So we are a company founded on the mission to cure Type 1 diabetdiabeteses, when our founder's youngest daughter was diagnosed with Type 1. So there's a very deep purpose behind this company. And we are now currently the only company in the whole world in phase III with a disease-modifying therapy, with a readout from this phase III, an early readout happening March, April next year. So exciting times. Very briefly about Type 1 diabete, but like Adam already touched upon this, what does the disease actually mean? So it's obviously a significant unmet medical need. We've had insulin for more than 100 years. Before insulin, you died. It was a death sentence. After insulin, you could save lives, but insulin is not a cure. Too much insulin will kill you. Too little insulin will kill you.
Now, like also we heard, there is one disease-modifying therapy approved today in the U.S. and a few other territories that is owned by Sanofi, that can delay the time to onset of clinical diagnosis. There's basically nothing else. You have a lot of obviously different insulins and assistive technologies. There's more, well, more than 500,000 people with Type 1 diabetes every year that gets the diagnosis. This is probably could be maybe double if you also take the adult onset Type 1 diabetes into account. It costs almost $100 billion, every year for the society because of the complications of the disease. It leads to a lifelong dependence on insulin. You need to, when you have too little insulin production left because the immune system destroys the insulin-producing cells, you need to supplement with external insulin.
You need to eat right, move right, monitor constantly day and night for the rest of your life. It's a chronic autoimmune disease without a cure, and there's a very high risk also. Even if you have access to all the latest technologies, insulin pumps, even artificial pancreases, everything for you have a very higher, much higher risk for complications, including cardiovascular disease, about 10 times higher risk as a Type 1 diabetic to get cardiovascular disease. And this leads to, on average in the world, 35 year shorter life, like healthy life, which means a life without complications and around 15 years of shorter lifespan, again, because of all these complications.
So this is something we want to do something about by developing a disease-modifying therapy that basically slows down, in the best case, holds the autoimmune attack on the insulin-producing cells so the patient can retain the insulin production. And the treatment we develop, we call it also Diamyd. It's based on a recombinant protein. It's an endogenous protein that belongs in the body, for example, in the insulin-producing beta cells. What we want to do simply is to reprogram the immune system so that when it sees this protein, the immune system understands it's nothing foreign. You shouldn't attack this protein. And in this way, you create what's called immunological tolerance. It's an antigen-specific therapy. So we only touch that one single component in the body. We don't block anything. It's not immunosuppressive. And this also translates to a very favorable safety profile.
We've treated so far more than 1,000 patients with active substance, around 600 with placebo, and there's no difference in the safety profiles, and it's mostly just irritation around the injection site, so this has given us three injections, one month apart, outpatient treatment. It's a precision medicine. This is one of the biggest learnings we and the whole field has done during the past, let's say, decade. It doesn't work in everyone. You need to have the right genetic profile for it to work, and we were in phase III around 15 years ago. We didn't meet the primary endpoint. Since then, we learned our lesson and the field learned their lesson. With an antigen, you need to treat the people who have the right receptor that binds to this antigen. Then it seems to work, and that's the biggest thing now.
It's around 40%, of all Type 1 s out there have the right profile to benefit from this treatment. We have fast track designation in the U.S. for all stages of the disease. Stage III, that's when you get the clinical diagnosis, symptomatic disease. Stage one and stage II, are precursors when you don't have any symptoms, but you have an autoimmune disease ongoing. If you treat them, you can then prevent or delay the time to diagnosis. We are the only company, as far as we know, that have fast track for all of the stages. We also have orphan drug status in the U.S. Briefly, this is an illustrative figure that sort of summarizes the effects we have based on clinical phase II and phase III data, retrospective and prospective analysis.
On the x-axis, you see the beta cell function, so how much insulin the patient is producing. On the y-axis, you have the now actually y-axis, x-axis, that's the way. Time is time, and then you have the function. In a placebo patient, you usually have quite an exponential decrease in the beta cell function over time. And then eventually it levels up when it starts to get closer to zero here, several years after diagnosis. We then give three injections in the beginning when we include our patients, one month apart. Like I said, outpatient treatment, very targeted injection. We go into a superficial lymph node. And what we do is that we change the slope of the disease here. So we see around 15 months from baseline, we have 50%, more insulin-producing capacity compared to the placebo patients. This is what we see in all our data.
When we take all our data, it's very consistently around 50% preservation. What this also means is that we can see that there's a significant delay in the disease progression, and obviously, the longer you follow the patients, since these curves diverge from each other, the delay between the curves becomes longer and longer. We've even seen in some data we have in these early stages, stage one and stage II, that descriptively the data shows even a seven-year delay to clinical diagnosis of stage III diabetes, which really shows the potential here. We also see, and this is all on top of standard of care, so all these patients are already on insulin treatments, insulin pumps, so they are very well controlled.
But on top of that, when we preserve the insulin production, we can see that you get an improvement in glycemic control, which is a very difficult marker to actually see, since in clinical trials, you get an even better care than out there in real life. And now we have a phase III trial ongoing, pivotal phase III. It's done in partnership with Breakthrough T1D, which is the largest patient organization in the U.S. We also collaborate with Critical Path Institute and INNODIA, C-Path we say organization that is working a lot around biomarkers and the FDA to speed up clinical development. And we also work with INNODIA, which is a clinical trial network here in Europe to enhance our patient recruitment. And it's ongoing in Europe and U.S. and like I said, it's the first ever precision medicine trial ever done in Type 1 diabetes.
Where you select your patients based on genetics, it's also the only ongoing phase III trial in the whole world with a disease-modifying therapy. And it's enough with a single pivotal trial aligned both with the EMA and FDA. Usually, you need two, but it's enough with one for us, which is a big thing for us and for the whole field. We are the first company ever that has been given the green light by the U.S. FDA to go for a potential accelerated approval in the U.S. based on an early readout in the ongoing phase III , which will happen around March, April next year. So we get the opportunity to lift the lid and look at the data in a blinded manner and not to compromise the study.
If it's positive, we can then start our interactions with the FDA to start preparing for an accelerated approval in the U.S. Last but not least, milestones, obviously a lot is happening and more and more is happening all the time, but we are on the last sort of dash now on the patient recruitment side for the phase III trial. Last update, I believe we gave in our previous quarter report. This was more than 250 patients recruited. We aim for around 300. We have our own in-house manufacturing of the recombinant protein where we are aiming for GMP Certification, where a lot of inspections are ongoing currently. Then the biggest thing is obviously early phase III readout, which is happening around March, April next year, which could then support an accelerated BLA in the U.S.
This is all done with a quite solid cash position. We were able to raise quite significant financing in the spring in a very difficult market, as we've heard here. We had no underwriters, but raised around almost SEK 270 million, with less than 5% in costs. Importantly, this takes us beyond the readout. We have warrants also end of April that could generate around SEK 300 million, more if these are successful. With that, I leave you with our latest slogan, "There is no insulin like your own," which really shows that yes, you can supplement with insulin, it works, but if you can preserve your own, that's the most important thing for the patients. Thank you.
Thank you. A couple of questions here, forward-looking questions about, well, if the phase III is successful, what is your strategy for commercialization?
Good question. So we have different options. We are, like, well, all companies here, I think, are in discussions with potential partners. Obviously, with phase III results coming up, those discussions are on a completely different level than they have been before. We also know that we can commercialize this on our own, especially Type 1 is such a, let's say, specific focus disease use, basically specialty endocrinology. So we know you don't need a really big sales force, for example, to cover the whole of the US. So we have done market research in the US and we know that's possible as well. It's also important when you are in discussions with partners, you should never be forced to partner.
But for Type 1, since we have orphan designation, we go for a genetic subgroup, it is a possibility for us to do this as well, obviously with the right kind of investments, but so we have both opportunities and obviously we will pick the one that is most attractive for shareholders and also that we can actually reach as many patients as possible.
In terms of markets, the U.S. is your number one, your priority market?
Yes, that's, I mean, that's where we have really alignment with the FDA now with the accelerated, and we've done most market research there showing with the peak sales could be around $2 billion US only for the first indication.
Are you looking at any other markets at the moment?
Well, Europe, obviously we have the trial ongoing in Europe as well. So U.S., Europe are obvious markets and then you have many markets that would come with these markets as well.
Some financial questions with the current cash position and the burn rate forecast. What contingency plans do you have if you need further capital ahead of commercialization?
Yeah, so the next, obviously, we have the warrants, like warrants of Series 5, which can generate quite significant amount of cash. We've been quite successful previously with some of our warrants. Usually you get 90%-95%. It's quite dilutive if your share price is above the strike price they usually are, but that can then generate quite significant amount of cash, which will carry the company further for a good amount of time. Then, with, especially with positive phase three readout, I mean, the company will transition into a different phase when it comes to also opportunities with large investors, for example.
You mentioned here, obviously, that you've been around for a while and failed phase 3 to meet the endpoint. Someone is just asking here, like, what is it, what's the main difference now that makes you sure that you will succeed this time?
So the biggest difference is, yeah, it's the patient population. So previously we treated broadly everyone who had like newly diagnosed Type 1 diabetes, and now we go for this 40% who have the right genetics. Because like I said, when you treat with an, it makes sense now and afterwards, we didn't know that and field didn't know that 15 years ago. If you treat with an antigen, it's picked up by the cells and then these small pieces of the protein is bound to receptors and then you get the effect. But you need to have the right kind of receptor to get the right kind of effect. So we choose the one who have the right recipe. That's it.
With that, we say thank you.
Thank you so much.