Very welcome Claus Elsborg Olesen, CEO Initiator Pharma. Please go ahead with your presentation.
Thank you very much, Claus. Happy to be here. Today I'm presenting Initiator Pharma and how we advance our innovative drugs for treating sexual dysfunction and pain. We are a Danish company. We are listed here in Stockholm at First North, Nasdaq. We have a market cap around SEK 200 million, and we are fully funded into 2027, and I'll come back to that, why that's important for us. We are supported by more than 3,500 shareholders and some of the cornerstone investors is Linc AB, we have Adrigo, and also MAC, which is actually the CRO that is conducting our clinical trials and invested us in numerous times and doing this once again in the trial that we are running right now. What are we doing? We're developing a pipeline of innovative monoamine modulating drugs.
Monoamines are serotonin, it's dopamine and norepinephrine. Actually, we can modulate these molecules that are signal molecules in the brains to target different indications. Our lead molecule, pudafensine, is primarily targeting dopamine. We are advancing that in three different indications. First of all, in erectile dysfunction of organ or organic origin, where we have phase two data. I'll come back to that. Right now, we are looking into neuropathic pain, where we are running a vulvodynia study right now. That is in women that are suffering from this devastating indications. We'll also talk more about that shortly. Last but not least, we have actually shown in preclinical animal models that our drug pudafensine also work for female sexual dysfunction.
What you can relate to in men, where we have erection problems, we can also have the same dysfunction, Hypoactive Sexual Desire Disorder in women and so on. Here, we have shown that pudafensine also works in preclinical models. We are developing a new monoamine modulator that is taking away all the risk that was previously known with these drug classes. Who are we? Well, we are a very experienced team that are advancing this, and I would just like to highlight today Mikael Thomsen, who's our Chief Technical Development Officer. He's the guy responsible for running the clinical trials that we're doing. He comes with a background in Novartis and also Novo, where he was head of clinical pharmacology for a number of years and has a lot of experience in running clinical trials, demonstrating proof of concept.
With him, [Susanne Thomsen ] is helping us with the clinical operations. They are very hands-on together with Ulf Simonsen. All the trials that we have, even though they're outsourced, we are on top of every detail in the trial, and that's how we ensure the best quality of the trials, and we're getting the best readout possible in these settings. Our strategy right now, both from a corporate and business development, of course, is maximizing the value of pudafensine and our other candidates in the pipeline. We do that going targeting strategic global pharma partnerships or regional partnerships, and you can say the key value drivers here is what I just have listed. That's the neuropathic pain program in the vulvodynia. It's the erectile dysfunction, either as a mono or combination therapy. I'll come back to that.
Also in the female sexual dysfunction, where we've shown efficacy in preclinical models. This is actually what we go out with and discuss with partners. We came back from JP Morgan in early January, and it was actually a whole different perspective for us coming back from JP Morgan this year. We saw a lot more interest in Phase II assets, also in the pain setting, in the vulvodynia, but also very much in the erectile dysfunction. Coming back to the erectile dysfunction, we will know that as more 400 million patients will suffer from this by 2030. About 30% - 40% of these do not respond adequately or cannot tolerate the current treatments, and that is Viagra or Cialis, what we call the PDE5 inhibitors.
What we are actually developing with pudafensine is a first-in-class drug that treats moderate to severe ED non-responders or non-tolerators of the current drugs out there. This market is continuing to grow. Even though it's very generic, we see a lot of lost profits and margins on the PDE5s, and that's where we see now an increased interest in actually finding new erectile dysfunction drugs out there. We are coming with something that is very unique, and I'll just talk about that briefly. Pudafensine is very unique in the way it works. We actually strengthen the natural erection function. We know that dopamine is the main neurotransmitter in the central nervous system that facilitates sexual motivation, copulation, and genital reflexes, and this is also true for women.
Actually, once we get stimulated, seeing something nice, being touched, we actually get a massive release of dopamine in the brain. Through a cascade where we have binding of dopamine to receptors, we have the production of neuronal nitric oxide, and we get a signaling down through the spinal cord that causes dilation of the blood arteries, meaning that blood can flow to the penile tissue, and we get the erection. This is very different from everything else in the market that is solely focused on, you can say, the peripheral part. We're actually going in and strengthen natural erection response by giving an increased level of dopamine in the brain. Very differentiated to what's out there. We have shown in the clinic in phase IIb, where we actually showed that we've reached the primary endpoint.
We can see this dual mechanism of action, where we actually both work on the central nervous system, also with a peripheral effect, are generating responses in patients. We are very safe. We have dosed it to more than 200 patients. We see that the doses are well-tolerated, and there is no CYP inhibition, so no drug-drug interactions with other molecules. Again, there's a unique market opportunity here with a lot of non-responders. We also see the combination potential. Taking a PDE5 and combining it with the pudafensine, you will actually bring in an even further segment into the market. That is definitely something we're also discussing with our BD partners. That will give strong patent protection beyond the 2044. What we are doing right now, we are continuing the efforts here on our business development.
We are speaking with regional but also global partners on how actually to best take pudafensine forward as a monotherapy, where we demonstrate efficacy, or as a combination product. We'll see how that comes in the coming months to quarters, how we can finalize that. Looking at the second part of the presentation today is talking about our program called Lierfem. Liberfem is a first-in-class revolution in vulvodynia treatment for women, and we'll just briefly touch upon this. What is vulvodynia? Do you know what vulvodynia is? Most people don't, because this is an unspoken pain indication due to a lot of stigma and also taboo related to that kind of pain. It is a severe debilitating pain that actually is in the vulvar region of the women.
It can be most in the cases where 85% of the patient suffers from what we call provoked vulvodynia, so upon touching, so that's insertion or walking or biking, and it follows a very temporal pattern. This actually significantly impairs the quality of life for these women. It's a debilitating pain that actually is giving them often mental health issues, sexual dysfunction, and in general just impact daily life. It affects more than 30 million patients in Europe and the US alone. There's no approved therapies out there. The economic burden is just staggering, yet alone in the US, more than $75 billion a year. What is very unique, even though this is a localized pain, actually studies have shown that this is actually a pain that is driven by the central acting pathways. It's not enough just to treat in the local region.
You need to go in and modulate the monoamines in the brain. That's exactly what we do with pudafensine. We have shown in previous studies that pudafensine works in pain in healthy volunteers. It's been shown that the kind of pain that exactly expired, experienced when you're using capsaicin, which we use in this model, is very similar to what we see in vulvodynia. This is quite unique. We actually bring something in here where we actually already now have seen that we can provide pain relief. Now we will do it in the patients. Right now, our mission is to deliver evidence pain relief data. How are we going to do that? First of all, we again using pudafensine. Pudafensine, as I talked about, has a really good pain relief profile.
I also mentioned that one of the most common side effects of suffering from vulvodynia is sexual dysfunction. You can actually saying here we're taking the two properties of pudafensine, the neuropathic pain data that we have, but also the sexual dysfunction data we have from the erectile dysfunction. We're putting them into a tablet, and then we're actually exploiting both of these to treat vulvodynia. Looking at the commercial potential, this is just huge because there is no approved therapy. Getting pudafensine approved in this indication and will be market leading from the get go. Here we kind of summed up the peak sales numbers in Europe, in Japan, and in the U.S. Depending on which territories you include, it's between $1 billion-$4 billion in peak sales annually.
A very large commercial opportunity. This is actually very much addressed. When we speak to pharmas, they acknowledge this, that it is an unmet need. They can see the potential here, but they kind of been focused on just treating the local pain, not going in through the central acting system that we are. This has give us a quite unique position here. Just what is it we are doing? Well, we are running right now a proof of concept trial with pudafensine in vulvodynia. This is a trial where we need to have 24 completers into the trial to get the power for the study. It's a four-way crossover. That means that each of the women come into the clinic will get into the clinic four times, and they will get three doses of pudafensine, high, low, or medium dose, and then a placebo.
This will be done in a randomized order and blinded, of course, nobody knows what's going on. We can say after that, we will experience the patients that come in. The primary endpoint is changing what we call the pain threshold with the Wagner algometer. It's a metal pin that you push against the vulva in specific areas, and then you, when it hurts, you measure how many Newtons you could press, apply pressure with. At the end of the day, we perform another test, and that's the tampon test. This is also validated by the FDA and the EMA as a true endpoint it is. We take the tampon, it's an insertion of a tampon, and it's a retraction again. You actually rate the pain on an 11-point numerical NRS scale.
Additionally, we will look at some, you can say, exploratory endpoints, where we look at patient outcome related to sexual function and pain in the days to follow the study. This is quite a good study because each of the patients will get three doses. We get the placebo, so we will take a lot of power into this and the women will be their own controls going forward. This study is ongoing, and we are seeing really good recruitments going into this study. We expect to read this out in Q4 of this year. Again, as mentioned before, we have financing until 2027, so we'll have the data well in advance of running out of money. Just in summary, what is it we are doing with pudafensine? Well, pudafensine in vulvodynia, it's a clinical de-risked drug candidate.
We've already validated the way it works in actually getting data from healthy volunteers in pain. We have shown that it actually has a benefit on the sexual dysfunction. It's an oral easy tablet to take, once daily dosing. What was really important when we're looking at pain, it's a non-opioid, it's a non-hormonal, and again, it's very safe. There's no drug-drug interactions or any other tolerability issues. There's a huge commercial opportunity here. With that, I would like to say thank you and look forward to take some questions. Thank you.
Thank you so much, Claus. Let's stay at the vulvodynia indication for pudafensine. You mentioned that the recruitment goes very well. How many women have you recruited so far?
We have not published that yet.
No
... but we will, we'll get you back to the market when we think we have a good portion in, and also when we have a little bit more idea when we will finish recruiting.
Is it possible to give some indication when you have to be fully recruited to meet your timeline?
Yeah. Fully recruited will have to be sometime in just after the summer to meet the timelines for having data in Q4.
Mm-hmm.
Yeah.
just looking at the pudendal nerve within vulvodynia, how do you look at this treatment if it would be approved? Would it be used as a chronic medication or for some periods?
No, it's a very good question, Claes. I think that most of the women that suffers vulvodynia, they will need to take it chronic, as a chronic treatment.
Mm-hmm.
We of course know there's a variance in how much pain they have. Some women only experience pain on put... in a sexual intercourse and so on.
Yeah.
That could be thought more of an, you know, on-demand use. For the majority of the women, it will be a chronic treatment.
Mm-hmm.
Yeah.
yes, to get it approved, what kind of clinical trials do you think you will be needed if this Phase IIa trial is positive, what would be the next step?
The Phase IIa trial, as I said, is a single-dose, trial. We double get the single dose, and then we.
Mm-hmm
... assess the pain just like we did in the capsaicin study. The next step, and that's really important here, we are looking for finding a partner to do this.
Okay
will be a chronic dosing over a period. In most of these studies in pain.
Mm-hmm
... 12 to 16 to 18 weeks as a minimum. We see this as a little bit different because we actually think if you cannot provide pain relief within, you know, a couple of weeks, then you don't have a product in this indication.
Mm-hmm.
We believe that you could actually get quite far in a Phase IIb with a four weeks dosing. We see this as a way to do something together with a partner that has an interest in women's health and neuropathic pain.
Mm-hmm
combined.
This would follow a larger pivotal study then?
Yeah. You would need to go into a phase III.
Mm-hmm.
Of course, right now in the U.S., there's talk about you just need one phase III.
Mm-hmm.
There had not been any announcement of how many patients. In this indication that is quite common, you will still need to do minimum 1,500 patients is our belief. We'll see how the landscape, the regulatory landscape evolves over the next couple of quarters here.
Yeah. Very interesting development-
Yeah
... I guess. You mentioned also you attended JP Morgan this year.
Yeah
... had some good discussions. maybe you could share a little bit, what kind of interest is there in female sexual dysfunction, but also in the ED indications today?
Yeah. If we start with the female part, in the female sexual dysfunction, that you can say that there's a lot of interest because they know this is a huge unmet medical need, right?
Mm-hmm.
It's again, 10% of all women are suffering from, actually FSD, or you can have, HSDD, so hyperactive sexual desire disorder. There's also been, you know, some products that have been partly developed, and approved for premenopausal women that have not been selling very well. One of them is an oral tablet you need to take every day, and the other one is injectable. We definitely there's been a little bit of negative around, these products.
Mm-hmm.
There is a need for a new product.
But-
Who's gonna take it?
Yeah, exactly.
I think that, you know, first of all, there's a, you know, majority of women actually end up spending most of their time living as.
Mm-hmm
... We need to find a treatment for them as well. We see that there is an interest from pharma companies, not only from small specialists, but also from larger pharma companies.
Mm-hmm
... that now are expanding into the women's health. I think that some of the larger pharmas are still a little bit, you know, tight on what they think women's health is. They look at endometriosis.
Yeah
... and that's pretty much it, right? I think that, you know, vulvodynia is just as common as endometriosis, and there's nothing approved.
Mm-hmm
... you know, nothing to do. I think we're still in the expanding phase, where we need to get more indication onto the women's health umbrella.
Yeah.
So.
Just to follow up then, and do you think this, phase IIa study would be sufficient to attract the partner interest? If you just could give sort of a ballpark guess, how large of a investment would a phase IIb study be?
I can start saying that there is actually interest.
Mm-hmm.
Of course, we discussed the endpoint in our ongoing Phase IIa trial.
Yeah
... with a lot of pharma companies, because doing a trial with endpoints that nobody believes in is never good, right?
No.
We of course vetted these endpoints, and we had discussions with pharma. We also discussed with key opinion leaders on what they would expect to see to be excited about this. Key opinion leaders that actually advise industry on taking on such assets. In that respect, we believe that the trial is very strong.
Mm-hmm.
Also, that we're doing three dose levels, trying to understand, you know, is there a difference in the response? Do we see a dose dependency?
Mm-hmm
... do we see us maxing out at one point, one of the doses that we're using? That is very strong design.
Yeah.
The next part of the study would be, as we talked about, a Phase IIb study.
Mm-hmm.
Since we don't have the data yet from this study, it's difficult to do the exact power calculation, but I would guess about 200 patients into such a study, a little bit depending on the design and how many dose levels you would do.
Yeah.
That we definitely see to do that as a chronic treatment over four.
Mm-hmm
... or eight or 12 weeks, we will want to do with a partner. You can say in a study like that, we'll probably be in the.
... quite, strong data-
Yeah
if that is a positive readout, of course.
Yeah, I believe that from the study we have now, we already shown with capsaicin that we could generate significant pain relief...
Mm-hmm
... with one dose, and that we will also see in the vulvodynia.
You also feel that the pain space is attracting partner interest?
Yeah, we definitely see a lot of.
Mm
In the pain space. We think that actually when we started out in this, we knew that our drug had good effects on sexual dysfunction, but also on pain. One of the reasons also to bring in the pain was because we wanted to create more interest around pudafensine.
Mm
... which is a very unique drug candidate that is very safe and well-tolerated, and we can definitely see the fruits of that right now.
Just jumping down to erectile dysfunction.
Yeah.
Where do you stand now? What, what's happening?
I think what's happening is that we saw in the past when we got out with the data...
Mm-hmm
... a lot of people thought, that looks really cool. With the Phase II data, you're shown that you can treat these moderate to severe ED patients.
Mm-hmm.
There was still a little bit of tendency, yeah, but Viagra and Cialis is still there. We have seen shift. People now acknowledge that there is, it's not helping them enough, that they need to find a new way. I think that also we can see that some of the companies that have branded products in their pipeline of PDE5 inhibitors are kind of losing a little bit of momentum now because.
Yeah
... people are stating slowly more and more generic. They see that a way to kind of, you know, protect that revenue stream is getting new IP in. Pudafensine is new IP, either as a monotherapy, as a combination with their drug. Definitely we see an increased interest there.
You have had some discussions around, ED indications for quite some time now.
Yeah.
Has anything changed that talked from a, give you a sort of a confidence that you are closer to a deal now?
Yeah, I would say that, you know, in the beginning we spent a lot of time on educating on why it was not enough to take a PDE5 for the patients.
Mm-hmm.
I actually think now that people understand that. They have seen the scientific rationale for having another product.
Mm-hmm.
They're start understanding that. We can also see that now they understand that the commercial value of that because they can see declining revenues and what they made profit on before.
Sure.
We feel that we are, of course, moving in the right direction. In the beginning, it was a very slow process. Now we can see that the discussions we are having is actually with more senior people in the companies that we're speaking to. Now it's up at the very top level in the company, and that's giving us a, you know, confidence in that we're actually moving in the right direction. We're actually getting the right stakeholders to the table that can say yes and no as we go forward.
Do you see some overlapping interest between ED and vulvodynia?
Yeah, you can say some of the companies that we're speaking to, some of, especially the larger ones, the global...
Mm
... pharmas, we see that they actually also often have pain products in their pipeline.
Yeah.
They actually, you know, when we start talking about ED and we discuss those things with them, we actually always come back to a vulvodynia trial. What have you learned there? What have you seen? Could we see the data again from your healthy volunteer study?
Mm.
We think that there's definitely an interest in both understanding what we can do in the ED, either monotherapy or a combo product, and then also in the pain segment. We definitely see that.
Do you think the next step for in ED will be a combination trial rather than a monotherapy trial?
Right now the discussions is, I think a split.
Mm-hmm.
We have some that just looking at monotherapy, and then we have the other combination therapy. I'm confident from a scientific point of view that both would work.
Mm-hmm
...because we have shown that it works by itself, but I can also see the rationale in going in actually, is strengthening Viagra, so to speak. Viagra can only prolong a natural erection. If you actually put pudafensine on it, you would actually get induced an erection, so then there's something to prolong, right? That makes good sense.
That's not the study that you will run yourself.
No, we, as we said before, we want to have a partner to do that because.
Yeah
... we want to find whatever. Is it gonna be used with tadalafil or what's called Cialis...
Mm-hmm
... or is it gonna be Viagra? Which of the combination products, so we need to find a partner who wants to promote their branded product here.
Yeah. Yes, then also I would like to just jump to IP2018. What's the strategy? What's happening?
In 2018 has been a somewhat different story.
Mm-hmm.
Even though you can see that the data we generated in the RidgeScan study.
Yeah
... in the depressed patients, we could definitely see that we got significant at the primary endpoints there again, and we are very happy with the data. We can just sense there's a little bit less interest in that. When we discuss ED 2015, pudafenin-
Uh-huh
... we also come back to 2018. Could that be used in the same manner? Could we do two things at the same time?
Mm-hmm.
Could there be a way to combine some of these effects of the compounds? That's something that we're still discussing.
Yeah.
Yeah.
Going forward in 2026, it's the readout then in vulvodynia.
Yeah
... and ongoing BD discussions.
Yeah. We are super excited about the next 12 months, right?
Yeah.
We're gonna have the readout in vulvodynia.
Mm-hmm
... at the end of the year. I'm very positive that will come out in a very positive way with the data we're already seeing in capsaicin study. I'm also very confident in the development, the business development activities we have on ED.
Mm-hmm.
The question is, can the product be used in both places?
Yeah.
Would it just be one of the winners taking it into ED or vulvodynia? Time will show.
Perfect. Thank you so much, Claus, and thank you for listening.
Thank you for the questions.