Hi, everyone, and thank you for joining H.C. Wainwright's 28th Annual Global Investment Conference. My name is Natasha Ray, and I am an analyst on the corporate access team. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to private and public companies across multiple sectors and regions. We have a total of 19 publishing senior analysts and over 650 companies covered across all sectors. If you would like more information, please visit our website at hcwco.com. As a reminder, please reference your online conference portal that provides your individual links to your meetings and all company sessions. With that, I would like to introduce Greg Gorgas, President and CEO of Artelo Biosciences. Thank you very much, and it is great to be back at the H.C. Wainwright Conference this year. For those of you who are joining by the webcast, welcome, and those that I will meet with you in person during the conference, I am looking forward to those conversations. Today, I will be presenting our corporate presentation about our pioneering lipid signaling modulation, and we are traded under the Nasdaq under the symbols ARTL. I am Greg Gorgas, the founding CEO of the company. I will be making some forward-looking statements today. I would invite you to please go to our website where all of our filings are current and linked on our website under the Investors tab at artelobio.com. During this presentation, I am going to introduce, for those of you who are not familiar with Artelo, a little bit about the company. We are a clinical-stage biopharmaceutical company, and we have a large platform of lipid signaling modulation drug candidates. I will focus in on three of those today and talk to you about our novel science. I will share with you the near-term catalysts or milestones that are upcoming. All of our assets are focused in on billion-dollar market opportunities that are underpinned with a very robust patent estate. I will share a little bit, time permitting, about the proven leadership team that is with me at Artelo Biosciences. As a quick overview, this is a snapshot of our three assets that I would like to share with you today. Those three assets, two are in-licensed, and one is our own invention. The first asset is a dual cannabinoid receptor agonist. We call that ART27.13. If you like nicknames, you can just name it 13. That was originally developed at AstraZeneca, and we licensed this in the worldwide rights in all fields at Artelo. The second asset that we will discuss, nicknamed 12 now, is ART26.12. That is a fatty acid binding protein 5 inhibitor. That came to us through Stony Brook University. Last but not least, 11, nicknamed or ART12.11, is our co-crystal of cannabidiol and tetramethylpyrazine that is in the preclinical. The other two assets are in clinical stage, and we will focus most of our time on those assets. Let us talk a little bit about ART27.13. This is that dual cannabinoid agonist that we have in development phase II for cancer anorexia. You might think, Oh, I do not really know a lot about cancer anorexia, or, I have not heard about it. But anybody that has been through the cancer journey does. Anybody that's been as a caregiver of somebody in the cancer journey does. Or if you can just close your eyes and think about Steve Jobs or Patrick Swayze or anybody else that you've known going or have seen on the internet or on television that has gone through the cancer journey. You can see them losing a tremendous amount of weight, and if they're destined to be treated, they need the energy to fight in their cancer. If they're not, they should pass through this experience with dignity. There is nothing FDA-approved to treat cancer anorexia today. Nothing actually approved in the U.K., nothing actually approved in Europe. It is really a global unmet need that we're trying to address. This is the molecule ART27.13. It's a synthetic dual cannabinoid 1, cannabinoid 2 full agonist. We dose it once daily, orally. It's a made-up drug, meaning it was invented at AstraZeneca. It does not mimic something in the cannabis plant. I want to be very clear about that, but it does target the same receptors that, for example, THC, which is a weak agonist, targets in the body. It doesn't mimic THC, but it does target the same receptors that THC targets. But in contrast to, let's say, THC, it avoids the CNS side effects by being peripherally selective or preferential to the periphery. It does leverage a well-known pathway, and that is around lunchtime, if you're watching this around lunchtime, you probably grabbed your gut region or your tummy and said, I'm hungry. That's because their gut region is filled with these cannabinoid receptors, and it sends a signal through the vagus afferent nerve to the brain, Feed me, I'm hungry. The drug doesn't have to travel to the brain. The drug actually needs to go to the targets in the gut region that sends the signal to the brain, and that's what our drug is believed to do. We are very excited to share with you data from our CAReS or Cancer Appetite Recovery Study. The schema for the trial is listed here on the slide in front of you. The phase I is completed. About 27 patients participated or were enrolled in that, in four doses on a dose escalation protocol. I can just summarize the data which we previously put out in former corporate decks, but about a third of the people at those doses continued to lose weight, about a third were stabilized, and a third gained weight. Again, the purpose of the phase I was to establish safety. It wasn't primarily to look at efficacy. But even at these low or subtherapeutic doses, still two-thirds of the people either stabilized or gained weight, and these were all people that had lost weight going into the trial. What I wanted to focus on today, though, is showing you data from our interim phase II data release. That is where we started from the phase I at that lowest dose, 650 mcg, elevated after a month to 1,000 mcg, and then to 1,300 mcg for those patients that were on that protocol. This was over three months or 12 weeks that patients received the drug. They were randomized either to placebo or to receive active drug on this dose escalation protocol. We looked at lean body mass, weight gain, obviously, physical activity, because it is no sense to eat potato chips or Oreos on the couch if you cannot enjoy life and experience with your family, or make it to the doctor's office and receive your chemotherapy or biologic therapy to treat your cancer. We looked at anorexia or the loss of appetite, quality of life, and safety. Let me share with you a little bit quickly about safety. Safety, like I said, was assessed in the phase I. 27 people participated. There were no serious adverse effects. There was some somnolence or drowsiness in 11% and dry mouth in 11%. You can see there is a lot of zeros on the table on the left-hand side of your slide there. On the right-hand side, you can see that the adverse events, there were, again, no serious adverse events. Remember, we dosed now up to 1,300 mcg. The safety profile observed in the phase II was very similar to that of the phase I. We would characterize this as very well tolerated, and the physicians that enrolled patients would say the exact same thing. Let us take a look now at how the trial is thought of and what took place. Then I am going to show you one more slide on the activity of the drug in the next slide. In order to get into the trial, you had to have documented weight loss of at least 5% over the last six months. What do you do when you go to the doctor's office? The first thing I still do is step on the scale. They do not do my height so much anymore. They all tell me to step on the scale. These patients had documented weight loss of at least 5% over the last six months. Then they are enrolled into the study. Again, over a three-month or 12-week period, the patients are put into the dose escalation protocol in the phase II. There is a safety washout period at the end where we assess safety. I think you can easily see by the slides that the patients that were on active drug gained weight. Those that were on placebo lost weight. At the end of the treatment, people started to go back to losing weight once they were off of the drug. Let us look at that a little bit more specifically on the left-hand side of your slide here. I think the real key message is what you can read at the bottom. At the end of treatment, there was an average of 6% weight gain in those patients receiving active drug that went up to the 1,300 mcg dose. Just for context, again, you had to lose 5%, or in my case, that would be about 10 lbs over the last six months. If I were on this trial and on active drug and had gone to the 1,300 mcg dose, I would have gained 12 lbs back. That is more than I actually lost in the last six months being treated for these last three months. Unfortunately, for those randomized to placebo, they continued to lose weight and lost an additional 5%. It is the difference in me weighing 202 lbs or being down to 180 lbs. I think that you can all agree that that is a very, very profound treatment effect. It is among the best that has ever been shown with a drug trying to treat cancer anorexia. I have been in the pharmaceutical industry for now four decades, always in the cancer space, and familiar with drugs that have tried to address this very big unmet need. Importantly, on the right-hand side of the slide, you can see that the activity for those that were on active drug also was increased in frequency, in duration, and intensity. It is very exciting to see, and this is because all the patients wore what we call an FDA-validated instrument. It is called a MotionWatch. You can think of it like a Fitbit or your Apple Watch, where it measures. Unlike your Apple Watch, it does not tell you to get up and breathe and do activity, but it does measure those activities, which is downloaded at the hospital or the physician's office. We were able to see all their daily activity over that three-month period. It was very exciting to see that not only the weight gain occurred, but it translated into what I would see as a very, very big improvement in quality of life. That is very exciting interim data to the phase II Cancer Appetite Recovery Study. That study is still ongoing, and we look forward to updating you on that trial in the near term. What is also very new and exciting at Artelo is the DREAM trial. I am going to switch gears completely here and say that the DREAM trial is in glaucoma. You now, Oh, Greg, how did you introduce this? New mechanisms of action are needed in glaucoma, and oral formulations are especially needed with an aging population that has difficulty with the eye drops. The cannabinoids have been shown to lower intraocular pressure through the cannabinoid 1 mechanism. Obviously, I said earlier, that is what we target, and also may offer some neuroprotection through targeting the cannabinoid 2 receptor. But cannabinoids have not really realized their promise pharmaceutically to treat glaucoma, largely due to buffering up against a toxicity or CNS side effects. Like you might think of targeting the CB1 or cannabinoid receptor through THC. But we have already just shown you in the CAReS trial that our drug is very well tolerated up to 1,300 mcg dosed daily. We think there is a really tremendous opportunity here. A world-leading ophthalmologist came to us and said, I noticed in your pre-clinical data that one of the sites of accumulation of your drug is in the eye. That could be very favorable. Two, you target the cannabinoid 1 and cannabinoid 2 receptor. Through his efforts, this world-leading ophthalmologist in Northern Ireland was able to secure funding entirely for this trial through Glaucoma UK, which is the largest charity for glaucoma in the U.K. This trial is completely funded outside of Artelo. It is a crossover design. It is a small pilot phase II, but people are enrolled and randomized to either receive active drug daily or placebo and then switch over and serve as their own control. We are looking forward to sharing the results of this study near year-end, hopefully before year-end, but if not, early in the first quarter of next year. I might remind you, though, that the dose in this trial is less than half of what we were giving at the top dose in the Cancer Appetite Recovery Study. Because you might think, wow, if it cures glaucoma, but if it makes everybody gain weight, that may not be preferable. If you also think about the elderly population, a lot of those suffer from sarcopenia, from loss of appetite, and some weight loss, even without the presence of cancer. Maintaining weight or even elevating a little bit of weight in these people, we would typically not see as a big risk for side effects. I would like to move on quickly to ART26.12. This is our fatty acid binding protein 5 inhibitor. I am switching gears completely, so just take everything I just shared with you and park it in the parking lot and think about the second drug in the clinic that we have, which is a fatty acid binding protein, and it is exactly what that is, how FABP was abbreviated. It is a protein that binds fatty acids. This really because fatty acids, you can think of omega-3 fatty acids coming into the body, is part of what cells use for energy. It is also what cells use for signaling. That is why on the slide in front of you can see the potential of inhibiting FABP5 is across the body in anxiety disorders, cancer, dermatology, and pain and inflammation. For us, the low-hanging fruit we believe is in pain and inflammation, and chemotherapy-induced peripheral neuropathy, or peripheral neuropathy, which is also in diabetic patients, but not caused by a drug, but caused by the disease, is a real serious problem. It affects up to 40% of people receiving chemotherapy. There is, again, nothing FDA-approved to treat that condition. We do not have the time in this short presentation, but suffice it to say, standard models of pain in seven studies that we did pre-clinically, all were positive for the drug to affect that. This is a cold plate allodynia model where like the cold tooth you have when you put an ice cube on it, the rats sit on top of a cold plate, and you see how long they can stay with their little paws on the plate before they jump off. You can see it is about a minute at the start of the study, and you can see by day 15, if you give our drug along with inducing a peripheral neuropathy, that they were able to stay on that plate longer at the end of 15 days than at the very beginning when they had not been treated at all. We have completed a phase I study. There are four key points on that. They are listed on this slide. This drug had an excellent safety profile. In fact, not one single toxicity attributed to drug was observed in the 55 people that have received this drug. It had beautiful linear pharmacokinetics, and anybody in drug development would know how important that is. The therapeutic window looks awesome. We dosed up to 1,050 mg, and the therapeutic dose looks to be around 200 mg, so we dosed approximately five times that of the therapeutic target dose. We can, through a preliminary food effect study, we believe, based upon that evidence, dose this in the fed or the fasted state, giving a lot of optionality. We do not have a lot of time to go through our preclinical asset. Just suffice it to say, we are targeting anxiety and depression. I launched a drug called XANAX a long time ago, and we are not treating anxiety and depression much better than we did when I, three decades ago, launched an important benzodiazepine in this area. CBD has been tried in this area. Ours is a co-crystal of CBD plus a co-former that forms a new crystal and lattice, that forms a new co-crystal. That allowed us to have better physical properties. For example, it is more resistant to heat, so we can compress it into a tablet. We have already made 100 mg tablets. Nobody else can do this. The pharmacokinetics is fantastic. We have compared this to Epidiolex, and it has won every single time in those models. The pharmacodynamics of the drug are excellent, and I can show you that in the next slide. More importantly now, I think it is in 22 countries, we have issued composition of matter patent protection on this, saying that is nice to develop a drug and then offer investors a return on the investment for that. We did do, and with this all, I will just invite you to go to our website and look, but we did compare about a third of the dose of CBD in our co-crystal to 10 mg, so 3.5 mg versus 10 mg of CBD in nine different tests around anxiety, depression, being in socially engaging and cognition, which are side effects often of those drugs like the benzodiazepines that I mentioned. In every case, we won. In all of those cases, CBD at three times the dose did not. We also compared this to the SSRIs in depression and came out favorable on that. You can see those press releases from last year. I told you I was representing a team, a team that knows what finished and good looks like. What I would invite you to do, if you are curious, is to look at our website where all the bios of our team are listed. I might mention Professor Richard Porter there on the bottom right. He and Professor Saoirse O'Sullivan, who is our vice president of translational research, sat in at Trinity College Dublin, where Professor Porter is, and discussed all three of our assets in some nice videos that are on our website. I would invite you to go take a look at that. From a capitalization perspective, we have just under 5 million shares issued and outstanding. All of the warrants and options are currently out of the money. We have cash and cash equivalents last reported at just over $4 million. There is no debt, no convertible notes, no toxic resets or ratchets in any of our financing. We are motivated to move this as co-owners with you, motivated to return investment as our value creation efforts are maturing. In summary and in conclusion, I hope I've been able to convey to you we have a very, very exciting novel portfolio, different mechanisms of action targeting different diseases, but all under the umbrella of lipid signaling. Very promising new therapeutic area. Near-term milestones across all of our programs. Again, targeting billion-dollar market opportunities. Why that's important is that it'll help us as we mature these assets, develop partnerships with global pharmaceutical companies. A very, very well-protected patent estate at Artelo. Again, go back and look at the team and see the leadership that I have the privilege of being surrounded with as we drive Artelo forward. Again, we're traded under the Nasdaq under the symbol ARTL. I would invite you to go to our website. With that, I hope you enjoy the rest of the conference. Thank you for participating and listening a little bit about Artelo's story. Thank you. Thank you, Greg, for leading a productive and informative presentation on behalf of Artelo. We really appreciate the time that went into putting this together and are very grateful for your team's participation in our conference this year. Thank you.
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