Video Transcription
Laurent Laferriere 00:02
Hi, I'm Laurent Laferriere, and I'm the co-founder and CEO of Ditch Labs, and we're solving the leading cause of preventable death, which is nicotine addiction and tobacco use. So smoking is still, today, the most important public health problem we are facing. It's actually the leading cause of preventable death, like I just said, in the US, and it affects 34 million Americans, and it costs $600 billion a year to the healthcare system, and causes just under half a million deaths. To put things in perspective, it's about 10 times as deadly as breast cancer. What's interesting is that the majority of smokers are willing to quit smoking. They're looking for ways to quit smoking, but unfortunately, they're not succeeding at it, and the reason can be essentially summarized with this graph. When we look at the PK of the nicotine that's delivered by traditional cigarettes, it really creates the spike that we're seeing with the yellow line here. But when we're looking at the PK of the most popular nicotine replacement therapies available, so the patch and the gum, for example, the red and the green lines, we're seeing a completely different profile, which creates a very ineffective replacement when we try to replace the nicotine, because it's a nicotine replacement therapy, from the cigarettes to those nicotine replacement therapies. When we're looking at vaping, it's twice as efficacious as nicotine replacement therapy. And the reason is pretty simple. We're looking again at the PK, and vaping devices are able to mimic the PK of traditional cigarettes very, very precisely, which creates a better experience for smokers and in turn creates a higher efficacy rate. So it's no surprise that vaping is the most popular option among smokers to quit smoking. But obviously, as we know, there's a bunch of problems that come with that. First of all, the vaping devices are regulated as tobacco products. Physicians are afraid to recommend those products because of the tobacco association. Obviously, there's a risk for sustained addiction. So what we're seeing is, although it's very efficacious to quit smoking, we're seeing people using vaping staying addicted to vaping forever afterwards, which is a big problem. And there's obviously a risk for abuse, as we're seeing in the media, mainly among teenagers, and the toxicology of those devices is variable, not to say unknown. So at Ditch Labs, we essentially took the popularity of vaping and the potential of vaping and turned it into a medical product, and we created the first vaporized nicotine replacement therapy that's designed specifically for smoking cessation. So our Ditch pen is a patented nicotine replacement therapy that precisely delivers nicotine and that has the ability to reduce the doses of nicotine automatically and seamlessly, to wean the user off nicotine. Our app is paired with our device. It acts as a psychological support tool. It contains motivational and informational content, as well as exercises and collects a bunch of data from the device to address the psychological side of the addiction. As a company, we're uniquely positioned to gain market share from two very big markets. First of all, the nicotine replacement therapy market is a $2.4 billion market growing, let's say, slower than other markets. But we're also positioned to tackle the vaping market, because half of people who vape actually vape to quit smoking. So if we're offering them a better product, a medical product, we hope to capture a part of this market as well. Since our founding just four and a half years ago, we've made incredible progress with minimal investment, so as a well-funded, but not necessarily huge rounds of funding. To date, in 2020 we launched the company, we've done a bunch of prototype iterations. The following year, we reached a proof of concept, raised our first initial round, a pre-seed round of a million dollars. In 2022 we finally completed the app and device integration. So essentially, the whole treatment, both products, and then we've also done pre-clinical validation, so we assessed the toxicity of our device in a lab setting, which came back with very positive results. And then we raised $2.4 million seed last year, acquired IP assets from our main competitor, and we're now ready to manufacture. All the partnerships are in place, whether it's GMP or ISO 13485 for the device. And then we're ready to start clinical trials. As you'll see, our clinical plan has been really driven by regulatory tailwinds in the UK. So we're focusing on the UK first. We're doing a bioequivalence study at the beginning of 2025 which will enable market access for us. So it's a very, very short regulatory pathway, which is kind of new. It's been only about a year that the MHRA has released guidance, and then we're following on after this. After this, phase one in the UK with our US pathway as animal testing will be done afterwards, which is kind of a bit weird in a way, but it's really the simplest way, and the fastest way we found, to get to market, and we'll also do a phase two, three in the US to get FDA approval by the end of 2026. Our go-to-market strategy, like I mentioned, is enabled by regulatory tailwinds. So we start with the UK. It will be sold behind the counter in pharmacies. We are looking to partner with large pharmacy chains, so we're initiating discussions in that regard. So if you know anyone, please reach out, and we will continue with a phase four pharmacoeconomic study in the UK to justify NHS reimbursement, which is very important in our go-to-market strategy. We also confirmed the paid pilot project in Saudi Arabia with a large partner there. So we're also looking at Middle Eastern distribution by the end of 2025, and like I mentioned, we'll follow on with the US and the rest of the world. Just to note, our regulatory pathway with the FDA is an NDA per 505(b)(2). We are a drug-led combination product. We, as I mentioned, acquired our main competitor's IP assets. So it's giving us 23 patents right now, 17 of which are granted in about 15 countries in the world. So a very, very interesting IP positioning that protects our innovative technology, our ability to dose any active compound by vaporization precisely, and also gather a bunch of data, very important data. Our business model is designed for reimbursement, which is again really critical to our go-to-market strategy. So our treatment is about 12 weeks. It's about $1,000 per patient, twice the cost of current nicotine replacement therapies, but we're expecting to be at least twice as efficacious, so the cost is justified. This gives us about 80% gross margins, and our Ditch app will be free. And there is also, we're looking at inserting consultations into the Ditch app, because consultations are usually reimbursed in the reimbursement models across the world. Our higher barriers to entry enable monopolistic growth and margin. So we're looking to be profitable by 2027 and hopefully reach $54 million in sales by 2029. Our team is myself as co-founder. I am a serial entrepreneur. I launched my first company in 2014 and exited in 2018. Christelle, our chief scientific officer, is an addiction psychologist, a serial entrepreneur, and a hardware engineer, and Dr. Lieberman is our CMO. He's a pulmonologist and thoracic surgeon trained at Harvard. Our team is advised by the world's top experts in smoking cessation, Dr. Benowitz at UCSF, Dr. Regatti at Harvard and Mass General Hospital, and Dr. Selby at CAMH, the Center for Addiction and Mental Health in Toronto. We're raising $3 million to reach UK and Middle Eastern commercialization, of which $1.5 to date, I think $1.7 since this morning is actually committed, so about $1.3 left in the round. And these are our current investors. We love them. We also have doctors with us, so we also love them, and they advise us on a daily basis. So if you're interested, please join us on our mission to solve the leading cause of preventable death and make the world a better place. Thank you. Applause.
