Ram Selvaraju: And then the last question is sort of a combination of a strategic and financial query. Let’s say hypothetically that the EMA agrees that blarcamesine is approvable for treatment of Alzheimer’s disease in the European Union. At that juncture, strategically, what do you expect your preferred strategy to be in terms of whether or not you elect to undertake independent self-commercialization activities in Europe or whether you at that point would look to identify a partner? And does your cash burn guidance of runway for the next four years take into account any pre-launch activity related expenses related to blarcamesine for treatment of Alzheimer’s disease in Europe or are you assuming that if you get an MAA approval that you will look to identify a partner with which to launch the drug in Europe? Thank you.
Dr. Christopher Missling: Thank you for the question. So what we try to decide when it comes to that point is what creates most value for shareholders. So if the most value is created by finding a partner and who has the expertise and the bandwidth and the strength of executing and maximizing sales of the drug blarcamesine for Alzheimer’s with giving us the appropriate incentive to do so with the upfront payment, with milestone payments and royalties, that would be probably the choice. If, however, it is not the case, then there are certain combinations of such features where we could also consider a split ability to market the drug, which could also actually be beneficial for the company and shareholders because we might retain more upside down the road.
So this is really a decision made at the point in time when we are there to maximize shareholder value. On the other point, you asked about the cash utilization rate. Right now, we are not including any marketing expenses and it’s also not necessary because if it comes to approval, you would have the ability to raise funds, non-dilutive fund with debt funding and financing and these sort of, which would not dilute current shareholders. So you would not need to have that money in equity available if you would come to the point that you need to pay expenses for marketing entry for that reason. So we would be in a position to leverage the balance sheet without diluting existing shareholders.
Ram Selvaraju: Thank you for all the clarity and congrats again on all the progress.
Dr. Christopher Missling: Thank you.
Operator: Thank you, Ram. Next question comes from Tom Bishop at BI Research. Tom, you should be live. I think you’re muted, Tom.
Tom Bishop: Okay. Perfect. Can you hear me?
Operator: Yeah. You’re good. Thank you.
Tom Bishop: Okay. I wasn’t clear about this comment about the first cohort of schizophrenia being fully enrolled. And is this a 30-day trial? So would data presumably be forthcoming in H2 at least?
Dr. Christopher Missling: So we have to finish the trial. So it consists of several cohorts and several parts. So this was the first cohort in the first part. And again, I want to point out this is a testament of the execution of the team, which has done this so quickly. And again, we are ahead of time because we are anticipating starting the trial actually in this quarter and we ended up starting the trial in the previous quarter and now already have enrolled the first cohort. So it’s very encouraging. I would leave the analysis and when the study is finished, when we get closer to that point to announce that, but we are very encouraged so far about the speed and the process of the study.
Tom Bishop: What are these different cohorts, what are they targeting and how long does the trial last in terms of dosing?
Dr. Christopher Missling: So there are two cohorts in two parts. The first part is just identifying the doses of what is the best dose for the schizophrenia patients. So it’s an ascending dose escalation part. And the second part is then at the optimal dose, if you like, a longer study of almost 30 days. So that is the second part. So we are right now in the first part.
Tom Bishop: Okay. And it’s good to hear about the phase three Rett trial. What can you tell us about the timing and the number of patients? And I guess it’s to be 50-50 this time with placebo. Can you tell us more about the trial?
Dr. Christopher Missling: Right. So we really think that with Rett syndrome, we have really a good chance of what we refer to learn our lessons from the previous trial, where we really were only impacted by a very high placebo effect and that was contributed among others, as you pointed out, to the 2-to-1 randomization, which gave the sense of a participating family to think that, so 2-to-1 means that two chances are higher to be on active arm and randomizing only a small portion, one-third, to placebo. So 60 patients ended up in the active arm and 30 in placebo. But because of that, people thought or had the impression or certainly the aspiration to have a higher chance of being in the active arm. And that leads for those who are on placebo and are completely blinded, so don’t know if they get the placebo or the active arm, to suspect or hope that they are in the active arm psychologically.
So that’s what is this bias most likely. So to avoid this, we would have a 50-50 randomization, 1-to-1, so that there is no anticipated ability to expect that to be in the active arm and triggering a placebo effect in the placebo arm. So that would be one thing. The other part is there are also features to reduce placebo response by features of the trial, which are specific to technicalities. And then we also would do a larger study, it turned out that indeed the measurements are volatile and only a few participants in the placebo arm could basically noise — cause noise of the signal to be not significant and that’s what we observed. So there was a very good trend in directional improvement, but we have to now make sure that the signal is strong enough to be significant and that’s the ability to do that.
