Niagen Bioscience, Inc. (NAGE) Earnings Call Transcript & Summary
July 20, 2022
Earnings Call Speaker Segments
Tara Sobierajski
attendeeGood morning, and welcome to the ChromaDex KOL Webinar. [Operator Instructions] This call is being recorded and a replay will be made available on the ChromaDex website following the conclusion of the event. I'd now like to turn the call over to your host, Robert Fried, Chief Executive Officer of ChromaDex. Please go ahead, Robert.
Robert Fried
executiveThank you so much. Good morning, everyone, and thank you for joining us on today's KOL webinar on the transformational benefits of nicotinamide riboside, also referred to as NR or Niagen for short. For those of you whom I've not had the pleasure of meeting, it's nice to meet you. My name is Rob Fried, and I'm the CEO of ChromaDex. ChromaDex is the leading bioscience company dedicated to healthy aging and research on the many benefits of nicotinamide riboside, which is by far the most efficient precursor to nicotinamide adenine dinucleotide or NAD. NAD is the mission-critical coenzyme to cellular metabolism and declines naturally as we age. ChromaDex is Tru Niagen's product, and it is the most efficient way to safely elevate NAD levels. We've commercialized Tru Niagen into a $70 million consumer brand over the last few years that we sell through multiple channels globally. We call it NR for short but also sell as the commercial name Niagen, as I mentioned. Today, Niagen is the only form of NR with regulatory acceptance. We would not be here today without the pioneering work of my friend, today's KOL, Dr. Charles Brenner. Dr. Brenner is the world's leading expert on NAD and a pioneer in several fields, including healthy aging. While at Dartmouth, he discovered the vitamin activity of NR and how it functions as a precursor to NAD. His groundbreaking work on NR was ultimately licensed and developed into ChromaDex's Tru Niagen consumer product. He currently serves as the Alfred E Mann Family Foundation Chair in Diabetes and Cancer Metabolism at City of Hope National Medical Center. He's also ChromaDex's Chief Scientific Advisor. You could read more about his work in the press release for today's event. Following Dr. Brenner's formal presentation, ChromaDex's Senior Vice President of Global Regulatory and Scientific Affairs, will moderate Q&A session. Please take it away, Charlie.
Charles Brenner
executiveThank you, Rob. It's a pleasure to present the science behind Tru Niagen this morning. So you can see more about my lab at brennerlab.net. As Rob said, I'm on the faculty at Beckman Research Institute at City of Hope. It was my laboratory that discovered the vitamin activity of nicotinamide riboside, the NR kinase pathway. And not only do we investigate NAD metabolism, we also develop a lot of technology related to NAD. One of the things that I'll show you today in the course of explaining what NAD is and what the use cases of NR are is I'll show you about quantitative targeted NAD metabolomics. And what that basically indicates is all the conditions that disturb the NAD system, and those really define the use cases for NR. So my disclosures, as Rob said, I developed the intellectual property on uses of nicotinamide riboside that were developed by ChromaDex and serve as ChromaDex's Chief Scientific Advisor. I'm also a co-founder of a company called Athena Therapeutics in the cancer metabolism space. This is a view outside of our lab window looking north to the San Gabriel Mountains in California. So in short, I'm here because ChromaDex is the NAD company, and I'm the NAD guy. And my goals this morning are fivefold. The first is to explain what is NAD, what is NR; second, to explain what are the use cases for NR. Once we all get on the NR train, why Niagen NR? We will address NMN, and we'll also describe the clinical landscape of NR today and going forward. So to explain what NAD is, I'm going to first show you an electric car, right? So this is not such a rare thing any longer. You have an electric vehicle or you know someone who has an electric vehicle. And this electric vehicle basically cannot move without electrons. And so it's got a huge battery pack usually under all of the seats. And then it has units that need power such as the transmission that's driving the front, rear or both axles, and a cooling system. And there's wiring. There is literal metal wiring that carries electrons to these mechanical units in order to power the vehicle, in order to power the motion of the electric vehicle. Well, it may surprise you that electrons are also required to power all life as we know it. And the high-energy electrons are principally carried inside of cells by 4 NAD coenzymes. So without the energy that initially comes into our body from food and the high-energy electrons that are extracted on to NAD coenzymes, we wouldn't be able to have an idea, we wouldn't be able to develop, we wouldn't be able to move, we wouldn't be able to repair ourselves, we wouldn't exist. This is da Vinci's Vitruvian Man but I could show you any living creature and all of the motion and all of the vitality, the literal vitality of living things depends upon 4 NAD coenzymes. So these coenzymes are the central catalysts of metabolism and repair. They come in sort of 4 flavors. You know there's half a dozen quarks. There's 4 NAD coenzymes. The one on the left is called NAD+. The one on the right is NADH. And in going from the left form NAD+ to the right form NADH, that's where high-energy electrons are harvested in burning food, in burning our fuels of protein, fat and carbohydrate. We generate that NADH. Then the NADH is converted back to NAD+ in making ATP, in making biological energy. That's really how fundamental NAD is to our body, is a conversion of food into energy. But NADH is also converted back to NAD+ to maintain our blood glucose to generate ketone bodies. There's 2 other NAD coenzymes. They're called NADP and NADPH that are depicted here. They basically have phosphate that was on something called a 2 oxygen. And NADP is converted to NADPH in making nucleic acids, making RNA and DNA precursors. And then the final NAD coenzyme, NADPH, is required to detoxify free radical species to generate estrogen and androgens, lipids and steroid hormones that, again, power our body and allow us to repair and make everything in our body. So these are the central catalysts of metabolism and repair. Now NAD is made inside of all of our cells, 40 trillion cells, and there are 4 different gene encoded pathways to make NAD from 4, what we call, precursors, so molecules that are converted inside of cells to make NAD. And those 4 precursors are tryptophan, niacin, nicotinamide and NR. So what are the differences between these 4 things? Are they equivalent? Really, they're not equivalent. So tryptophan can make NAD in some cells, not in all cells and tissues, and very inefficiently, why? Because tryptophan is also used to make protein. It's used to make serotonin. It's used for dozens of different things. So niacin, classical B3 vitamin, can be converted into NAD coenzymes in some cells, but when it's used at higher levels, hundreds of milligrams we're talking, it produces a side effect of flushing. So red and heat at one's extremities. Nicotinamide is converted into NAD in virtually all cells that we know of. But the nicotinamide gene pathway is actually turned down in many of the conditions of metabolic stress and aging in which we most need NAD, the nicotinamide genes are turned off. And I'll show you what that looks like in a minute. And not at graduate or PhD level, I'll show you in very simple terms how the nicotinamide pathway gets turned off. And in those same data, you'll see that the NR pathway gets turned up. So we have genes and enzymes that will turn on the NR pathway when cells and tissues are in trouble. When NAD is under attack, the NR pathway gets activated, and that's why Rob explained to you that this is really a vital NAD precursor with unique properties and unique efficiency in repleting or filling up our NAD storage or NAD batteries and the NAD wiring that is required to run our bodies. So this is an example, and really one of the most striking examples of NAD coming under attack. Well, in people, cardiovascular diseases, including heart failure, are always in the top 2 causes of death. And we don't know who's going to suffer from cardiovascular diseases at the outset. But in mice, we kind of do. So in mice, we have genetic models that are predisposed of 100% of the mice are going to have cardiovascular problems and heart failure. And this is a mouse model in which all of the mice are going to get heart failure in 2 months' time. But at 25 days and 45 days, they still have a pretty normal heart and a gene called nicotinamide riboside kinase 2, NMR K2, that my group discovered is the most highly induced gene. So this is the NR kinase pathway. The NR utilization gene is spiking up to be the most highly expressed gene in this disease model. NAMPT, which is a gene that is required for nicotinamide usage is going down. Well, you can maybe try to dismiss this and say, okay, Brenner, this is just a mouse model. But it turns out in human heart failure, the same thing happens. NMRK is at a low level but in heart failure, it's at a high level. NAMPT is at a high level, but in heart failure, it's a low level. Human heart failure, that NR pathway to NAMPT pathway goes up just as it does in a mouse. And NAD is under attack. NAD declines in this mouse system. And NR can get that NAD level back up in the failing heart such that the mice that have this disease model that are given NR are basically protected against the development of dilated myopathy and heart failure. So you can see the ejection fraction is terrible. The fraction shortening is terrible without NR but with NR, the ejection fraction and the fraction shortening and 6 other parameters we don't have time to go into, all get repaired with NR. So NAD is under attack. The NR -- the cell is trying -- and the tissues are trying to protect themselves. It's called homeostasis. They're protecting themselves by turning up the expression of the genes that we discovered that convert NR into NAD. So NR is highly protective in these mouse models of heart failure. And so this, basically, was a stimulus for us to use this technology that we developed a quantitative, targeted NAD metabolomics to characterize all the conditions that challenge the NAD system. And it turns out -- and some of these things were known in the olden days and some of these we discovered but it turns out that alcohol and overeating and noise and sun and oxygen damage, changing time zones, all disturb the NAD system. I'm sometimes in lay groups, and I ask for a show of hands of how many people would love to hop on a jet, fly to Ibiza, sit out in the sun, listening to loud music, drinking wine and eating lots of food into the night, and everybody raises their hand. And all of those things, to excess, have been shown to disturb the NAD system. And in many cases, we have data like in human alcoholics and in human data that show the NAD system is under attack in all of these normal conditions of life: sun and oxygen, sound, changing time zones. But in addition, we've shown that infection and inflammation, coronavirus infection, actually anything that disturbs what's called the innate immune system, which is the body's first defense against bacteria and viruses, will activate the NAD system and deploy NAD in order to fight infection, inflammatory processes that are trying to fight infection, disturb the NAD system, as I already showed you, heart failure, but also central as well as peripheral neurodegeneration. We've shown that new mother mice and rats have a disturbed NAD system, and this has prompted a lot of clinical trial activity for new moms, new human moms that would be supporting their lactation system and potentially their child development by supplementing with NR. And then we know that the aging, all of these happen during our lifetime such that with time, our NAD systems come under attack in multiple cells and tissues. So these are the use cases. These challenges of the NAD system and observations that the nicotinamide riboside gene pathway gets upregulated when NAD comes under attack. These define the use cases for NR, right? So sun, oxygen, virus exposure. These turned out, we learned very well in the last 2, 2.5 years, that exposure to viruses and infectious agents is inevitable. And we already knew that exposure to sunlight and oxygen is part of life. And in addition, of course, there are many, many disease processes that challenge the NAD system, including central neurodegeneration that may turn out to be the biggest story of 21st century science, obesity and neurodegeneration. But early adopters, of course, of Niagen have included people that are very conscious of their own performance, right? So athletes, actors, executives, people that know their body and know what they can expect from themselves, expect a lot from themselves and have sort of observational data that their mental and physical recovery is better on Niagen, that their performance is enhanced by Niagen. And so the idea here is that NR protects against intrinsic cellular damage that occurs as we age and go through life as well as extrinsic cellular damage that is exacerbated by things like virus and sunburn and overconsumption of alcohol and food. There's a great deal of clinical testing. There's early indications of positive signals for blood pressure regulation, fatty liver, kidney injury, body composition in women, lactation, there's clinical trial activity. And then there's some new positive results in small trials on cerebral blood flow, in Parkinson's. There is a Phase II and III positive result for COVID recovery in combination with 3 other over-the-counter agents. There's multiple placebo-controlled reports showing reduction of inflammatory markers with Niagen as a solo agent, and there's clinical trial activity involved in heart failure, protection against heart failure. So why Niagen? So I've given you a use case for NR generically. So why Niagen? Well, there's really an unparalleled safety dossier for Niagen. Niagen is a specific preparation of NR. There's a specific synthesis. There's a specific crystallization with specific manufacturing processes that put something in a blue bottle that has regulatory acceptances in the United States, Canada, the European Union and Australia. The same cannot be said for other sources of NR. There are used manufacturing crystal form patents. There is a great deal of know-how behind our team. The pipeline is boosted in part by over 250 material transfer agreements with investigators at universities, research institutes and hospitals around the world that are getting their own funding to test this molecule in all of their favorite disease and conditions of metabolic stress and age. And there are 20 published peer review clinical trials, the vast majority of which are with Niagen from ChromaDex and 37 more that have been registered. So NMN, we should absolutely talk about NMN. So really, NMN doesn't make any sense. So what is it? It's NR with a phosphate attached to it, right? And so we've done research on it. And whether you put it into an animal or human or even a cell system, the first thing that happens to it is the NMN gets converted into NR, right? And then if you look at whether it will elevate NAD, NMN and NR both depend upon nicotinamide riboside kinase. So this is genetic proof that NMN doesn't have a unique way of getting in, that there's no end around the NR kinase pathway. Basically, a chemist is going to the trouble to put a phosphate on to NR, right, and then someone is ingesting it and then that phosphate is coming off, and then it's acting as NR. And these data are absolutely incontrovertible. There's basically -- there's little safety data. There's no regulatory recognition anywhere. And moreover, there's a company that is creating investigational new drug filings for NMN, and once you have -- going through the process of trying to make a drug and getting investigational new drug status for something, it can never be a supplement. You can go from a supplement to being a drug but you can't go from a drug and also be a supplement. So we acknowledge a broad disinformation campaign about NMN. It is a challenge for us to continue to educate people about NMN but it simply doesn't make any sense. Very few people know what's in the bottle. And even if they knew what was in the bottle and it were shown to be safe, it doesn't make any chemical or biochemical or physiological sense. So human clinical trials, and I'll just sum up here and then we can take Q&A. There are multiple -- I mean, safety first with this company. And so there are multiple completed human safety trials that are placebo-controlled up to 2 grams a day for 12 weeks. There's indications from one of the very first trials that Niagen lowers blood pressure in people with moderately elevated blood pressure. It may lower fatty liver in men and improve body composition in women, that came out of placebo-controlled trials. Clearly depresses inflammatory markers in elderly men, that's been repeated and seen in other trials. It improves cerebral blood flow in a small Parkinson's trial. It accelerates time to recovery in COVID-19 when combined with 3 other molecules. Like I said, about 50 registered randomized controlled trials worldwide. And I'm personally interested in protection against diabetic as well as chemotherapeutic neuropathy. I'm interested in supporting maternal health and lactation. And I'm super interested in fatty liver as well. And so I think we're going to kick it back to the inimitable Tara, and she's going to take your questions and answers. Thank you.
Tara Sobierajski
attendeeGreat. Thank you, Dr. Brenner. [Operator Instructions] So our first question comes from Ram Selvaraju from H.C. Wainwright.
Raghuram Selvaraju
analystCan you hear me?
Tara Sobierajski
attendeeYes.
Raghuram Selvaraju
analystSo just a couple of things. I think, Dr. Brenner, you touched on a lot of different elements, which clearly demonstrate the pleiotropic nature of this molecule and the various pathways that it influences. But I'm particularly interested in your views on 2 elements because of their topical nature and the large market opportunities that they represent. Historically, ChromaDex had looked at the activity profile of another molecule, pterostilbene, in hypertension. I was looking to see if you could clarify for us what specific indications within the cardiac space you believe are most likely to be amenable to addressing to amelioration through the judicious application of NR. And then also if you and maybe perhaps Rob as well could opine on what the future may hold for the application of NR in the context of COVID-19. Because clearly, the market continues to evolve, but it also appears clear that the pandemic is not going away. But what might be the plans for future assessment of NR in the context of improving patients' recovery from COVID-19, given where we currently stand?
Charles Brenner
executiveCan I take it in reverse order, COVID and then cardioprotection?
Raghuram Selvaraju
analystSure.
Charles Brenner
executiveWell, my initial idea based upon the data that we had in our first coronavirus publication is that Niagen was going to protect against infection. And the paper turns out to be very widely read and picked up by people, pulmonologists and infection disease docs, that were working in a hospital in Sweden and had patients that they wanted to treat, and there's no drugs, right? And so the first completed trials were scoring time to recovery, which I'm very pleased to see positive results there. But my idea was to actually look at protection of health care workers and housemates of people that were infected to see whether you could get a signal for protection against infection. And this is a trial that's not really been done yet. And I agree with you that we've kind of come into a phase of endemicism, right, in which there's -- continues to be community transmission and community exposure, and we don't know what percent of the people in a Trader Joe's are walking around with an infection, right? And so I think that more trials need to be done, and it would be terrific to be able to make a claim that was based upon Niagen alone as a potential protective factor such that all people could be encouraged to use it. Similarly, in the cardiac space, our -- this -- when -- back at Dartmouth, we had IP for uses of NR for food supplement as well as drug, right? But ChromaDex has gone over the counter with the product, right? So it doesn't currently have a disease indication involving protection against heart failure or recovery from heart failure, although there is very nice clinical trial activity at University of Washington, Seattle, being tested for precisely those indications. But we think that the data indicate that ongoing use of Niagen could be cardio helpful in a general population sense.
Tara Sobierajski
attendeeThank you, Ram. So our next question comes from Sean McGowan from ROTH.
Sean McGowan
analystCan you hear me okay?
Tara Sobierajski
attendeeYes.
Sean McGowan
analystGreat. Pleasure to meet you via Zoom, Dr. Brenner. I kind of feel like I'm being introduced to a legendary songwriter, who's been behind the scenes with some big hits, and it's finally a pleasure to -- we've been around the company for a long time, and it's a pleasure to make your acquaintance this way. I have one very quick question, and then one that maybe has more discussion around it. First, is there anything bad about the phosphate that's attached to NMN? Is that completely harmless? Like is there anything negative about taking it that way?
Charles Brenner
executiveWe're -- we presented a poster at the NAD biannual meeting in Colorado, and the data are going out for peer review, in which we compared all of the NAD precursors in a model of rat postpartum essentially, right? So we got rats pregnant, they had babies, and then we gave them different types of chow that had either niacin, nicotinic acid, nicotinamide, low or high dose of NR and NMN. My expectation was that NMN and NR would perform identically because the rats would kind of take the phosphate off and the NR would be used. But NMN didn't perform well in that assay. And where the NR mice had great body composition, the NMN mice were gaining fat. And so I don't fully understand it, but we do have some data -- and we were blinded by the way. We didn't have cages that were marked NR, NMN, blah, blah, blah. We were completely blinded. There was a coding where after all of our analysis was done, individuals at the Gates Foundation broke the code, and we looked at how all of the mother rats and their babies did. And NMN did not perform well. So I don't understand why it did not perform well but there's basically, there's no positive use case for NMN, and I don't think there ever will be.
Sean McGowan
analystOkay. And then my second question was, I'm over 60 years old. I've seen doctors all over the country for any number, I think, the conditions that there have been clinical assessments of -- for NR, and nobody's ever mentioned this. So how do we get doctors talking about this? Is there a reason that they won't? And is there a way to get them talking about it? And they'll tell me to take any kind of -- they'll prescribe prescription drug. They'll give me vitamins. They'll give me -- tell me I should take more of this, less of that or something, but no one's ever mentioned NR. So how do we get them talking about it?
Charles Brenner
executiveI guess we're in the second or third inning here. And you said that you consider me like a well-known songwriter. I guess I'm not that well-known, and the story is not well-known. The science is really, really strong. I mean, there are thousands -- tens of thousands of papers in PubMed on NR. So it's a challenge to all of us, I think, to communicate more and better. But I don't think there's any conspiracy against it, and I think that you're going to see greater awareness in the future.
Tara Sobierajski
attendeeThank you for the question, Sean. Our next question comes from Mitch Pinheiro from Sturdivant.
Mitchell Pinheiro
analystSo my question, I guess, for Dr. Brenner, is actually the same exact question Sean just asked or just -- so is there -- what is the gating factor to prevent faster adoption by consumers and health care practitioners? Is there something -- I mean, why -- I mean, I see all of the PubMed articles, and I see the publications in Nature and all sorts of widely read publications. But what is it that doesn't get this on -- it might be on the radar but it's just a blip. Is there some -- I don't want to say distrust but is there something in the science that it's -- there's still a wait-and-see. I would just love to hear you a little -- dive a little bit deeper into what might be holding back a health care practitioner?
Charles Brenner
executiveI mean I'm a PhD scientist, not a health care practitioner and also not a marketer. So I don't know what more I can do. I don't know if other folks on the ChromaDex team have thoughts on adoption.
Mitchell Pinheiro
analystSo it's not really -- so there's nothing in the science that would be preventing faster adoption? It more -- is there -- is NR more challenging than other vitamins and supplements to convey the health benefits because...
Charles Brenner
executiveI think it's kind of a relatively -- as molecules go, it's something that is getting into the public consciousness. I think NAD itself was measured -- was mentioned twice in billions in terms of pop culture references. Someone showed me the other day of a novel they were reading on the beach in which someone was getting an NAD IV injection or something like that. So some of it is a little twisted in terms of what is the best way to protect one's NAD. I think that it's starting to get into the public consciousness. But I mean, the science is an amazing story, and there's not been a lot of cases in the 20th or 21st century in which there were new vitamins that got use cases. But folic acid, certainly for pregnant women, right, to prevent the development of -- the incidence of cleft palate in their developing kids. NR, I think, is going to get a wider adoption as we go forward.
Mitchell Pinheiro
analystI guess just my final question is simply it seems like most of the science, when you look at dosing, uses a lot higher doses than the typical 300-milligram like a Tru Niagen capsule. What is the right -- how do consumers -- how do we -- me as a consumer -- are consumers supposed to think about the right level?
Charles Brenner
executiveYes, it's a good question. So most of the clinical trials that are being registered have investigators looking at 1 to 2 grams per day. And the health care, practitioners which was part one of your question, have access to Tru Niagen Pro at a 500-milligram dose. And they have plenty of their patients or they themselves might be taking a couple of those per day. We don't know what the doses are on NFL teams because they don't like to talk about it. But there's certainly people that are using it at the therapeutically tested doses for which the safety data have been established, as I said earlier, up to 2 grams. But -- so there are people that take 3 300-milligram capsules a day. There are people that take 2 500-milligram capsules per day. And as I said, there -- the most important use case in some sense is how you feel. And if you are trying to run a faster mile or keep your mile time, and you find it useful and you find that you recover from scrapes and bruises really fast and you tend not to get infected, then we really become a Tru Niagen devotee.
Tara Sobierajski
attendeeThanks for the question, Mitch. This concludes the verbal portion of our Q&A session. I'll now turn the call over to Andrew Shao to read the remainder of the questions from the webcast.
Andrew Shao
executiveThank you very much. Thank you, Dr. Brenner, for yet another great presentation. We appreciate so much your expertise and insights. A number of interesting questions coming in from other participants in the event here. So one of, I think, most popular questions that you probably get -- we receive as well given all the interest in NAD, why not just take NAD directly as a supplement? Why rely on precursors? Why not take the molecule directly if it's available?
Charles Brenner
executiveYes. Well, you could probably find NAD or NADH in a bottle, right? And what's going to happen when someone ingests it is it's going to be degraded down to NR, basically. So it's the phosphate problem again. NMN has 1 phosphate, that's 1 phosphate too many. NAD has 2 phosphates, and NADP has 3 phosphates. And in the process of digestion, all of those phosphates come off. NR is the biggest piece of NAD that can go into cells. Cells are ready to convert it back up into NAD inside the cells. But -- and the same thing actually goes for intravenous. When people are taking an intravenous NAD, the NAD is being degraded down to NRs going into cells as NR. So it basically doesn't make biochemical or physiological sense. It doesn't bypass any cellular process. And you don't know that it's safe because it doesn't have a safety dossier behind it.
Andrew Shao
executiveHere's another question, asking about fertility studies. Can you discuss any relevant NR and fertility studies?
Charles Brenner
executiveThere's some data in the context of mice, right, in which from our group and others that older females, have a declining fertility and oocyte quality, NAD, the supplementation in the form of NR seems to protect that as well as delivering healthier pups to moms, whether they're young or old. The clinical data, human clinical data, on that are still on the way. The first things that relate to maternal health that have shown up on clinicaltrials.gov, which is the global repository of clinical trial registrations relates to lactation, where at UC Davis, they're going to be looking at whether NR supports human milk production.
Andrew Shao
executiveThank you, Dr. Brenner. There's also a couple of questions -- I think you spoke about it in your presentation, a couple of questions asking about the Gates Foundation study. If you could maybe go through those results again.
Charles Brenner
executiveYes. Yes, they're basically semipublic because we presented them at the NAD meeting last month. And essentially, NR did really, really well. So it was a fully blinded study where our personnel didn't know what the rats were getting, and in essentially every different category, either NR or nicotinamide outperformed all of the other NAD precursors. NMN was not a standout by any means. Nicotinic acid and tryptophan tended to make the moms sort of not develop well, and NMN kind of made them fat. So the data will be fully observable by anyone in coming weeks and months. But it was a very successful trial for NR, and we were impressed by it because it was fully blinded.
Andrew Shao
executiveThank you, Dr. Brenner. You had alluded to this also in your presentation. There's a question asking about neuropathy and some of the research that's been done on NR and neuropathy. I will add that there are a couple of studies that are registered right now, clinical studies that are registered using Niagen in cancer patients examining its impact on neuropathy, and those are still ongoing, not yet completed. But from your perspective, on neuropathy.
Charles Brenner
executiveIt's a great use case because it's one of the really terrific examples of where NAD is coming under attack in a damaged nerve. So it turns out that NMN accumulates in a damaged nerve due to complex cell biology that we won't go into. NAD is coming under attack, calcium gets mobilized, and the nerve dies back. And so in multiple models, NR is highly protective against neuropathy, and it's protective in mice, it's protective in rats, and we expect to see use cases in humans. There are 2 faculty members at City of Hope that are interested in cancer survivorship issues, and both of them have some plans to look at the potential benefits of NR in cancer survivors. One in a pediatric context, one in adult cancer context. So I'm very excited by that.
Andrew Shao
executiveThank you, Dr. Brenner. Another question here. You had talked about the importance of NR in exercise or recovery. And so there's a question in here, what's that mechanism for how NR may support recovery from exercise?
Charles Brenner
executiveYes. So it may be that it's detoxication, reactive oxygen species and sort of promoting health healthy inflammatory processes. So there are inflammatory markers that actually come up when we exercise, right, because it's a stress to the system. It's overall healthy, but there are things that you can measure that look like the body is a little bit upset. I mean you can feel it in your bones and you feel it in your muscle after you exercise. And so the idea is that there are repair processes that gets stimulated by exercise. There's autophagy and other repair and cellular renewal processes that get activated by exercise, and all of those processes require NAD.
Andrew Shao
executiveExcellent. Thank you, Dr. Brenner. I'm going to pivot for a moment over to our CEO, Rob Fried. Rob, a quick question for you is what is ChromaDex doing with other next-gen of NAD precursors?
Robert Fried
executiveHappy to hear that question. As most of you who have followed ChromaDex are aware, we have put a tremendous amount of time and energy and resources into protecting the intellectual property that ChromaDex has developed. Thanks in part to Charlie's great work and others. We've also invested a great deal in research and development for other precursors, and this is what this question is referencing. There are other molecules that we have studied, studied ourselves or with Dr. Brenner or with other researchers, that are often related to NR or even separate from NR that also have specific benefits. Perhaps, Charlie, you could speak a little bit about that, but I understand that it's been a tremendous investment on the company to establish this intellectual property portfolio and this portfolio of NAD precursors, and we have not yet monetized them.
Charles Brenner
executiveYes. I mean, put it this way. We can't break any new ground here or timeline for introduction, but we have investigated other NAD precursors in our lab and in sponsorship agreements with ChromaDex. And we continue to innovate in the NAD space. We advised ChromaDex. And so we're all smiling with the question but we can't give that detailed response.
Robert Fried
executiveWhat I will say is that we are the leading NAD company in the world, not just our portfolio but our research. I'm sorry. This -- my dog, somebody's delivering something here. But we do expect to have some significant news in the future about other molecules that we are researching. Others have recognized that NAD is extremely important and that it has a positive impact on health. We were the first to commercialize an NAD precursor in nicotinamide riboside. We were the first to establish why it is very important when we started here a few years ago. Even my 2 sisters who are neurologists and physicians and my own internists, were not even quite sure what NAD was. They remember it vaguely from medical school or from graduate school. But now, it is widely understood and known. I personally have many connections and relationships here in the Los Angeles Hollywood community. It is extremely popular for people to get these NAD IV infusions. We think we are at the vortex of that messaging of NAD, and we were first to come out with the best precursor that's in the market, and we believe and plan to have more announcements in the future. We think the best is yet to come in terms of our offerings. When I say we have not yet monetized that research, understand that our plan is to monetize that research.
Andrew Shao
executiveThank you, Rob. Thank you, Dr. Brenner. I'm just going to address a quick question that came in. Dr. Brenner, you referred to a 500-milligram version of Tru Niagen that's available for practitioners called Tru Niagen Pro. That's sold through a separate website that practitioners have access to, signing up, create -- registering, creating a username and the log-in in order to access that product. So it's exclusively for practitioners. Back to you, Dr. Brenner, a question about NR and its possible role in improving inflammatory-related diseases, specifically here, inflammatory bowel disease, IBD. At the moment, there are no ongoing studies that I'm aware of or published studies in human clinical trials yet but perhaps you could comment from your perspective, Dr. Brenner, on NR and IBD.
Charles Brenner
executiveYes. It's a potential use case. There are some indications that NAD comes under attack in some of those diseases. It's always good to have subclassification of a disease. Like for example, in the context of heart failure, one would want -- if one were doing those clinical trials, one would want it to have a patient selection mix that really had the NAD system implicated. But I think that there are such data in inflammatory bowel, and so we strongly encourage the researchers in that community to get in touch with ChromaDex and do such trials. I'm not -- as you said, I'm not aware of one.
Andrew Shao
executiveExcellent. Going back through here. So here we go. What about -- any thoughts on other forms of NR that are on the market, Dr. Brenner? One that's asked about here specifically is NR -- hydrogen maleate, for example. What are your thoughts on these other forms of NR?
Charles Brenner
executiveThere's no safety dossier, to my knowledge, and so I don't know why someone would risk it.
Robert Fried
executiveThere are also -- I just want to add on that particular one, there are more than one patents which they are challenging by producing that. I think they are making a significant strategic mistake by pursuing that. But when you have something great where the market potential is this significant, it is inevitable that you're going to -- here's the problem with this industry and all industries. It's populated with people. And where you have people, you have this opportunism. They're not happy to just be supplied or share the market. People want to steal things or claim things. They want to claim Charlie's science. They were the great innovators that came up with the science, or they're the ones that have the great patent or the great product. And so it's inevitable that you're going to have people try to lean into it and make claims and try to get their piece of it. We understand that, and that's been -- that's sort of human nature. But the reality there is that NR maleate does get around one of the patents, true; doesn't get around several others. There is no research around this NR maleate. Let them promote it. He's making a strategic error. We were supplying it to him. He decided he wanted it all to himself. So they pursued it. I think in the long run, most of the research/scientific, consumer/investor community will realize if you want to invest in what's actual real, real science, real products, safe product that delivers a benefit, you invest in ChromaDex.
Andrew Shao
executiveThank you, Rob. Thank you, Dr. Brenner. A couple of minutes left here. Here's another one. Why use NR when multiple studies show that very little intact NR actually gets absorbed?
Charles Brenner
executiveRight. So genetics doesn't lie, is the answer. So there are -- the data that the question is referring to that indicate that much of NR is dissembled in the liver, and then the liver is distributing nicotinamide to other tissues, and only nicotinamide gets to the heart -- according that theory, only nicotinamide gets to the skeletal muscle, is another aspect of that theory, and that theory cannot be true. So I actually showed during this hour a mouse that has a failing heart in which the NR kinase genes are going up, the nicotinamide utilization genes are going down. The mouse was given oral NR and oral NR -- sorry, oral NR and oral nicotinamide. Nicotinamide is not fixing the problem in the failing heart, and NR is. So that shows that NR is available to the heart, and the same group, one of the same investigators involved in the story that the liver dissembles the NR and distributes the nicotinamide, has a paper in which they've knocked out the NAMPT gene in skeletal muscle and shown that NR cures that mouse. So there's incontrovertible genetic evidence showing that NR is available to tissues that, that research group cannot find by their analytical methods. So we're quite confident that NR is available to skeletal muscle, to heart, to brain and to other tissues on the basis of genetic evidence.
Andrew Shao
executiveAnd then we can add to that the multiple human clinical studies that show that the Niagen dose dependently raises blood and tissue NAD levels in animals and humans as well.
Charles Brenner
executiveAnd we've tracked the carbons and the oxygens, and we've shown incorporation of intact NR into multiple tissues.
Andrew Shao
executiveExcellent. Thank you for that. I think maybe we have time for one more question, if that's okay with our organizers. This may be a tough one to answer but there's a lot of interest in longevity and healthy aging. Is Niagen a longevity pill?
Charles Brenner
executiveI don't think there is a longevity pill that one can make on evident -- with an evidence basis for it because one would have had to do a trial in order to look at longevity as an endpoint. We're comfortable with healthy aging, age better, resist multiple conditions of metabolic stress. But we don't like blowing smokes up nether parts. And so we don't use language that we can't really defend. And so I'm really comfortable saying that this is a health and wellness promoting project -- product, and that we don't get ahead of our skis making claims that can't be backed up.
Robert Fried
executiveAnd I'd like to add to that, Andrew. Since we started the Tru Niagen Company, Charlie and I, many years ago, the messaging has always been very informed by Dr. Brenner's point of view. And he has a very strong science-based conservative point of view, whereas you look around the world and you see people, even scientists, from well-known institutions are willing to just jump out there and say longevity, live longer; and ChromaDex does not, and Dr. Brenner does not. However, if you look at the definition of aging from the World Health Organization, the 9 hallmarks of aging, and you look at what the data is suggesting about what NR does within the cells, we sort of hit 9 out of 9. And we have other indications like these orphan diseases such as Cockayne's disease, where children age so rapidly that they generally die of the symptoms of old age by the time they hit their teens. And these kids are severely NAD deficient. And there's a mouse study from the NIH that shows a benefit from nicotinamide riboside to that disease. So -- but we are very careful to message it conservatively and appropriately and not appeal to people on an overall simplistic basis. That's part of who we are. That's part of how we operate. It makes it a little tougher, but it's core to our values and it's core to our identity.
Andrew Shao
executiveThank you, Rob. Thank you, Dr. Brenner. Well, this concludes our Q&A session. We want to thank our speaker, of course, Dr. Brenner; thank Rob as well for participation; thank everyone for their participation today in the audience. There will be a replay of this event on the investor portion of our website. So we appreciate everyone for joining, and hope you all have a wonderful rest of your day.
Charles Brenner
executiveThanks, all.
Robert Fried
executiveThank you, everybody.
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