The next company here on stage is Initiator Pharma and CEO Claus Elsborg Olesen. Warm welcome.
Thank you very much.
The word is yours.
Thank you, and good afternoon to the ones in the audience and also online. As I've said, my name is Claus Elsborg Olesen. I'm the CEO of Initiator Pharma, where we are advancing innovative drugs for sexual dysfunctions and pain. We are a Danish company. We are listed here in Stockholm on the First North. We have about 3,500 shareholders. We also have some cornerstone shareholders in Linc AB, Adrigo, and MAC, which is the CRO that's actually conducting some of our clinical trials. At this stage, we are financed well into 2027. What we are advancing is a pipeline of monoamine modulating drugs. Monoamines are neurotransmitter molecules that are found in the brain. They are called dopamine, serotonin, and norepinephrine. They are involved in many signaling processes such as emotion, memory, pain, and they are really good drug targets.
We've been targeting these, the modulation of monoamines for many, many years. However, the first generation of these drugs have also some side effects. They get too much of one of the monoamines. For example, people that are getting antidepressants often develop sexual dysfunctions, and we also see cardiovascular complications with some of these drugs. What we are doing in Initiator Pharma is that we are advancing the next generation monoamine modulators, where we can very safely modulate the monoamines that we need for efficacy. Today, we're gonna talk most about Pudafensine, which is our lead candidate. Pudafensine primarily acts through dopamine. We have shown that dopamine works in erectile dysfunction. I will get into that in a minute. We have Phase IIB data in 130 patients.
We have also shown in a previous clinical study that we have really good pain relief in pain with Pudafensine. Now we actually have an ongoing Phase IIA in a pain indication called vulvodynia. I'll speak briefly about that as well. We have also shown that the drug of Pudafensine has similar effect on sexual dysfunctions in women, but we have only shown this in preclinical animal models. We have multiple inflection points coming up over the next 12-14 months. The company is run primarily by this group of people, and I would like to highlight two today. Michael Thompson, who's our Chief Development Officer, who's actually running all the clinical trials that we do. What is different, even though we are a small company, is that we are involved in every stage of the clinical trial.
We look at all the patients coming in. We look at their biometrics. We understand who is it actually we include in our trial, and we have many meetings during the week as the trial is conducted. Michael has a lot of experience from Novartis and Novo Nordisk in this, and he actually did his postdoc with the FDA in the U.S. on toxicology. He's very much supported by Ulf Simonsen, who's our CMO, who's an expert in sexual dysfunction and pain. Together with Michael, they make sure that our trial is living up to the standard that we want and also ensuring that we get the best possible readout of these trials. Just briefly on our corporate and business development strategy, the year has begun really nice.
We came off to a strong start, attending JPM, where we can definitely see a lot of increased interest in the programs that we are running. Right now, our strategic focus is targeting either a global or regional partnership with a big pharma player. You can say the three value drivers that we are sitting on right now is the ongoing neuropathic pain in the vulvodynia indication that I talked about. I'll come back to in a minute. Also, we see that the data in erectile dysfunction is getting somewhat a revival. People are really interested both in the mono therapy efficacy of the drug and also the potential to combine it with other existing erectile dysfunction drugs in the market.
We have also seen some interest in actually in the female sexual dysfunction, which is the same kind of, you can say, response that we see in erectile dysfunction, where we increase the blood flow to the genitals, but just in the women in this case. These are the key value drivers that our business development is going on for the time being. Just briefly on erectile dysfunction. We know that more than 400 million men are gonna be suffering from this by 2030, and we know that there's already some really good products on the market. However, 30%-40% of the patients out there do not respond to the current therapies. Current therapies are what we call the PDE5, so Viagra and Cialis.
We are developing Pudafensine as a first-in-class therapy for moderate to severe erectile dysfunction patients that do not respond to the standard of care, giving us the opportunity to win a specific market segment and also get premium pricing for our product. We can see overall that the ED market is growing despite that many of these molecules are becoming generic. We definitely can see that this is driven by more patients that are actually suffering from ED, but also that more people are getting aware that there is medications out there to be had. We look definitely into a very attractive positioning by going after the 30%-40% not responding at this stage.
I've shown this slide a few times before, but it's really important to understand why are we differentiated from the things that are currently in the market. We can say in one sentence that we are strengthening the natural erection response or sexual response, because this also is true for women. Dopamine is the main signal molecule in the brain that facilitates sexual motivation, copulation, and genital reflexes. The way it happens is that when we see something nice or we are being stimulated or remember something nice, we get a massive release of dopamine in the brain, particularly in the region of the brain that we call the paraventricular nucleus, which is called, publicly speaking, the sex center of the brain. Through a signal cascade, this increased dopamine relates all the way down to the penile tissue where we get a dilation.
A dilation means an opening of the blood artery and more blood can flow into the penis and we get an erection. We actually, we're targeting, you can say, the central nervous system to do this. We have also shown that our molecule has a peripheral effect. You can speak about the PDE5s and the Viagra and the Cialis. Practically speaking, they can only prolong a natural occurring erection. We can actually induce it, and that's where we are differentiated. We can help the patients that do not get this in the first place. A very unique method. What we have shown actually is that in the clinic, in the phase IIB study wherein 130 patients, we met the primary endpoint showing that we can actually strengthen the natural erection response.
We can do this with this dual mechanism that I just talked about, the central and the peripheral effect. We also saw from that study that even within the order more than 450 doses administered to 200 subjects actually were very well-tolerated, and we saw no significant side effects, which of course is important for a drug that you take for sexual dysfunction. Also, there's no CYP inhibition, and that means there's no drug-drug interaction. That means that even if you take other medications at the same time using our product, you will not have an effect of that. We can see again, as I talked about, the market opportunity is quite large, 30%-50% up to in, for example, patients with diabetes.
We can also see there's the combination potential of combining an existing PDE5 inhibitors with our drug. That's something we're also exploring on business development discussion. This will give us a IP beyond 2044. We have a really strong IP portfolio protecting this. Right now, as I said, on the business development, we are progressing nicely both on the monotherapy and the combination therapy within the ED space, and we look forward to update the market on this in the coming future. The second program that we're using Pudafensine for is Libafem. Libafem is in the women's health space, where we're looking at a neuropathic pain condition called vulvodynia, and I'll come into that in the next couple of slides. Do you know vulvodynia?
Actually, most people don't, because it is one of these pain indications that nobody speaks about. I think that pretty much anyone have heard about endometriosis, even though, you know, this is just as large indication. What it is actually a pain that is a severe, debilitating, chronic pain in the vulvar region for the women. It often is provoked, meaning that about 85% of the patients, they can get it provoked by bicycling, walking, or inserting a tampon or having a sexual intercourse. Even though this is a, you can say, a localized pain in the vulvar region, it's been shown that the pain is actually driven by the central acting pathways. Sorry. That is why we actually need to develop a drug that is actually acting on the central nervous system.
This is exactly what Pudafensine does, and that is also what we have seen in the previous clinical trials with Pudafensine. These women, they actually substantially impact, have impact on their daily life, on their mental health, and also on their sexual function. One of the highest reported, you can say, side effects of suffering from vulvodynia is actually reduced interest in sexual intercourse. It affects more than 31 million women in the U.S. and Europe alone. There's a lot of patients out there, and there's no approved therapies in the market, and there's nothing that works effective. Opioids has been tried, hormonal treatment has been tried, and none of them work. There's an acute unmet medical need here, and this is where Pudafensine comes in. The annual economic burden in the U.S. is more than $75 billion.
Right now, our mission is to deliver real evidence-based pain relief in patients suffering from vulvodynia. Just briefly, I talked about that our compound has shown previous before that it works in pain, and we have shown that it works in pain in a, what we call a healthy volunteer capsaicin study. We also know that it works under sexual dysfunction, and you can say in the vulvodynia program, we'll benefit from both of these characteristics of Pudafensine. Actually, both getting pain relief but also supporting the sexual function. Very, very important for going forward. Just looking at commercial opportunity, this is very large. As I said, there's nothing approved, so an approval on this indication would be you'd be the first approved and be market leading from the get go.
Looking here, we are actually taking very conservative estimates on market penetration, 10% of the market, of the women suffering from vulvodynia, and also prices that are at a lower price range of what you could take for new medication in this area. Depending on if you get approved in all the four territories mentioned here, you're looking between $1-$4 billion in annual peak sales forecasts. Quite a significant opportunity. Just what is it we are doing right now? Of course, we need to show this work, and the way we're doing it is actually we do a randomized, double-blinded, placebo-controlled, four-way crossover study in women suffering from vulvodynia. What we mean with four-way crossover is that you can see there's 24 patients that need to complete this study. They will go to the clinic four times for dosing.
They will all receive a placebo, high, low and medium of Pudafensine in a blinded fashion, and then we'll measure. What we will measure, we will measure change in pain thresholds using a Wagner algometer. That's a metal pen that we push against specific parts of the vulva and measure how much pressure can we apply before it hurts. Second, at the end of the day, we are gonna do the tampon test. The tampon test is, what it sounds like. It's an old, first generation tampon you insert and retract, and then you rate the pain on the NRS scale. What we actually can see here again is this is actually validated endpoints by the FDA and EMA. This is something that is used.
Of course, we're also gonna look at exploratory endpoints on pain settings and also on sexual function and so on. The primary endpoint is where we can measure the pain directly. We expect to have the readout of this trial at the end of this year, so in Q4 2026. Looking forward very much to see this. The trial is enrolling patients. We get good numbers in, and we have a good deal of interest in actually joining this trial. There is definitely a need out there. Just to finalize my talk, I'll just kind of highlight the summary of what we are doing with Pudafensine in vulvodynia. Again, we are taking a clinical de-risked drug candidate. We have shown that this drug is safe to administrate in patients and in healthy volunteers in the male studies.
We have also shown that it provides pain relief in the capsaicin setting that we've shown before on just one single dosing, and that's why the study is designed as we have shown today. Again, the clinical readout is coming in 2026. There's a difference in the way we're gonna administer this drug. For ED, it's gonna be an oral tablet on demand. When you need the support for the sexual dysfunction, you take a tablet. For vulvodynia, it will be a daily chronic dosing with an oral tablet. What's really unique about the Pudafensine is that it actually it's a non-opioid, it's non-hormonal, and again, it's a very, very safe drug to take in. We know that a lot of these women are also taking a lot of other medications, and that's why we don't wanna have any drug-drug interactions.
There's a huge commercial opportunity here, and again, estimating that the peak sales worldwide in the core territories mentioned could be more than $4 billion a year. With that, I would like to say thank you and looking forward to take questions.
Thank you so much for the presentation here. You mentioned the clinical readout here in 2026, but what other important milestones should investors, so to speak, look for in the coming 12 months, maybe?
Yeah. Over the next 12 months, we are working really hard to conclude on the business development with both within the ED space but also in the pain space. We could see that now, you know, at previous times when we came with our data in the ED space, we had to educate a lot of the big pharmas on why there was a new need. We actually think that they now kind of went back and actually saw they are right. Now we see an increased interest in, again, in discussing ED, both as a monotherapy but also as a combination product.
In the pain setting that we announced not that long ago, we can actually see that we get a lot of new companies coming in that actually are interested in pain, not only in women's health and Vulvodynia, but in neuropathic chronic pain in general, where we know that dopamine plays an important role.
I think I saw it on a slide there that you look forward to start discussions with partners. Is there a typical partner that will be very suitable for you, or are you looking at the broad spectrum right now on big pharma, or could you specify that a little bit maybe?
Yeah. You can say that it's a little bit different partners for the two programs that we're running.
Yeah.
Let's start with the women's health. There is actually both a global and strong regional players in the women's health, both in U.S., in Europe and in Asia. Particularly in Japan, there's some strong women's health companies as well. You can say that kind of facilitates maybe some more regional discussions in the women's health space, but also here we have the global players in discussion. Looking at the EDs and then you can say following up from the.
Mm-hmm
From the vulvodynia, there's also, as I said, mentioned companies that are more interested in neuropathic pain in general. It doesn't need to be a women's health indication. We're also talking with, of course, and wanting them to see the pain relief we provide because they all acknowledge that there's a large unmet medical need in vulvodynia. We think that most of the reason why other companies have failed is that they kinda looked at it as a localized pain.
Yeah
Instead of acting on the central nervous system. Going over to the ED companies, they are a little bit fewer. One of the primary reasons for that, of course, it is the PDE5s are now generic, so there's a, you know, no low profit margin on a lot of these compounds. But there's still a few players out there that actually has this as a big part of their franchise, selling branded products, but also actually having good sales channels both in Asia, in Europe and also in the US. Here we see that there's interest, and we can definitely see that the interest also in the vulvodynia part has helped them to maybe come more to the table here in the discussion, which we were hoping for when we did this.
I understand. You talked a bit about it now, of course, but you also mentioned now that a lot of others have failed in this area. If you would pinpoint what difference you from competitors in this area, so to speak.
Now we talk about the ED?
Yeah, yeah, exactly.
Yeah. You can say that the invention level in ED has been very low ever since the Viagra tablet. Pfizer tried to develop a drug that actually was a dopamine agonist, so it binds to the receptors of the dopamine. They actually could see that that's actually helped with the erection response. However, it also gave a lot of nausea and vomiting in the clinic, so they could not safely develop that. For us, it validates that dopamine, as we have also shown on the slide, is actually the main neurotransmitter driving the sexual response. However, there's not been a safe way to do that, and that's actually what we have.
We go in through the central nervous system, and we modulate the dopamine levels, and we do it with a reuptake inhibitor that gives us the advantage that it has its largest efficacy in the parts of the brain where dopamine is upregulated upon, you know, stimulation. That gives us a very unique position. You can say the majority of the compounds in the pipeline for ED is new formulations of PDE5s working in the same mechanism, faster onset, but they will never be able to address the 30%-50% not responding to the current therapy.
Looking a little bit, how do you prioritize your resources between the projects here? Is it, you have to pick one just, a little bit more, or can you be flexible in both or?
I think at this stage you can say right now we don't have any clinical activities on.
Yeah
Pudafensine in ED, so we are sitting on the data but of course spending a lot of time on the business development with that. We also know from the women's health that there's a large interest in this. We have spoken to companies, pharma companies before kind of validating the endpoints that we're gonna show, the number of patients and the power of the study of course trying to make sure that we actually have a viable product to sell at the backside of this. I would say that right now we spend most of the clinical resources on developing it in vulvodynia where we need data.
Yep.
You know, we don't have any data in women.
Yep.
That is what we need to continue the discussion. You can say we have a lot of companies that we need to revisit as soon as we have the efficacy data coming out of the vulvodynia study. We'll increase the business development on that, just like we have been doing on ED ever since JPM as well.
You correct me if I'm wrong, but I heard you say that you have cash run rate until 2027.
Yes.
How far have you hoped to come when by 2027, and what are your potential options for more financing, by when to 2027, would you say?
Yeah. I've been very clear from the beginning that if we want to do something continued in the ED space, a phase II extension either as a monotherapy-
Yeah
As a combination, we want to do that together with a pharma partner. That's because these studies tends to get rather large, and we think that, you know, we can do a lot of that with our team, but the investment is gonna be significant and we feel that it's better to achieve through a partnership with a pharma player that also can support, you know, the clinical operations. You can say that is what we expect to do in the before 2027.
Yep.
Having a deal, a partnership on advancing Pudafensine in ED, either as a mono or as a combination product. Then you can say in the women's health, in vulvodynia, we expect to have the clinical trial concluded, as I will say at the end of 2026, have the top-line data, and then we will have plenty of time to go out and revisit all the pharma players that we had talked with. You know, some of them can go in early, so they would like to be a part of planning a Phase IIB. Some of them are maybe gonna be supportive and say, "Okay, we can contribute in some of this," but you still need to take on the risk of advancing it in a Phase IIB study.
You showed the numbers of a pretty big addressable market.
Yeah
In both areas. Which market will be closest for if you look ahead here, you know, for a commercial launch for you? Is it the U.S.? As you mentioned, Japan, I think. Which will be the, so to say, prioritized market to launch in, would you say, in the future?
We can see, for example, in the U.S. market is very much of course, powered by a lot of generics in the ED space. We can see that in the Asian market, so Japan and China, there's actually a preference for using products that you know. Actually, Cialis and Viagra are still selling out there. We think that maybe there's a higher interest in getting products that have a differentiated mechanism of action.
Yep
In those areas. That is supporting that. We know that of course now there's a lot of debate on what drug pricing should be in the U.S. Again, we are coming out with products that are not in the very expensive ballpark as some of those that are being discussed. I still think that the U.S. is the primary market within vulvodynia and pain. The ED space, it could also be a regional deal in China or Asia in general. I think that overall we are opportunistic in that way. We also see that potentially in the women's health space, there's more regional players. Maybe we could structure a deal with some of these together and actually cover globally but with two or three partners in such an agreement.
If it hasn't been clear after your presentation here, to just sum it up a little bit, why should investors take a closer look at you as the next potential investment, if you were to boil it down, so to speak, right now?
Yeah. I think what we have shown is that we actually have Pudafensine which is quite a unique drug candidate. It has efficacy, and it's very tolerable, and it's safe. That means that actually we have a molecule that actually will work in either erectile dysfunction or in pain. Those, you can say there's a commercial large opportunity here. We are approaching an inflection point in the vulvodynia trial within the next, you can say, three quarters. Very excited on that. We also feel very comfortable about advancing a partnership on the ED space. That's why we think investors should invest in us.
Very exciting with the clinical readout in 2026 here later on.
Yes.
Big thanks for joining Stora Aktiedagen, and best of wishes to you going forward.
Yeah. Thank you very much for the question.
Thank you.