IR Lab Therapeutics have closed the books for the Q2 in 2022. And with me to present this And answer some questions, I have the executives of the company. So I will leave the word to them. And let's go. Welcome.
Thank you.
Thank you very much. I'm Niklas Waters, Executive Vice President, Head of R and D. I used to keep the position as CEO of the company. Now I would like to introduce Richard, who's come into the company to support the development the further development of our activities. And he comes into the company with a plethora of experience from business and finance in our industry.
Welcome, Richard.
Thank you, Nicholas. Thank you very much for the warm welcome, and welcome to our quarter 2 presentation. And of course, this morning, we're also joined by Victor, our DFO. So maybe to start, we'll just flick through some slides to draw your attention to our disclaimer and forward looking statement. As you know, we're a publicly traded company.
I am really very welcome to the warm welcome I've received In joining UrLab and taken quite a few months now during the recruitment process in the summer to take a deep dive into the science, Speak to some of the patient facing members of our staff, and I can tell you that I'm really quite reassured that we have a very strong pipeline. We have every potential of offering real benefit to patients with Parkinson's disease and really growing a very valuable pharmaceutical business. So I'm very excited to be here. And at this time, of course, as many of you know, we are totally poised for success. After 8 plus years Of intensive research, we now have 4 drug candidates that are really positioned for very high value inflection points.
Our discovery platform, I think, is truly validated as disruptive technology with the capacity of really producing innovative and unique molecules, And you can see here just a brief summary. As we know, mestopitan is poised for Phase IIb data at the end of the year, paripamab at the end of next 2 preclinical assets to enter the clinic the year after and a very exciting discovery program that's ongoing. We truly have an awful lot on our plate, and I'm very pleased to be here and support Nicholas and the team in developing our business. So we are developing drugs for Parkinson's disease, patients that are living with Parkinson's, And our pipeline has tremendous potential of really and truly being blockbusters. ISP platform, I think, is truly validated now as helping us to rapidly and efficiently develop very effective brand new molecules that have a perfect biological fit to address the symptoms of CNS disease.
Our pipeline is patient focused, which I think is really important to treat the symptoms of Parkinson's disease during that disease journey. One candidate is already out licensed to Ipsen, another Phase IIb candidate is poised for success at the end of next year and the 2 preclinical assets that will enter the clinic next year. This clinical and commercial proof of concept by Ipsen, I think, is truly of great value and adds an awful lot of traction to the value creation in our business, We'll talk a little bit more about that a little bit later. The organization that have joined is really very, very experienced. Seasoned entrepreneurs with more than 30 years of research experience, specifically in Parkinson's disease rooted in the amazing discoveries and innovation Professor Avi Carlson, who received a Nobel Prize in the year 2000.
We're still a small company, 40 people including consultants, But that's sufficient critical mass to actually make things happen, and we really do make things happen in UrLab. And as you know, we're listed On the Stockholm Nasdaq, and we have a strong cash position as we closed the books, DKK 323,000,000 as of the end of quarter 2. 2 very high value inflection points on the horizon, mesdopetan at the end of this year and parepamat at the end of next year. I'm going to talk through our news flow a little bit later in the presentation. As I was doing my research and learning more about Parkinson's disease or maybe Refreshing my knowledge on Parkinson's disease, as some of you know, I'm a pharmacist and I've been working in the industry for a long, long time.
I was Surprised but also sort of interested to realize it continues to be a very common and equally as severely debilitating for patients as it's always been. Over 9,000,000 patients worldwide, forecast to even double in the next 15 years, and it continues to be a chronic disease with no cure. It's caused by a loss of brain cells, neurodegeneration that otherwise would be producing dopamine, and dopamine is used to control motor functions in our bodies. The standard of care treatment really hasn't progressed in decades since when I was a student, and it's a drug called levodopa But you have to take 6, 8, even 10 times a day, so it really is not very convenient. As we know, it leads to a whole host of complications.
The first complication that we're addressing is levodopa induced dyskinesias affecting more than 30% of patients, And another very severe debilitation of patients with Parkinson's disease is the fact that they lose balance and they fall. This is where our 2nd drug candidate In Phase 2, we'll address that problem. So levodopa induced Dyskinesia. It's a complicated title, I understand that, and it took me a while to get my head around it, so I thought I'd spend a few minutes trying to explain it as I understand it. When Parkinson's patients wake in the morning, they're greeted with muscle stiffness and rigidity.
They just can't move. They want to move, the brain's telling them to move, but they can't because of this neurodegeneration. This is so called an off period, and it's relieved to a certain extent by taking levodopa during the day, and they move into an on period. This is the red area and that can vary from 4, 6, 8, maybe 10 hours a day. But over time, with the neurodegeneration, This onperior becomes bad on.
In other words, they're suffering with this perpetual tremor because they have too much dopamine activity in their body. That is what Mr. Opotam is designed to limit and reduce and extend the good on time. So we can see here that the Red period increases at the expense of reducing the bad on time, and this affects more than 1,000,000 patients worldwide. The second condition that we're addressing in Phase II is that of balance and falls.
Clearly, when patients have severe Parkinson's disease, Not only are they limited in their quality of life, limited by the loss of balance and the risk of falling, but also great stress for their caregivers. It's estimated that 45% of Parkinson's patients actually suffer with recurrent falls. And when elderly patients fall and they're admitted to hospital, This is a huge financial burden on the health care providers, dollars 30,000 or more. So not only would improving balance, reducing falls We have great value to to the patients improving their quality of life, but also huge economic value for for for our society. And again, Probably more than 2,000,000 people worldwide would benefit from this as the disease stands today.
But that's not the end of the journey for UrLab. We've got a really, really well designed and strategically positioned pipeline. As the disease progresses from first diagnosis at year 0 on this map, We can see that the initial signs are bradykinias. They can't move. They wake up and they have muscle stiffness.
They just can't function and they're rigid. We hope that will be that currently is addressed with levodopa with all the complications, and we hope that our 3 program will provide a better solution for that. But the dyskinesias and the rapid movement is being addressed by misdopitan. The falls and balance is being addressed by paripemat. And then these 2 preclinical programs addressing cognitive impairment, apathy and neurodegeneration is really what we're working on with those preclinical programs.
So a very rich pipeline of assets that are going to treat the patients during their disease journey. So that's really the reasons why I joined the company. Very exciting pipeline, totally validated research engine and also the fact that Ipsen have now also offered commercial qualification to our innovation. If we now turn our attention to quarter 2, when I give a brief update on the news in the quarter, then hand over to Nicholas to give an R and D update, then to Victor for some finances, and talk about our outlook and our pipeline and news flow. During the Q2, As you know, we've strengthened the management team from this very, very, very strong position and this very rich pipeline.
We acquired some very valuable know how to support a strong IPR, patent protection, for the 3 program, and those patents are being filed right now. We've continued to speak to investors at multiple conferences during the last quarter. And also Victor was invited to be a guest speaker At an expert session at the Biostock Life Science Summit early in the quarter, talking really about the Ipsen deal, which was really quite a significant deal, Very, very strong validation. And then just recently, we've announced that our LID study with mazopitan has been expanded, particularly in the United States, to include the maximum number of patients of 154. And as I say, I underscore the fact that top line data is still anticipated around the year end.
From a finance point of view, we recorded some sales, mostly to do with mizdopetan and services to Ipsen. Our operating expenses have increased in line with our increased R and D as indeed has our cash flow, but our cash position remains strong, 323,000,000 at the end of quarter 2. Our organization has expanded over the last half year or more but stabilized at about 28 employees plus highly skilled consultants that work with us. And as you're probably aware, the number of shares remains the same. So I think we're in a very, very good position with exciting news flow, strong validated pipeline and a very powerful organization to deliver on our R and D promises.
And with that, I'd like to hand back to Nicholas, who can talk you through this R and D update. Thank you, Nicholas.
Thank you, Richard. Comprehensive and to the point presentation of our state of the status The company right now. I will give you a brief update on the Mestoepatam and Pirapormat programs, including also some words on the preclinical assets that we are Working with right now. So to start with Mesto Pertar, this is a drug which is designed to treat Involuntary movements in Parkinson's disease, so called liver dopa induced dyskinesias. And to give you little bit of a back story.
In the brain, dopamine D1 and D2 receptors are necessary for the control of motor function, And dopamine stimulates these 2 receptors. During after diagnosis of Parkinson disease, patients receive liver dopamine. It's truly a fantastic treatment. It's also almost magically how well it works in the early days after diagnosis for most patients. However, with time, there are complications developed as a consequence of both the disease, but also the treatment.
And in that process, another receptor of the dopamine family appears in the brain in the wrong areas, which leads to and stimulation of dopamine on D3 receptors leads to dyskinesias. So we have developed a mestopetam, which is a dopamine D3 receptor antagonist to protect the brain from entering into this State of dyskinesia. We published the data a couple of years back, the preclinical data a couple of years back now. It was highlighted on the front page of JPET that year. At present, There are a number of treatments out there or strategies to control dyskinesias.
Among those are Various formulations of levodopa to suppress the variation in plasma concentration or to prolong the effect of levodopa, reduce the number of administrations on a daily basis, a clinically meaningful increase in what Richard that 1 hour improvement in Goodon is perfectly enough for a new treatment. If one looks at the standard of care or the most used antidyskinetic compound To treat dyskinesia today, that's amantadine, which was discovered in the late 50s, early 60s as an anti Parkinsonian treatment actually, Somewhat before levodopa, but it also has antidoskinetic properties. And it prolongs Good ON by about 1.5 hours through reduction of bad ON, that is the dyskinetic state. If one looks at the Phase IIa data that we have generated, Phase Ib, Phase IIa data that we've generated in clinical trials with mestopotom, We can conclude that we have the potential with Maestro Putnam to reach around 3 hours of improvement, which is substantially better than previously achieved with other types of strategies. So This is a truly exciting strategy to treat dyskinesia in this patient population.
Currently, we're running international, actually across the globe study comprising of 46 sites in Europe, Israel and the U. S. We have recently announced that we are Banding the study to from the originally thought 140 to 154 patients. This will not impact the timelines of the study As we see it, we have 4 treatment arms, 3 different doses, 2.5, 5 and 7.5 milligrams, WAR5 and 7.5 were really successful in the Phase IIa study and the placebo group, of course. This is a 3 month trial where we are administering the drug for 3 months.
So that's extending from 1 month in the Phase IIa. We have powered the study to detect around 3 hours increase of good ON through reduction of bad ON. We still or we expect top line data around year end this year. And we have promised To announce when we have randomized the last patient in the study, it's patient number 154 or so. This program is run together with our partner, Ipsen.
We are responsible for completing the Phase 2b study, and Ipsen will take on all the activities relating to further development through Phase 3 and marketing of this product. So all that is financed at this stage. This was one of the largest deals that has been done in Sweden in the past 20 years. I think internally, we came to a conclusion it's 5th, And analysts have ended up in the same ballpark basically. So it's a significant deal for us and for our industry.
Going further into Piripemat, this is a drug where we are looking at a totally new treatment strategy For Parkinson disease, balance and falls is the biggest problem of all in Parkinson disease. And we are currently running a randomized placebo controlled Phase 2b trial across sites in Europe. The complications relating to falls and balance are dependent on loss of neural In the frontal cortical areas of the brain and thought to be dependent on the loss of norepinephrine and dopamine transmission. And levodopa, the mainstay treatment for PD, does not have any effect on the symptoms and does not restore function in the frontal cortical areas. And Pirpmat is designed to activate The neuronal pathways in the cortex, which are responsible for balance, but also for cognitive function and other aspects of psychiatric symptoms.
We've run Phase 1 studies. Phase 2a study we concluded a couple of years back and published in movement disorder, and now we're running a Phase 2b study internationally. Next step would be the pivotal trials after we have the data from the ongoing trial. So it's a quite simple development path forward in this indication. I should stress that this is the first or the most the foremost compound addressing these issues in Parkinson's disease.
So a few words on the data would be necessary, we think. If one looks at the Symptomatology in Parkinson disease. There are a couple of classical symptoms, the tremor, the rigidity, the bradykinesia, but also the postural dysfunction. And what we discovered in the Phase 2a study and what the drug was designed to actually do is to add efficacy on top of what is already reached by levodopa. So levodopa can treat the tremor, can treat the rigidity and treat the bradykinesia, But this has no effect on the postural dysfunction or axial symptoms.
And that is where we see significant improvements with Piripemat. So we have an improving balance. We have a reduction in the number of falls and the likelihood of falls. We also see as a consequence of the activation of cortical functions, we also see a reduction in apathy in these patients and improvement in cognitive function. And also very important is that we see that the caregivers report that they feel less stressed by the improvement in these neuropsychiatric symptoms also.
So taken together, this has motivated us strongly to move this asset forward into Phase 2b. And this is a quite simple design of this trial where we have placebo group and 2 dose groups of Piripemat. We are including patients with some mild cognitive impairment that is necessary. These are the fallers. And they are it's necessary that they had fallen a couple of times in the past month, before they get into the trial.
And the primary efficacy endpoints is, of course, the number of falls during a 3 month period, but we're also collecting data on cognitive function and neuropsychiatric endpoints as well. We expect data end of 2023 from this trial. Then we have a number of programs running in the laboratories right Now we have nominated 2 candidates, 942 and 757, which are in preclinical development, And we are moving the P003 program towards that point at this time. For 942, we are focusing very much on restoring cognitive function in states of neurodegeneration. For 757, we are looking at treating apathy in Parkinson's disease, but in a broader sense across neurological indication.
There is a huge need. There is no there are no approved treatments for apathy today. And then the PW03 program, where we're looking at in developing a treatment strategy, which allow for once daily administration of Treatment. I'll come back to that. About looking at the opportunity for 942, if we look at the Total number of people living over 65 living with problems with cognitive function or cognitive decline, it's about 12%.
That's a huge amount of people. And it's also and it's those numbers are much higher, of course, in the root degenerative disorders. So And this depends on disruptions in the cortical functions. And 942, we have discovered using the ISP, has unique ability to restore those functions. Currently, we are running a CMC campaign that is making the product According to rules and regulations, we are moving towards talks and safety studies quickly now, we expect to be able to start Phase 1 studies during 2023.
757, A truly interesting molecule in itself. This is a drug which has the ability to or the potential to treat apathy and perhaps also other neuropsychiatric symptoms associated with apathy. This is a very common symptom across neurological indications. Of course, our focus is Parkinson's disease. But we can see expansions into other types of neurological disorders with this product.
Similar to 942, we are in the middle of a CMC campaign developing the synthesis of API for the toxin safety studies and later on, clinical Phase I studies during next year. Last but not least, The P003 program is a program we have been working on for a while. And as Richard mentioned, we have also acquired some Knowledge that we have used now to design novel patents for this class of molecules that we are We have 2 strategies here, 1st generation and 2nd generation molecules. And we are right now in lead optimization for the 1st generation molecules, and we are looking at candidate identification in the 2nd generation. This is a strategy where we're looking at once daily treatment of Parkinson's disease.
And this strategy should also avoid the classical complications that are associated with levodopa treatment over time. So we expect to be able to treat patients without getting them into the excessive response that leads to psychosis And also to avoid the dips in response during a 24 hour cycle, that is the off time or the slowness of movement that occurs between administrations of levodopa. So we get a smooth effective treatment for the 24 hour cycle. All of these Molecules, all of these programs have been discovered using our internal discovery platform, our proprietary platform, the ISP platform. It's an advanced systems biology approach, which we started developing in the early '90s together with Professor Arvind Karlsson.
And it helps us to predict structures, molecules. It helps us to predict the use of those structures. It helps us to create molecules with the best biological fit that we can find. A consequence is that the IPR is usually very, very strong based on this technology. And also, we end up with 1st in class molecules.
Every round, we have tried To get an INN name from the WHO, we have received unique stem names, which indicates true novelty in the molecules. With that, I thank you all for listening. And I would like to hand over to Richard again for a few words.
Thank you, Nicholas. And as I said in my brief introduction, a truly rich pipeline of very exciting assets From late stage Phase 2b, Phase 3 assets through to Discovery Engine. And I think the Discovery Engine is truly validated now as producing Very novel and effective molecules very efficiently. And the upshot of all of that, of course, is an awful lot of work to do, Tremendous excitement and a very powerful news flow. But before we go there, maybe I should just hand over to Victor to talk us through the finances in quarter 2.
So Victor, please take the floor.
Thank you, Richard. Finances. Well, first of all, we all know that there are some geopolitical instances going on in the world and that affects us a little bit. We can see that our costs are increasing. So we have increased our focus on cost control in the whole organization.
And so we have a good cost control at the moment. You can also see in the middle of the graph or the mid graph that our costs are increasing In line with our development plan and we're showing that we invest a lot in our programs, both the clinical ones, which are the dark gray and the preclinical ones which are the middle, mid gray bar. We have a strong cash position about $323,000,000 sorry, SEK 323,000,000 at the end of the quarter. So that leaves us Quite a good position at the moment. You can also see that our the number of employees has increased steadily during last years, And we now have a very good organization that are able to do a lot for our patients.
So in summary, as I said, SEK 323,000,000. We are increasing in the R and D. The most important figure, I guess, is the cash flow from operating activities, which increased a little bit compared to or almost doubles in the second quarter. And if you look at the first half year, it's also increasing. Net sales, euros 23,000,000 in the quarter and euros 32,000,000 in the first half.
In the 2nd quarter, we should say the €13,000,000 comes from the deferred revenue from the upfront payment from Ipsen last summer, which a part of that was spread out during the finalization phases of the Phase 2b study with mesopis harm. So that is 30,000,000 And then we have invoiced another $10,000,000 for services we have performed to Ipsen. So with that, we would also like to point to our analysts. We're Followed by Redeye, ABG and Edison, who writes excellent reports on us and have a very good knowledge about the company. So if you want an outside view of IR Lab, I really encourage everyone to look at their research reports.
And over to you, Richard.
Very good. Thank you, Victor. Good summary of our financial position. I say we remain in a strong position with regards to cash. So before we close, maybe I can just remind you about our pipeline and our next major event As Dopetam Phase 2b study look to report out the headline data at the end of the year, we also have the possibility of taking that into psychosis.
Paripamat, an unencumbered asset that we're championing through Phase 2 at the moment in balance and falls, top line data end of next year, Also with the potential for a readout in dementia. The 2 preclinical or nonclinical assets that Nicholas mentioned In cognitive impairment and apathy are moving towards the clinic next year, and we're very excited about the potential for the 3 program, which we should designate a candidate before the end of the year. So a strong, strong rich pipeline and multiple unencumbered assets that we're continuing to champion going forward. Of course, this leads to a very strong news flow all around the inflection points of the different assets as we take them through development program. And we're now ramping up the amount of communications that we make to the stock markets, to the medical congresses and our publication strategy.
I think you're going to see a lot more of us and hear a lot more about the development of UrLab over the next 18, 24 months. I think you've possibly seen this before. We call it the Swiss diagram. And I'm really very grateful and very proud to be here Building on this solid foundation that's been established in the last few years and not least have all been totally validated by the collaboration with Ipsen. Moving into this building phase now as we move into late stage Phase III, Phase IIb studies, we also can hope that Ipsen will progress misdopetam into Phase III and some milestone payments along the way there.
But the most important thing is we retain full autonomy to strategically develop our unencumbered assets, either ourselves or in partnership going forward and truly release all the potential of those assets for patients and develop the greatest value for our shareholders. And looking a little bit further out, I think we can really start to be quite Optimistic that these candidates are going to turn into real drugs that will get approved and will really make a difference for Parkinson's patients. So I'd like to close with a summary of our investment highlights. So UrLab truly is a company built on pioneering biology With really disruptive technology rooted in the research of R. B.
Carlson and the Nobel Prize, a focused strategy on treating the troublesome symptoms A Parkinson's disease through that disease journey, real validation with the transaction with Ipsen. We have 4 socks on gold. That's a tremendously rich pipeline and an organization that's really positioned for success and a strong balance sheet. So with that, I'd like to close. Thank you, Victor and Nicolas, for the presentations And open for some questions.
Thank you so much for this great presentation. We will now have Question and answer session will be we will also have 2 analysts in the studio. But first off, you started off as the CEO 1st July. What is your impression of the company so far?
Okay. Well, It really, truly is rooted in great science and scientists. That that is the the first thing. The innovation is is tremendous. And as Nicolas mentioned, This goes back 3 decades or more.
This is really powerful science. And then, of course, you start speaking to the patient pacing Individuals who are giving real life feedback, you know, are unqualified that our medicines really do seem to make a difference to patients. If we can make a difference to patients, we're going to grow a very valuable blockbuster business. I guess the It's like a family and it works really well. So it's a really high quality organization that's very, very effective.
So it's still quite small, it's very effective. And I guess last but not least, in my due diligence, I also spoke to some people, and I can give a quote. 1 of the major investors in biotech Base in Europe said to me that they believe that UrLab is the best positioned CNS company in Europe. So that's very exciting indeed.
You mentioned in your CEO note to the report what you will be focusing on. Can you describe that to our viewers?
Yes, great. Thank you for that question. Sure. So it's a real privilege to join a company on this solid foundation and to complement the management team. So my focus will be synergistic With Nicolas and the team, Nicolas will now have sort of unencumbered focus to concentrate on delivering our R and D milestones and promises.
And my role is really to promote the company to the investor community, to the pharmaceutical sector at large and really raise our profile through the media as well. You'll see a lot of me, I think.
Thank you. So let's move on to some questions from analyst firm Redeye. With us, we have Fredrik Thore. Please welcome. Hello, Fredrik.
Thank you. Yes, my first question was about Neste Petain. Obviously, it will be a very important event for investors, yes, the half year going ahead. What's your view of the evidence so far? And yes, what should we expect In terms of the data for the results?
Okay. Well, of course, it's a blinded study, so we don't have sight of the data so far. I've alluded to the fact that Patient facing staff have been very encouraging and complementary to the data and the effects. So I have no idea what the data was so, but I'm very encouraged by that. But we we did put together some slides earlier in the slide deck, which we can possibly toggle back to, and, I I was very pleased when I pulled these slides together with Nicholas and the team, because this is a compelling dataset from our Phase 1b2a studies.
Clearly, we can see that mizdopetan does what it's designed to do. It has these postural dysfunctional effects. And then look at the data here, 35% improvement in balance, 55% reduction in falls. That is going to give patients tremendous confidence. And again, that confidence will probably lead to alleviation of apathy and a significant reduction in caregiver distress.
I'm very, very optimistic about this. Data of this quality And the very, very clear gap between placebo and active is quite rare to see. Of course, larger numbers are what you need to get the statistical power, But I'm very confident about this.
And my second question was about maybe the preclinical assets and The business strategy. I believe, Nicolas mentioned a few reports earlier that maybe you could out license it very early in the preclinical stage or in the Phase I stage. Yes, what's your view on that? And how do you want to grow the company? Sure.
Well,
I mean, out licensing is really helpful. Clearly, we're still a small company. We can't do everything ourselves. But the most important thing is that we take these unencumbered assets as far forward as we can to really deliver and demonstrate the real value that they can bring to patients and also release The untapped value that they have in terms of the fish out and sell returns. So the nice thing is that they're unencumbered.
We have complete strategic We're indebted to nobody for these assets. So I think we need to watch and see, but we certainly are very excited to take these as far forward as we possibly can.
I guess a very short final question was about, yes, with your preclinical assets Targeting cognition and apathy, I mean, there's potential beyond Parkinson's disease. Yes, what's your view on that? Is that something you could think of in the near term? Or
So I think that's a really good question. Of course, we talk about it. And I'm not fully versed in all the sciences whether or not these symptoms are of the same etiology in Parkinson's disease, which is clearly assignable to the reduction in the dopamine producing cells or whether they're attributable to other things. I think there's possibly more science that I'm not aware of is to answer that question. But you're right, there's tremendous scope for these for these assets.
But then the other thing is focus is really important. If we can demonstrate a reduction in psychosis, in dementia, in apathy in Parkinson's patients, well, you can only imagine that that's just the crack in the door and then there's tremendous potential after that. So that could be part of what we're thinking in terms of strategy in terms of where do we go forward. That would be a very, very large indication of great value to millions of patients and truly a blockbuster potential. Perfect.
Thank you. Great questions. Thank you.
Thank you so much, Fredrik. Now we move on to our 2nd analyst here today and present Gonzalo Artyak from ABG Sundal Kolier, welcome up.
Hello, Gunnar Solen. Nice to meet you.
Hello, nice to meet you. Thank you very much for answering my questions. I will start with 1 around Mesopotam. And by the end of the year, you will report the top line data of Phase 2b. And as as Nicolas said, there is not that much done in that space.
So it's a little bit hard to put it to to find comparables or to put it into the context of the disease. And my question is, well, how much can we consider clinically relevant in terms of the data? You said that, for example, a 3 hour Good on time improvement. That would be really good for patients. But would, for example, a 2 hour improvement be also clinically relevant?
And what about 1 hour?
Yes. Well, I think that's a great question. What does good look like, I think is what you're saying. And what are we trying to achieve? And if we go back So that map where you can see the patient's daily routine, we've said here clinically meaningful increase in good on by 1 hour It's not our words, that's come from literature and from consultation with KOLs.
We know that the best that patients can achieve with amantadine, Which is a very clumsy drug to be taken very short lived, has to be mortally repeated by infusions and subcutaneous administration, very unpleasant drug to take, Possibly 1 and a half hours. So you throw out an example of would 2 hours be good? Well, I think 2 hours improvement in Good On From taking a pill twice a day is a pretty good, for 3 times a day, is a pretty good outcome. So yes, I think that will be great. But time will tell, but this is really quite And the landscape is not cluttered, and the attempts by other drugs have not been very effective.
Yes, I think we've got every opportunity of really hitting out of the ballpark here.
Thank you very much. And I have another Another question in your preclinical pipeline. By the end of the year, you will report your The molecule for the PW3 program, could you give us some color on what's the path forward for this program? Are you planning to also move clinical trials in 'twenty three or you will wait a little bit since you will have a quite busy 'twenty three with other molecules?
Yes. So I think that's a very good question as well. Not least of all, we forget that there's an awful lot of work to go from candidate designation through to IND, you know, CMC, tox studies. There's a lot of work to do there that's not necessarily completed in Gothenburg, but needs to be managed there. And of course, then there's lots of consultation with KOLs, With the scientific and clinical advisory boards and regulators, so I think 2023 is not on the cards for clinical phase 1 in 3, But we'd certainly be preparing for it.
So maybe that would be a 2024 milestone.
Very useful. And one last question is on your actual report from today. You have guided that you have enough cash for the following 12 months. What can we like fairly assume that you're including in terms of expenses in this cash burn? Is it the are you including the Phase 2 the Phase 1s that you will start in 'twenty three and or this part will it's not yet included and you're only accounting for what is happening now?
Yes. Well, I think we're well positioned for CAS. And look at our historical CAS burn there. We can't give precise guidance on CAS runway. But you know Phase 1 studies are expensive but they're not outrageous and we do manage them very efficiently.
So I think we have sufficient cash to go into those studies for sure. And of course The Mr. Opatan Treddy and the Preprimat study are fully financed as well. So I think we have a good cash position.
All right. Thank you very much.
Very good. Thank you so much for the questions.
Thank you so much, Gonzales. So we have actually two questions from our live chat Regarding Piripemat. So is there any talks about distribution deals similar to the Ipsen deal?
Well, we retain full strategic flexibility. So we could potentially take it into partnership and allow somebody else to work with us in developing it. We could go further ourselves. We have complete flexibility. We're always speaking to industry.
You can't develop drugs on your own. We need partners, Whether you need them at the discovery phase with the engine or the preclinical or the clinical phase and certainly for the commercialization. So Yes. We'll continue to deliver the best possible strategy for the assets, for the patients and for shareholders.
The next question there was, what is the cost for Phase IIb studies roughly?
How long is the piece of string? We've got it. There's a lot to do here. So it's difficult. I can tell you that in oncology, Cost per patient is running somewhere between $120,000 $150,000 per patient.
It's substantially less in our programs In the ballpark, it's sort of $40,000 or $50,000 per patient. So there's a lot to consider here, not least of all the statistical analysis plan, but It's difficult to give a ticket price for a Phase 2b study and it depends all the other things that we want to study in parallel. So an endpoint is really valuable, but all the supporting data is also extremely useful. So it's a difficult question to give a number.
If I put on the shoes of a shareholder, What can we look forward to during the rest of 2022?
That's a really good question. There's a lot to look forward to for the rest of this year. As Nicolas mentioned, We're quite transparent. We're as transparent as you can possibly be with the news flow on a study. So the mesdopepan study is getting to the end of the recruitment phase.
We've already said that we'll be completely clear when the last patient is randomized, we tell you when that is. We know that this is a 3 month or 12 week treatment cycle, then you can do the math, so you can work out when the last patient comes out of the study. And then you know that we then need to clean the data, lock the database and do the statistical plan. So do the math yourself. You can work out that around the end of the year, we're going to get this data and say everything is lined up and it's ready to go.
But then, you know, we've also got the 3 program where we've made such fantastic progress during this year so far. As I joined the company, there was a little party In Gothenburg celebrating a huge preclinical study that was very informative in that program, so I think we're getting close to nominating a candidate. Nominating a candidate with that robust scientific preclinical pharmacology and toxicology is a really big step. This has never been done before. So being at that point and being able to announce that by the end of the year is also a really significant milestone.
And as we said, next year, of course, there's a lot going on. So yes, very exciting time to join the company. A lot of news flow and a lot of value to be added to our pipeline.
Thank you so much. And I would like to say to the audience that if you have further interest or more questions, turn to the IR Lab IR page for more information. Very good. Thank you so much for participating today.
Thank you very much for hosting us. Thank you for the questions. Thank you.