Diamyd Medical AB (publ)

Hi, and welcome to this live broadcast from BioStock Studio. In Tänselvik, Diarmuid Medical have announced a financing agreement with US specialist investors and this morning published their Q2 report. We are joined by CEO Ulf Harnedius and CFO Niklas Axelsson, who are here to tell us more. And don't forget that the live chat is open, so just send in your questions and the gentleman will answer them after a brief presentation. And with that, I hand it over to you, Ulf.

Welcome, everyone, and I'll start off here by giving you a brief sort of run through the main achievements milestones during this period and also some of the upcoming milestones. And then Niklas will follow with a bit more of a deep dive into the financials. So let's start off here by Just a second here. So it's been, as always, a very intense, intense period and maybe especially intense now as we are getting close to the first interim readout in the phase three trial. So with the milestones that we have achieved, first of all, full enrollment in the phase three trial that is running in Europe and US. So we now have 321 patients enrolled and it's now fully randomized. And this, I must say, is quite a monumental achievement by the team because we have screened patients worth of actually two phase three trials here. We have screened more than 800 patients and now we have 321. the trial and again as a reminder this is the first ever precision medicine trial ever done in in type 1 diabetes meaning that we go for a specific genetic subgroup of the disease and this is also why it's especially challenging to actually recruit for these kinds of trials and again these our clinical sites have never done a a trial like this so This is truly an achievement by the team to have achieved more than 300 patients in the trials. I am truly proud of what the team has done here and all our clinical sites and obviously patients as well that are participating in this trial. And secondly, also on the phase three trial. So it has been selected for one hour session at the upcoming ADA conference that will be in the beginning of June in New Orleans. And this is one of the biggest diabetes conferences in the world. And to be selected for one hour dedicated symposium is quite an achievement as well. I mean, this is a big competition, high competition to get these spots. So that's also something we are very proud of and looking forward to. And then, as Cecilia already mentioned, we have done an equity financing with US sector specialists, where we now have 25 million US dollars ahead of the interim readout in equity financing. And then there is a big upside after the phase three readout in the form of warrants that can generate quite substantial amounts of additional financing. Niklas will go into this in a bit more detail, but this is obviously also something we are very happy about, and the US is our main and first market that we are focusing on, so this is very important. And then also, as the last achievement during the month, and this is also in the quarterly report, we are advancing our readiness in Umeå, in our manufacturing facility, The Swedish Medical Products Authority has been at the site and done an inspection as part of the ongoing GMP certification process. So we want to facilitate GMP certified to produce material for clinical studies. and this inspection went very well and we have only received minor findings that we are currently working on so there's a process in how you answer these findings send them back and then there's back and forth and then the process will after a certain amount of period will be closed and then you get the decision around the GMP certification but it was a very positive experience and again only minor findings so we look forward to the to the next steps in this matter as well. And then upcoming milestones again, the interim readout is coming up now on Friday. So again, this is when 174 patients have been followed for 15 months. We are doing a blinded interim readout, meaning that we are looking at C-peptide, which is the marker for endogenous insulin production. And that's what we want to change with our treatment. So we want to slow down the disease progression by preserving the endogenous insulin production, and you measure this by C-peptide. And on Friday, we will get the information from the DSMB, which is the committee that usually looks at safety in the trial, and this time they will also report to us if at the interim we see a statistically significant treatment effect or not when we look at C-peptide. And it's a blinded analysis and the reason being that we don't want to compromise the integrity of the ongoing pivotal phase three trial. And with a thumbs up on Friday meaning statistical significance, the next step would be then to schedule a meeting with the FDA to start discussing the BLA strategy and we will also then also follow up the trial to the full readout which will come summer of 2027 with where we got all the data that can support a full traditional BLA in the US and also in Europe. And in April, following the interim readout, there will be a warrant exercise period. So we have this, and Niklas will go into this in a bit more detail. So we'll have these warrants that were part of our previous preferential rights issue about one year ago. These TO5 warrants that can be exercised the second half of April with a strike price of 20 kroner in our share. And then also now as part of this very recent financing with a US sector specialist, there are warrants that can also be exercised 30 days after the interim readout at the same strike price, 20 crowns, that can also generate a significant amount of additional financing to the company. But I want to let Niklas go into more of the details around the financials, current cash, the financing we've just done, and also around the warrants and use of proceeds. So please, Niklas, your turn.

Thank you. And hi, everyone. Right. So in terms of the financial overview of Diomid Medical, we've tried to clarify what the situation looks like by reviewing the existing cash. So as of February 28th, we had about 20 million U.S. or the 191 million. Jone Peter Reistadler, One million that we saw in in today's report and corresponding to cash and short term investments and that's obviously not conditional and in terms of use of proceeds and its ongoing business and manufacturing related etc. Looking ahead, so in terms of the new cash pre-transactional cost, we first have the directed issue of shares to new investors corresponding to 25 million. The timing thereof is imminent and it's not conditional. And in terms of how this money will be used, it's essentially very much focused on remaining Dino 3 trial cost. In addition to that, we have the directed issue of warrants to new investors corresponding to up to 100 million. And timing though will be late April or early May. It is, however, conditional. upon warrants being exercised in full, obviously, and also on EGM or extra general meeting approval early April. In terms of user proceeds, that's going to be very much focused on pre-commercial, so market access, medical affairs, LCM opportunities for lifecycle management opportunities, and also pipeline development. And then last but not least, we have the existing TO5 warrants that Ulf was alluding to that may generate another or add another 35 million of cash. Same timing and being conditional upon being exercised and use of proceeds will be the same as for the other warrants. So all in all, in terms of new cash, including conditional elements, we're looking at another 160 million in total US.