Niagen Bioscience, Inc. Common Stock 0 Earnings Call

Chief Financial Officer, and Andrew Shao, SVP of Global Regulatory and Scientific Affairs. We have a lot to cover on today's call, but I'd like to start by reminding everyone that statements made today may be considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable securities laws. Actual results may differ materially from those expressed or implied due to risks and uncertainties described in the company's filings with the SEC, including its periodic reports and investor materials. Niagen Bioscience undertakes no obligation to update forward-looking statements except as required by law. As a quick reminder, Niagen, which is trading under the ticker symbol NAGE, is a global bioscience company advancing NAD science through its Niagen platform with a large intellectual property portfolio.

Niagen powers Tru Niagen, its leading oral supplement brand, and Niagen+, its pharmaceutical-grade intravenous and injectable brand, with Niagen IV available in over 1,200 clinics across the U.S. Company recently announced the launch of a drug development program leading with NB4168, the first drug candidate from its wholly owned subsidiary, NAD Pharmaceuticals Corp. We'll focus much of today's discussion on this program, which marks a strategic expansion of the company's NAD+ platform from cellular health products into regulated pharmaceutical development, targeting accelerated aging and rare genetic diseases. NB4168, a patent-protected, more bioavailable NR derivative, is backed by two independent clinical studies and new non-clinical data, positioning it to address a rare pediatric disease with no FDA-approved therapies. Niagen today uploaded a new investor presentation outlining the strategy in detail, which can be found under the presentation section of the investor relations section of our website.

At the end of our Fireside chat today, we'll open the floor to live Q&A. For investors that have not submitted questions yet, please send them through the Q&A function at any time. We'll do our best to get to each question today. If for some reason we can't get to your question today, please email us always at niagen@kcsa.com. Please note this call is being recorded today, Wednesday, July 15th at 11:00 A.M. Eastern. A replay will be available on Niagen's investor relations website following the conclusion of today's discussion. Rob, Ozan, Andrew, on behalf of myself and everyone listening in today, really appreciate your time. Thank you for joining us today.

I'd like to start off today's call with several incoming questions that we already received from investors. I think first, Rob, it may be good for those that may be new to this story to hear who is Niagen, and if you could tell us more about the company and your vision.

Thank you, Valter, and thank you everyone for joining us today. Thank you, Ozan. Thank you, Andrew. NAD stands for nicotinamide adenine dinucleotide. It's a coenzyme found in all living cells, plant and animal, and is vital to most important metabolic processes, but notably energy metabolism. Mitochondria require NAD in order to take the nutrients from food and the oxygen from air and convert it into energy, which is transferred through the cell through ATP molecules. When there's high levels of NAD, you have increased mitochondrial biogenesis, meaning you have more mitochondria and you have a higher yield per mitochondria. Essentially, you have more energy when you elevate your NAD levels. Also, it's responsible for the repair of cell damage. Could be physical damage, could be the presence of a virus, could be oxidative stress, could be inflammation, could be a gene mutation.

The cell has mechanisms in place for identifying and then correcting that damage, and all of those processes are NAD-dependent. As a result, when you have elevated NAD levels, you have a stronger, more resilient cell, some better equipped to deal with physiological stressors. Aging is defined by the World Health Organization as the accumulation of damage at the molecular or cellular level. When you have an increased capacity for correcting damage and an increased ability to create energy, mitochondrial function, that ladders up to the conditions that we talk about as aging. Niagen Bioscience is the company behind all of the amazing amount of research and attention the NAD space has received.

The reason why we position it as an anti-aging company is simply for that very specific reason, that when you have elevated NAD levels, you have increased energy and an increased capacity to deal with molecular or cellular damage. There are many conditions and diseases that are very specific, that may be age-related, that elevating NAD with one of our molecules might actually have a therapeutic value, not just prophylactic preventative, but actual therapeutic value in treating that disease. Indeed, there are certain orphan diseases, there are quite a few of them, that are associated with advanced aging. Children age so rapidly, in some cases, they actually die of old age in their teens. In many cases, these kids have non-detectable levels of NAD. Here's a cohort group that very clearly shows the direct relationship between aging and NAD levels.

We think it is important and responsible for us to investigate these particular orphan diseases, and indeed, we've published many studies, as Andrew perhaps will go through shortly, on many of these age-related orphan diseases that showed a benefit for these kids elevating NAD by taking Niagen. The company, Niagen Bioscience, is not just a consumer products company. A lot of people view us simply as that because we have a product in the market called Tru Niagen, which is one of our key molecules, nicotinamide riboside. Indeed, today, it's probably one of the most successful single-ingredient dietary supplements on the market, certainly in the U.S., probably in the world. We are much more than just a consumer products company. We are a consumer products company with Tru Niagen, and we are soon to be expanding into topical NAD-related products.

We have one on the market already, and we'll soon have more. We are also an ingredients company. We supply ingredients that elevate NAD to a small coterie of other dietary supplement companies, and the dynamics of that ingredient business are quite different than the consumer products business per se. We are also a telehealth company because we have now made available nicotinamide riboside or Niagen via IV or injection to people, either through clinics, which are sold through compound pharmacies, and now we can sell direct to you in your home an at-home injection product, self-administered at-home injection product that you can purchase through our website. Also now a pharmaceutical business targeting these orphan diseases. Those four business segments have slightly different economics. In any given quarter or couple of quarters, the ingredient business is quite volatile.

A customer may place an order, they may not place an order. The core business of NAD and Niagen and Tru Niagen always steadily increases and grows. As NAD awareness increases, the demand for what we provide and what we sell increases. We've shown a steady increase, and we're confident of the future. We think that if we are fortunate enough to show a benefit to one of these orphan diseases, it would be obviously extremely valuable to all of our shareholders and to all these people suffering from these diseases. We've managed to find a balanced sort of de-risked way to pursue these pharmaceutical drugs, while still maintaining profitability and growth and still shooting for these big upside opportunities.

Thank you, Rob. I appreciate that. It's obviously clear that Niagen has built an impressive platform. Much of what you described, branded supplements, ingredients, and now you mentioned telehealth and the topical products. At the onset of this call, I mentioned NB4168. Can you tell our audience a little bit more about that and the drug development program?

We actually have a fairly large portfolio of molecules that elevate NAD levels, one of which we obviously use in our ingredient business. We call it Niagen, and Tru Niagen, our consumer product, but it's not the only one that we've patented and researched and studied. NB4168 is another analog to nicotinamide riboside. Because of the studies that we've already conducted that have been very positive, that Andrew will go through shortly, we have real reason to believe that elevating NAD with nicotinamide riboside has therapeutic value for these kids with these orphan diseases. We believe that NB4168 is even more bio-superior than that. We've identified it, we're pursuing it, and we're very excited about it.

Thank you, Rob. Andrew, maybe turning the call over to you. As Rob mentioned, you all have access to a very large portfolio. From your point of view, why NB4168 as the first drug candidate in your opinion?

Sure. As you mentioned in the outset, it has a superior pharmacokinetic profile. NB4168 was designed to deliver more nicotinamide riboside to blood and tissues. It has a very different pharmacokinetic profile from nicotinamide riboside. Actually, our initial studies on safety show that it has a better safety profile. The other differentiator, of course, is that it is not available in the marketplace as a dietary supplement, unlike nicotinamide riboside, or of course, as a drug, which is why we're pursuing it. There are different reasons why, from a business standpoint, that we would want to pursue something that is not in the dietary supplement market already. Ozan can speak to that. From a scientific standpoint, as Rob mentioned, our initial data suggests it's bio-superior and also has a better safety profile than nicotinamide riboside.

Interesting. Thanks, Andrew. Just to maybe dig in a little bit further, we mentioned targeting accelerated aging and rare genetic diseases. I guess you could provide more detail the applications of this molecule beyond that?

Sure. Great question. Again, Rob alluded to the role of NAD in cell repair, particularly with DNA repair. What you see as a common denominator in several orphan diseases or diseases of accelerated aging is an inability to properly repair DNA or mitochondrial dysfunction, or both. In the case of ataxia-telangiectasia, it's a mutation in the ATM gene, which is a kinase that is needed to repair breaks in double-stranded DNA. The inability to repair that DNA results in neurodegeneration, immune issues. These patients get cancer early on as a result of inability to repair DNA. What we've found from both preclinical and clinical studies using nicotinamide riboside is bolstering the NAD status of these patients helps improve the DNA repair, improve mitochondrial function, and also improve the symptoms.

Thank you, Andrew. Very helpful. Just as a reminder to our audience, we've received several inbound questions. If you have a question, please include it in the Q&A function. This next question, Ozan, good morning, great to see you. Can you walk us through the next steps and timeline required for NB4168?

That sounds great. Just as a reminder to everyone, we have done two investigator-initiated trials on ataxia-telangiectasia using nicotinamide riboside chloride Tru Niagen. Both of those showed really promising results. We're leveraging all of our knowledge from those studies and the decades of experience we have understanding the biology and chemistry of nicotinamide riboside as we work through this drug development program. Over the past year, we worked with regulatory consultants and have done extensive research and had many discussions with KOLs about this specific program using NB4168. As a result of this work that we've done, we now have a plan to move forward with NB4168. This molecule is currently in preclinical stage. This year, as a result of that gap analysis that we've done and the conversations we've had, we're focused on conducting efficacy studies of NB4168 in worm, mouse, and organoid models of AT.

For these studies, we're leveraging our network of researchers through our external research program. In addition to these studies, we're also starting IND-enabling work, such as rodent PK/PD studies, genotoxicity studies, and drug-drug interaction studies. Looking ahead to our clinical plans, safety of NR is very well-established, so we feel comfortable eventually designing our program to have a phase I/II with patients enrolled, then do the single pivotal trial. This is still in its planning stages, so it's not final yet. If we follow this path, and do a phase I/II on patients, that will require us to do additional IND-enabling work, such as a six-month and nine-month tox studies on rodents and non-rodents. These two will take place next year. I also want to flag that our intention is to eventually partner, license, or spin out this program.

Even though we expect the full cost of the program to be manageable, we still would like to leverage expertise of other industry partners.

Thanks, Ozan, I appreciate that. Coincidentally, that was one of our questions about partnering or what the plan is for the future. Appreciate that. Rob, maybe back to you before we get to our audience questions. You have Andrew and Ozan who have incredible backgrounds, but want to talk about the rest of your team. Can you give us an idea about the scientific team and their expertise in this space?

Most of the people that know Niagen Bioscience know that the team that we've assembled internally as employees, advisors, scientific advisory board, and researchers with whom we work are among the best, certainly the best NAD researchers in the world, and probably amongst the best general scientific researchers as well. Vilhelm Bohr, who recently left the National Institute on Aging, is helping us spearhead these initiatives on these orphan diseases. He's done a lot of extensive work on ataxia-telangiectasia with us, but also Cockayne syndrome and Werner syndrome, even Friedreich's ataxia, and now mitochondrial myopathy. These are all areas of high opportunity for us. Of course, Dr. Charles Brenner, who's our lead scientific advisor and the inventor of nicotinamide riboside. We will be announcing a couple of additional additions to our team, scientific additions to the team.

World-class people in the study of anti-aging research, as well as orphan diseases in general. We've already lined up various researchers from some of the greatest research institutions in the world to develop these studies that Ozan just described.

Thanks, Rob. I appreciate that. Again, thank you to our audience for your questions. We've received several questions already. As a reminder, you can submit your questions via the Q&A function. Our first question from our audience, Ozan, maybe you're the best to answer this. The company recently filed a prospectus for an ATM. What are the company's plans for the ATM going forward?

We see the ATM and the S-3 filing that came alongside it as a housekeeping item. We have no reason or need to raise any capital. It's just for us to be mindful. That's it. Great. Rob, just a bit about capital allocation.

What are the priorities for management and the board over the next 12 months?

Well, for those that have followed Niagen Bio over the years, you know that we're very focused on cash management. We have no debt, we have plenty of cash, and we're very focused on being a profitable business. We've been profitable every quarter for several years in a row. We expect to continue to be conservative and fiscally responsible in our approach. We know that there are other companies that sell dietary supplements that look only towards top-line growth and buying influencers and spending a lot on marketing, and they could show top-line growth there, but they don't show profitability. However, as we've said in previous quarters, it is likely that we will increase our marketing spend towards an awareness campaign and a brand campaign with the addition of some influencers and celebrities to help drive awareness.

We will continue to be very fiscally responsible and focus on our balance sheet and focus on our profitability. We may, from time to time, increase our investment in marketing. It's a balancing act between top line and bottom line.

That makes sense. Thanks, Rob. Just a few questions from our audience that I think are interesting. Maybe, Andrew, this is a question for you, and it may be too early to tell. At some point, based on the data that you're going to gather, could NB4168 also become a supplement product?

Well, actually, if we move forward with drug development and eventually receive an investigational new drug, that will preclude it from being used as a dietary supplement. That's a provision in the existing law that protects the investment of drug companies, drug development, to prevent supplements from coming to the market, the same molecule coming to the market as a supplement after it's been authorized for investigation as a new drug.

Understood. That makes sense. Just one final point, and Rob alluded to it, and maybe, Andrew, you want to add a little bit more, just the safety profile that you all have seen thus far on NB4168.

Well, what I could say at this point is at comparable molar equivalent doses between 4168 and nicotinamide riboside, NB4168 is safer.

Great. Thank you. It looks as though we don't have any further questions from our audience. This does conclude today's Fireside chat. I really want to thank Ozan, Rob, and Andrew for their time today. Really appreciate it. As a reminder to our audience, we will be reporting our quarterly results here shortly. As always, we will have a conference call to discuss those results. Thank you so much for your time. If you have any further questions, please email us at niagen@kcsa.com. Thank you everyone. Until next time. Thank you. Thank you, Valter.

Thank you. Thank you, Valter.