in our healthcare equity research team. Our next presentation is by Greg Gorgas, President and CEO of Artelo Biosciences. Artelo is a clinical stage pharmaceutical company developing novel therapies for anorexia, cancer, anxiety, inflammation, and pain. With that, Greg, please take it away.
Thank you very much, Vernon, and thank you for all the attendees at the H.C. Wainwright Conference for coming to Artelo's presentation here. We're very excited to share with you the story of Artelo. Some of you that are new to the story are going to get to see the entire picture. Those of you that are familiar with the story will probably see some new insights, so I invite everybody to stay for all of what I have to share today. We are a company that's listed on the Nasdaq under the symbol ARTL. I'm the founding CEO, and I'm thrilled to be able to share with you our pioneering science in lipid signaling modulation. We're developing novel therapeutics, as Vernon shared with you. I will be making some forward-looking statements.
All of our SEC filings are available at artelobio.com, as well as a lot of other helpful information. What I hope to convey to you today is five main highlights. One, that we have novel science and a very, very interesting drug pipeline. That there are near-term catalysts over the next six, 12, and 18 months that should be value-driving catalysts. We're going after billion-dollar markets, and why that's important is because that makes us attractive, not only for investment, but also attractive for partnerships with global pharmaceutical companies. We have a robust patent estate. You would expect that. That's the price of entry in this industry. And a proven leadership team, myself with 38 years of biopharmaceutical drug development and commercialization experience, and I've tried to bring in the best of who I've worked with over those years to support the effort at Artelo.
What I'll be sharing with you today, and we'll do a deeper dive, so we won't spend the time on this slide, but this is just a snapshot of Artelo's pipeline, our lipid signaling modulation pipeline, and the lead program, although we go under ART-2713, for the purposes of this conversation, I'm just gonna speak about the highlighted number at the end, the 13 program. This is a benzimidazole derivative that we currently are enrolling in a phase 2 for cancer anorexia-related weight loss for cancer related anorexia or weight loss. This was originally developed by AstraZeneca, and we fully licensed this asset into Artelo some years ago.
We completed a phase 1, which gave us the starting dose, a safe starting dose for the phase 2, and now we're enrolling in a randomized fashion against placebo and looking forward to that data early next year. The second program is our 2612, or also known today as the 12 program. This is a fatty acid-binding protein 5 inhibitor, originally developed with NIH-funded money at Stony Brook University. It's actually the first fruits of many in our pipeline of fatty acid-binding protein inhibitors, and we'll share with you the exciting developments here. But most notably, within the last two months, or last month actually, we were cleared by the FDA and given permission to start human studies. This is our own developed program, along with Stony Brook, and we're excited to bring that into the clinic.
The third program, which we expect to enter the clinic early next year, is our CBD-TMP co-crystal, a proprietary compound, that is at Artelo. This is our own invention, speaks to the credibility of our team. We have an issued patent estate around this, and some data that I'll share with you, towards the end. What's exciting for me, in small biotech companies, usually there's one or two catalysts, maybe, per year. But as we look in the periscope over the next, I said, up to 18 months, we expect no less than four major clinical milestones for the assets that I just shared with you. The data, from the CARES trial, which I'll share with you in just a minute, is expected in the first half of next year.
In the first half of next year would be the first single ascending-dose study results from our phase 1 with the fatty acid-binding protein 5 inhibitor, and then also the multiple ascending dose in the second half of the year, as well as the phase 1 data from the CBD-TMP co-crystal. Normally, you put a stack of chips down on a and you're looking for a binary event. In our case, we're looking at four, no less than four events next year, which is unprecedented in our history, and I think really remarkable in our space. Let's talk about the 13 program right now for cancer-related anorexia. So this is Mick. Mick was a participant in our phase 1 study.
That's a quote from him, Mick, on the page, and he says, when he pulled his trousers up and they fell right back down to the floor, "That was scary." That's not unusual for cancer patients. In fact, 60%-80% of all cancer patients suffer from this profound weight loss. It could have been Mick on this page, but it could have also been Steve Jobs or Toby Keith. It could be anybody that you recognize that has gone through the cancer journey, including my own mom. And the profound weight loss is hard for the family members, whether they're gonna be in the journey that ultimately they succumb to, or they could recover from the journey. They need the strength to have a quality of life and the strength to fight their cancer. And there is nothing FDA-approved to treat it.
By the way, in the U.K., there's nothing approved in the U.K. to treat it. There's nothing approved in Europe to treat it, and so we think we're doing something really important for cancer patients with this asset. And so what is our asset? 2713, or the 13 program, it's a benzimidazole derivative. It targets the cannabinoid one and the cannabinoid two receptors. Now, if I say the word cannabinoid, you might be thinking of cannabis. This doesn't actually come from cannabis. It came from the rational drug design efforts of AstraZeneca. It's a full agonist, unlike, let's say, THC, which also targets those receptors. It's a new chemical entity, again developed at AstraZeneca. It's peripherally selective. That's a very distinguishing feature, in that it does not cause the psychoactivity or the high or euphoria that you would normally associate with cannabis.
It's exactly what cancer patients would want. "Give me the hunger, but not the high." And last of all, it's orally dosed once a day, and that's because it leverages this really important pathway that we all live with. In fact, if it's lunchtime, when you're observing this, you probably grabbed your stomach and said, "I, I'm hungry," and that's because in the gut region are these cannabinoid receptors that send a signal through the vagus afferent nerve to the brain that says, "I am-- feed me, I'm hungry." And so that hunger stimulus is what we're trying to do. This was the data that AstraZeneca saw, that got us very excited. Those in orange on this slide, represented by dose, are those getting placebo, and those in blue are those represented by dose that received 2713, or our 13 program.
This was a safety study, so it was only 12 days long, and there were 50 participants in this study. But you can see corresponding with dose that patients had a profound impact on their weight. This got us very excited, probably not so for AstraZeneca, 'cause they were developing an anti-pain drug with this asset, and they didn't want people having the reverse of Ozempic every time they wanted to take a medicine for pain. But for us, recognizing the unmet need in cancer anorexia, we became very excited about this as a mechanism that could be leveraged.
Now, in all drugs, it is concerning that we might pay a price for the efficacy that we see with adverse events, and there were adverse events in this multiple ascending dose study that I shared with you, that corresponded with severity and frequency as you increased the dose. But I'm happy to report that in the cancer patients, with our new oral formulation and an older population, we have not seen any Grade three or four toxicities. We have not seen any reason to discontinue the drug. We have not seen any reason for dose delays, or adverse events for which you needed to use pharmacological intervention, except for one person who had some diarrhea, that took some Imodium and continued on with therapy. Now, I can't tell you that the drug caused that diarrhea. Maybe it did, maybe it didn't.
It's reported that it could be caused by the drug, but that's one patient out of 24 that were experiencing the drug in the phase 1 study. Also in the phase 2, I'm happy to tell you that we've seen this trend continue, and we're dosing up to 1,300 micrograms on a daily basis. So what does our trial look like? Well, I told you about the phase 1. It was four doses at six patients per dose level, and we established that 650 micrograms was a safe starting dose for the randomized phase 2. Now, in month one, those randomized to receive active drug will get 650 micrograms, progressing to 1,000, and then 1,300 in the last month of the study.
There are twelve weeks of treatment, so four weeks on each dose level, and we're evaluating lean body mass, weight gain, anorexia or appetite, safety, quality of life, and activity as measured by a watch that is a wearable device, FDA-authorized device, that record the activity of people, knowing that if they have more muscle or if they have strength, they'll get up off the couch or out of bed and participate in activities. So we're very excited about what the CARES trial, the Cancer Appetite Recovery Study, may mean for drug development in this space and for the patients that desperately need it. The second program that I would like to share with you is the 12 program. This is the one that I just mentioned.
The FDA notified us that we may proceed with the phase 1 single ascending dose study. But before I talk about that particular program, it's really the first of many out of our fatty acid-binding protein inhibitor platform. So let's talk about fatty acids just for a minute. You're probably aware of omega-3 fatty acids. We get fatty acids from the food we eat: fruits, nuts, vegetables, animal protein. A lot of people think of fish products with fatty acids, but fatty acids are what cells use for energy, and they're what cells use to talk to each other or even within the cell. But fatty acids go into the cell, and they don't know how to migrate the cell without some chaperone.
You can think of a letter that you would draft, but it doesn't know how to get through the postal system unless you put it in an envelope and carry it through the postal service. And in the same way, the fatty acid-binding protein is that envelope that grabs the fatty acid or the letter and moves it around. And so you can see, because you have cells throughout your body from head to toe, you can have a misalignment or a challenge with what this fatty acid signaling is. For example, in cancer, you can have 20 times that of normal of these envelopes. That's because cancer is trying to rapidly feed itself, and so it's consuming a lot of these fatty acids. And so, that's in breast cancer.
You could inhibit these envelopes or inhibit the fatty acid-binding protein and try and retard or slow down the growth of cancer. We have evidence to show that our drug has the potential to do that. Whether it's anxiety disorders or cancer or dermatologic conditions, in psoriasis, which we have data in, or atopic dermatitis, which we're currently doing a preclinical study in, or pain and inflammation, where it's osteoarthritis, where we're doing some work, cancer bone pain, which we just put some data out in the beginning of June, chemotherapy-induced peripheral neuropathy, which I'll share more about with you today, or even diabetic neuropathy caused by a disease rather than chemotherapy, very painful conditions for which new therapies are needed. Let's talk about the 12 program. Its target indication is chemotherapy-induced peripheral neuropathy.
This affects about 40% of all cancer, treated cancer patients, and it's that tremendous pain in the feet and hands or extremities that cause people to say, "I would rather have my cancer than this pain." Believe it or not, that's what happens. Or they come in crying to their physician, "You've got to take me off this medication and put me on something else because I just... the pain is so unbearable." They can't even open the refrigerator door to get a carton of milk without them feeling intense pain. And so if that's the case, and you have to go to plan B or plan C for your cancer, that's not good news.
We have some very interesting data to suggest that the fatty acid-binding protein 5 inhibitor in our hands may be a very efficacious treatment to treat pain and inflammation. Now, why are we excited about this program? Well, it has an outstanding safety profile, and it was the first selective FABP5 inhibitor that has been FDA-cleared for human studies. That safety profile is very exciting. I would like to... And the molecule is represented on the slide in front of you. But I'd just like to direct you to one bullet at the very bottom of this page. That is the no observed adverse effect level, or the NOAEL, of a thousand milligrams per kilogram per day in two species, rats and dogs, over two weeks or 14 days.
This is standard drug development work, and I want you to keep that number of a thousand in mind as I share with you this data. This is data in oxaliplatin, which is a common drug that's used, let's say, in colorectal cancer, where rats are put on a cold plate. You've ever put ice cube on your tongue, you know what I'm talking about, that cold sensation. And you can see that if you're given our drug at only 25 milligrams per kilogram twice daily, that we were able to prevent the cold plate pain that was occurring in the rats. And what's important to understand then, if you're a betting person or you're looking at probability of technical success, what is the likelihood that we're gonna find a safe dose?
Probably a safe and efficacious dose. Probably pretty high if you have a thousand milligrams per kilogram in two species, which you have not found any toxicity on, no observed adverse effect level, and you're getting efficacy at 25 milligrams per kilogram, and it's preventing this from even occurring in the first place. So we're very, very excited about what this data may show us, and we can safely say we're already capturing the attention of global pharmaceutical companies who are either under an NDA or are examining our data in a public sphere. So watch that space. It's exciting for us. Last but not least is our 11 program. This is our own in-house invention of the CBD-TMP co-crystal. Now, the target indication for this is anxiety and depression, and I'm gonna show you some data on that as to why we're excited about it.
But let's just talk about the problem. You know, in my 38-year history, yes, I had some successes of some really interesting drugs like Rituxan, which is a drug for non-Hodgkin's lymphoma and other indications, sells about $9 billion annually. But one of my early drugs that I introduced was a drug called Xanax. I was working for a company called the Upjohn Company that was eventually acquired by Pfizer, and the drug Xanax was to treat anxiety and depression. Here we are, 30 years later, we don't treat anxiety and depression much better than we did 30 years ago, I'm sorry to say. And this is a common ailment that affects a significant number of people in the global population. Many, maybe even observing this presentation, know of a family member because it's so common.
We need new drugs to treat anxiety and depression, and treating both of those is very difficult. What we're excited about, our proprietary CBD-TMP co-crystal. It's a combination drug. We believe a combination drug candidate that's got really interesting characteristics, a very attractive pharmaceutically attractive profile. It's also known as a very druggable profile. So, what is a CBD-TMP co-crystal? Well, you start with a drug, CBD, and then you combine this with a co-former. It forms a co-crystal, which is why it's called a co-former, and you create a new crystalline lattice. If you think of TMP as being water-loving, you're able to bring a water in between these fatty substances like the CBD or lipid substances like the CBD, and create water flowing in, which naturally then creates better absorption profile.
But it's got really four properties that I think are what make it pharmaceutically attractive. One, its physical properties. It has a higher melting point, so as we're in the process, which we're doing right now, we have three formulations, we're trying to figure out which of those is the best to go into patients early next year, so when you think about the heat and the compression that you do, this allows for CBD then to get into a tablet form. It's got better solubility, better dissolution, better bioavailability, better absorption. The pharmacokinetics, with both CBD and its major metabolite, are improved over CBD alone. It has less impact of the food effect. You don't wanna have to take a cheeseburger every time you take a drug like CBD.
We have a patent estate on both, composition of matter, meaning we own this combination, plus we own the methods of use for it, through the end of 2038, which is a tremendous, nice runway for potential market exclusivity. What's most exciting to me is to share with you next. This was data from a stress-induced model of anxiety and depression conducted by Dr. Steven Laviolette up in the Toronto area of Canada, one of Canada's premier neuroscientists, in his lab. We compared our CBD-TMP co-crystal to CBD alone, and in every case, we were efficacious at one-third the amount of CBD than in the CBD arm, and CBD did not ante up. In fact, it was deleterious in one, on cognition. So we really think we have something, special. This has been repeated in another study.
The data came out exactly the same. All of this data is available on our website. You can view it there. Now, I'm representing more than just myself and my background. Obviously, I'm representing a team. But all of our team has their bios on our website, and so I would invite you to look at the team that knows what finished and good looks like and has the resolve to do that here at Artelo. Company capitalization is we have about 3.2 million shares outstanding.
Fully diluted, it's close to four million, with about $5.6 million that's underrepresented, because if you read the postscript, we, 10 days after we reported this, the quarter was closed, we received a check in the sum of $1.3 million from the U.K. government in R&D tax credits, which we enjoy from conducting our trials in the U.K. and elsewhere. And so, that really represents about $7 million at the beginning of July. Someday we're going to need to put cash into Artelo. That's no question about it, but that day is not today. So we're inviting you to come in and participate, and then anticipating what we have coming up in our milestones.
We do have analyst coverage from Vernon, thank you very much, at H.C. Wainwright, and with other banks as well. And finally, in summary, the Artelo opportunity. I hope I've made the case that we have a really exciting pipeline, that it's not just one spin at the roulette wheel. And not to say this is a gamble, but it has a lot of opportunity and milestones coming up in the near term. Billion-dollar market opportunities across our portfolio. I won't belabor that today. A robust patent estate across our entire portfolio, nearly 40 patents issued and another 40 in queue, and the team that I'm representing today. And with that, I'd like to close, and thank you very much for listening to the story of Artelo Biosciences. Vernon, back to you.
That was great, Greg. Thank you for helping us to learn about Artelo Biosciences. Your presentation on opportunities and medical needs Artelo's drugs target was very insightful. We look forward to progress with the CARES phase 1-2 study with ART-2713, as well as updates on ART-2612 and ART-1211 in the coming months. To everyone attending online, thank you. We appreciate your time and hope you are gaining valuable insights and ideas into investment opportunities that we believe are represented by Artelo, and the 500-plus companies participating at our conference this year. Have a good day, everyone.