions, to be able to advance our rare disease strategy, starting with our ALD studies.
As a conclusion, I recall that Poxel's mission and vision remains to discover, develop, and commercialize innovative therapies for patients suffering from serious chronic and rare diseases with underlying metabolic pathophysiology. To fulfill this mission, our objective is to apply our strong R&D capabilities to build and strengthen the value of our assets, focused on rare metabolic disorder and NASH. This is challenging time, but we are working diligently on additional financing to move our program forward. I'd like to take the opportunity to thank our employees, the patients and physicians who have participated and will participate in our clinical trial, and you, of course, for your continuous support as a shareholder. We look forward to updating you on our progress. Thank you again for being with us, and I will now ask the moderator to provide you instructions for participants to ask questions. Thank you.
So thank you everyone for your attention. Before starting this Q&A session, I remind you that you can ask all of your questions in the questions tab below on the right of your screen. So to start with the first question, it's regarding the depreciation of PXL065. What were the reasons of this amortization and depreciation, and was that a requirement from the auditors?
Yeah, so maybe I can start with answering this question. I'm sure Fanny will weigh in there. So again, as mentioned by Fanny, I mean, given, you know, the company's market cap, which was really, you know, between EUR 18 million-EUR 20 million, given, of course, you know, the value that was assigned to the product, so EUR 16.6 million, it was decided indeed, in accordance really with our external auditors, and we discussed that with them, over the past week and months there, to really take really this impairment test. So that basically, you know, it could really reflect, from an accounting standpoint, what is required, really, by the norm.
So, again, this is very much independent to the strategy that is currently really pursued by the company on this product. And I recall here that we really, you know, believe in the value that we assigned initially on the product, based specifically now on very successful, you know, phase II results. And as you know, we are working really in parallel partnering the assets so that we can execute our PXL program, for which we have, you know, greatly progressed, as Pascale mentioned, involving, you know, KOL and also, you know, through regulatory interactions there. So this is really purely technical, as we mentioned, given the context, and it should be very much dissociated to the ongoing activities, building the plan, but also having partnership discussion on this asset.
And that's why this value, you know, could be adjusted again upward at the end of the year. But maybe, Fanny, you want to weigh in on this?
Yeah, absolutely, Thomas, I think you said you said everything. This depreciation is only related to a book value or an accounting value, and absolutely not reflecting any any market value of of the asset. As as Thomas said, this accounting treatment can be reviewed at the end at the end of of the year, depending on the on the evolution. This is not something that cannot be reversed.
Thank you both for your answers. Now, regarding the i-Nov Contest, how much more financing do you need for ALD trials following the grant from the i-Nov Contest and for the ADPKD studies?
So our goal indeed is to really, you know, strengthen the financing of the company and to be in a position to execute our first two studies. Specifically, you know, in ALD, but also in ADPKD. In ALD, so, you know, this is roughly a EUR 3 million investment really per trial there. For ADPKD, you have a higher number of patients there, so it's a higher amount than this, roughly, you know, in the EUR 7 million-EUR 8 million range there. So the i-Nov Contest, and so the financial grant that we'll get, you know, will partly really support the financing of these ALD studies.
But as we said earlier, the goal is really to really finalize really, you know, the options we are working on, you know, financing options, partner options, so non-dilutive options, huh, of course, to really be in a position to progress really our programs, and specifically, you know, launch these studies there.
Thank you, Thomas, for this precision. Now, regarding TWYMEEG, which has demonstrated commercial momentum, we know that the current forecast provided by Sumitomo seems rather conservative. It is now, like, JPY 4.2 billion for the full year of 2023, when we already achieved JPY 1.2 billion in Q1. So can you please comment it?
There is indeed a very good momentum on TWYMEEG, and you know, we have very regular contact with our partners, Sumitomo Pharma. And clearly, you know, they confirm that there is a great demand really of the product in Japan. As you know, and as you know, any company, Sumitomo is, of course, you know, constantly looking really at the market demand there. And so they are really monitoring carefully really this. So currently, the guidance is, of course, JPY 4.2 billion. We will discuss, of course, given you know, the recent trend, whether you know, this needs to be revised.
But again, we will do this, you know, in coordination with our partners, Sumitomo. And of course, we'll inform the market accordingly. What is great is that indeed there is really a very strong performance there, as I mentioned. Not only, you know, in combination with DPP-4 inhibitors, which is, you know, the initial positioning, but also, you know, in combination with any standard of care. Sumitomo has confirmed that the product is gaining market share, you know, in combination with any product there. And so we believe that this could lead to a very significant growth.
Of course, Sumitomo, you know, will take all this into consideration, knowing that, as I mentioned earlier, in addition to this, we are looking forward really to getting, you know, the phase IV results really from a CKD trial. Which could further, you know, position the product in a very key subpopulation in Japan, which is the elderly and the chronic kidney disease population, which could lead to a further momentum of the sales there. So, looking forward to all of this, and of course, you know, following, you know, our regular exchange with Sumitomo, we'll get back to the market, when, you know, adjustments, you know, will be required.
Thank you, Thomas. So in your opinion, is it unrealistic to see the first increase of TWYMEEG royalties rate to be triggered in the last quarter of Sumitomo fiscal year 2023?
So it's a good question, and, well, I mean, as I said, today, you know, the forecast is of JPY 4.2 billion. And I think, you know, Sumitomo have been very consistent so far, really, sharing this. As I said, you know, we have regular review of the commercial performance of the product. Clearly, this would represent, you know, a very nice upside, you know, for Sumitomo and us, if we could get to this, you know, JPY 5 billion threshold there. As I said, the product is seeing a nice performance. This is, you know, revisited, you know, constantly, you know, by the Sumitomo team and discussed, you know, with us.
And so, if there are, you know, more information on this, you know, we'll get back to you in due time. But the message basically is that, yeah, indeed, the product is seeing as a very good momentum. So, which is really good for us and for Sumitomo.
About momentum, Sumitomo has now the good interest in deploying TWIMEEG outside of Japan. When are expected the first sales overseas inside the, in Asian partnership? Again, you give more update about the Chinese plan.
So Sumitomo has been extremely focused, of course, in the commercialization in Japan. And as a reminder, and this is really Japan, you know, is a key country in the territories, you know, covered by our agreement really with Sumitomo. And, of course, you know, with their, you know, number one infrastructure, you know, in diabetes. The goal was really, you know, to really leverage all this to support the commercialization. So a big focus has been done in Japan. Of course, you know, there are also, you know, some great potential, you know, in other countries. And one of it is, of course, China, where in which really we have a high number of diabetic patients there.
So all this is, you know, currently really under discussion. As we mentioned earlier, depending on the countries, there will be, you know, the need for more or less, you know, bridging activities to be able to register there. Specifically, you know, in China, where we know that, you know, clinical program is required to confirm, you know, the efficacy and safety potential in the Chinese population. So, as soon as we have, you know, more clarity on the plan in different countries and specifically in China, we'll of course, you know, get back to the market.
Thank you, Thomas. Now we're coming back to ALD. Is the EUR 3 million phase II study cost estimate for both PXL065 and PXL770? Is that combined, or is it for each study separately?
This is for each study separately. Sorry, yeah.
Okay, thank you for this precision. So last but not least, regarding the financing, how much amount of interest on a yearly basis is currently recorded at Poxel for the IPF borrowings?
Fanny, maybe do you want to take this one?
Yeah, sure. Well, at the end of June, the interest expenses linked to IPF is roughly around EUR 1.2 million of cash interest.
Well, this was the last questions, so we are now ending this Q&A session. Thank you everyone for your attention. I am giving the last word now to you, Mr. Kuhn.
Yeah, thank you very much. And again, thank you everyone, really, for your attendance. We hope, you know, this has basically, you know, showed you, you know, the progress that we've made. As I said, I think, you know, this, debt restructuring, combined with this new, equity, you know, financing, was a key first step for the company, specifically really to extend our cash runway, giving us really, two years of visibility.
Now that this is done, as I mentioned, the key priority, and I think, you know, the full team is really, really extremely focused on this, is to really close, you know, one or more really transaction, financing, as well as, you know, partnership, non-dilutive, of course, financing there, given, you know, the market environment. So that's basically, you know, we'll have the financial to execute on our strategy and progress, you know, our plan, and specifically, you know, in the rare diseases with, specifically, you know, the plan phase II for ALD, but also for ADPKD, yeah. So, we are all, you know, fully committed to that.
I hope, you know, to get back to you, you know, shortly, and giving you really really key update on this, on this progress there. With that in mind, again, I'd like to thank you for your support. We'll continue really updating you on our progress, not only on the financing and partnership standpoint, but also, you know, as it relates to our R&D activities. Thank you very much, and I wish you, you know, a nice rest of the day, a nice morning, and a nice afternoon. Thank you very much, everyone. Bye-bye.
Thank you all.