Company Interview / LTR Pharma's speedy relief

Key points:

Nasal spray Spontan absorbs 470% faster than tabletsSafety data shows fewer side effects, interesting FDA and TGALTR Pharma (ASX: LTP) targets global market with strong financial position.

Lee Rodne, Executive Chairman of LTR Pharma (ASX: LTP) shares insights on their intranasal drug, Spontan, which absorbs 470% faster than oral tablets. The drug aims to address erectile dysfunction by providing rapid results and fewer side effects compared to conventional tablets.

Lee states that faster absorption and fewer side effects of Spontan could fulfil an unmet need, as 50% of men stop using tablets like Viagra due to delayed effects and adverse reactions. He is excited about discussions with the FDA and TGA regarding the drug's safety profile.

Lee highlights the $7 billion erectile dysfunction market, particularly in the US with 30 million affected men. LTR Pharma (ASX: LTP) is focusing on partnerships and commercialisation, leveraging early prescriptions from Australia. The company is set for growth, aiming for direct-to-consumer marketing with strong financial backing.

Full unedited transcript below:

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Like our farmers shares. Let's see how they're looking today after it completed a key study for its novel intranasal drug, Spon ten, which showed that the drug is absorbed 470% faster than oral tablets. So we'll get the details on those findings and what it may mean going forward with Lter Pharma's executive chairman, Li Rodney. He's joining me now. Lee, hi. Welcome. Welcome back to ACS. Take us through this this clinical trial, what it did and what it means. Well, the clinical trial compared our nasal spray delivery technology, our nasal spray products, Fontan with a market leading, uh, um, drug for erectile dysfunction, a tablet. And we were able to show as you, as you mentioned at the beginning that we're close to 500% faster than the tablets. And that's pretty remarkable, uh, because that's one of the reasons why men stopped taking, uh, tablets like Viagra

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is because it takes a long time to to take effect at all, if at all sometimes. So it takes about an hour with the tablets to take effect. And and we've now shown that we are the fastest, uh, treatment for erectile dysfunction in the world. Okay, so that would make many people happy. Uh, what's the safety? Um, you know, any of the side effects? Like what? What are some of the perhaps unintended consequences of taking this kind of drug? Well, we're, uh, we're pretty fortunate because we're, you know, we have higher bioavailability within the tablets, too. So that means we're a much more efficient, uh, delivery technology, uh, than the tablets to. The tablets have to go through your stomach and your liver and your kidneys, uh, before entering the bloodstream. And that causes adverse reactions, uh, that the tablets have that we don't have. So the tablets may give more serious headaches. They may. They give flushing in your face. They may give, uh, heartburn is what quite common to get heartburn, uh, and back pain and joint aches with the tablets. And we didn't see any of those types of, uh, uh, safety issues with our, with our nasal spray because we don't

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go through the the stomach and the liver. Okay. It's pretty remarkable. Yeah. So, Lee, what does this mean then in your dealings with regulatory bodies? You know, with the FDA, with the TGA, for example?

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Well, you know, 50% of men stopped taking, uh, the erectile dysfunction tablets like Viagra, um, on market. So they take they stopped taking them in the first year because of the time that it takes to take effect and because of the safety issues that those tablets have. So we're quite excited about meeting with the FDA and TGA and going out, going over our safety clinical data that we don't get those same side effects. Uh, and we we meet an unmet need because, you know, the men are stopping, uh, uh, taking the pills, the tablets on market, uh, for a very serious issue, you know, once, once you reach the age of 45 years of age, over 60% of men, uh, experienced erectile dysfunction. So it's a very serious, very common issue, uh, that we're coming in with a better and more effective treatment. Yeah, and it's a physical issue, but it can also turn into a mental issue as well. So you're progressing these conversations with the regulators. Like how long do you have any sort of a timeframe. Yeah. So we'll be now now that we just released our

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final, uh, clinical data. Our regulatory teams, both in the US and in Australia, uh, will be packaging up our clinical data, uh, with the aim of meeting with, uh, with both agencies, the FDA and TGA, uh, later this year or early, early this coming year. So, so pretty quick right around the corner for us. We're pretty excited. Okay. And how are any conversations that you may be having around licensing or distribution agreements going? Well, we know it's a it's a very of high interest, you know, and the US market in particular, about every third or fourth commercial on TV is about erectile dysfunction drugs. Um, so it's a very, you know, uh, top of the market, um, you know, type of treatment that, that were, uh, that were going to market with and the world's first nasal spray technology. So, uh, we have a lot of interest in our in our commercial and partnering programs. This data is only going to support that even further, because we are truly the fastest treatment for erectile dysfunction coming to market. Do you have any idea of how big the addressable market is around the globe? And

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and does that inform your strategy of where you sort of launch next? Yeah. So it's a it's a it's a it's a it's a very large market. So it's, it's about a $7 billion market. In the US market. There's about 30 million men that suffer from erectile dysfunction. And that's, you know, quite similar around the world in terms of the percentage of the population. Uh, and so, you know, we're going to be tackling that US market, um, as well as the Australian market, Australia is really important for us. It's our home market as well. Uh, we're getting uh, early prescriptions in the Australian market, which means a great deal to us because it's given us that real world clinical data, uh, that we can use in our FDA processes, plus in our commercial partnering programs. Yeah. So it's been quite the, um, quite a busy time for you since listing on the ASX. When you think about in terms of, you know, balance sheet robustness, like strategically, where do you want to bring the company in the next, say six monthly?

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Yeah, certainly. Well, in the next six months we're going to, uh, do all the steps that we need to do to bring this product to market globally. Um, so we're going to get continue to get more real world data from early prescriptions here in Australia. We're going to set the company up for online direct to consumer marketing. So that's a lot of these drugs these for lockdown dysfunction are going online. Now about 70% of new scripts are going online. So we're going to build put in the building blocks uh to to go direct to consumer. Uh, we're going to be meeting with the TGA and FDA, and we're going to be influencing our partnership, uh, discussions with global pharmaceutical companies over the next six months. We we did a very successful capital raise just a few months ago. So we're in a very strong, uh, cash position, uh, to go through our next milestones over the next, you know, 12 to 18 months.