OTCQB: GENFF | LSE: GENF
OTC Markets: Hello and welcome to Virtual Investor Conferences. On behalf of OTC Markets and our co-host, Zacks Small-Cap Research, we’re very pleased you have joined us for our next live presentation from Genflow Biosciences. Your session will be moderated by Brad Sorensen, Senior Equity Research Analyst with Zacks Small-Cap Research. Please note, you can submit questions to the presenter in the box to the left of the slides. You can also view the company’s availability for one-on-one meetings through the scheduled meetings tab found on the conference platform. At this point, I’m very pleased to welcome Eric Leire, Founder and Chief Executive Officer of Genflow Biosciences, PLC, which trades on the OTCQB venture market under the symbol GENFF. Now, the LSE is under the symbol GENF. Welcome back, Eric.
Eric Leire: Thank you for giving me the opportunity to share my passion for what I consider the most exciting biotech company on the market. Let’s start. The session today will be a short presentation, as short as possible, five minutes, just an overall presentation of the company, and it should be followed by a discussion with Brad that will be easier for the audience. As Brad mentioned, we are listed on the London Stock Exchange, and we’re trading in the US on OTCQB, so I have to have this forward-looking segment; you are used to it. Let’s move to the real presentation of the company. At Genflow, we are a longevity company. We consider longevity both as a problem and an opportunity. It’s a problem in spite of the fact that in the last hundred years, we have gained a second life, moving from 40 years of life expectancy to 80 years.
EL: We are still losing half of this second life fighting against cancer, diabetes, cardiovascular disease, and neurogenerative disease. When you combine this with an aging population and a higher cost of therapy, you can see this is a problem and an unsustainable situation for society. It’s a problem, but it’s also an opportunity. It’s an opportunity because we have started to understand the biological drivers of aging. As we identify those biological drivers of aging, we can use those to identify new targets to better treat age-related diseases. It’s also an opportunity because when health agencies recognize aging as a risk factor, and this will happen, and when those agencies regulate the development of anti-aging drugs, it’s very likely that we’ll see a big move from big pharma and a major wave of acquisition of the few longevity companies.
EL: We use the understanding of the biology of aging to develop new gene therapy based on those genes that regulate aging. Sirtuin 6 is one of that age-related regulator gene that has been identified in multiple species, both in small animals and in humans. In addition, we use a mutation of the Sirtuin 6 that we found only in centenarians. So in some kind of a super Sirtuin 6, that allows people to go to, pass a hundred years age. Genflow is also supported by a fantastic team, both at the management level, at the board level, and at the scientific advisory board, with a longevity expert such as Vera Gorbunova of the University of Rochester or Eric Verdin at the Buck Institute. We’re not a one-trick pony. We have a solid pipeline with four different programs. The program is mainly led by MASH, previously known as NASH. MASH is the fibrotic evolution of the fatty liver.
EL: We think we have a good shot at MASH. It’s a difficult indication, but based on our preclinical trial results, we still have a very good shot at MASH. Why? Because we act at every step of the disease. We have an activity on the fat deposition, we have an activity on inflammation, on fibrosis, on liver function, and, ultimately also on the risk of cancer. So, a good shot. It’s also an interesting indication because it’s a very large market opportunity with 36 million people affected by MASH in the world. Also, it’s a huge unmet need for those 36 million people affected with MASH. MASH is becoming all over the world as the first cause for liver transplantation. But, the market project is not limited to purely the disease itself MASH. Because of our approach to taking anti-aging drugs and applying them to this specific disease, we open up the door to very likely associated off-label origination benefits on other organs. We have the same market opportunity as Sarcopenia. Sarcopenia is the loss of muscle that you experience when you age.
EL: It’s a very bad sign because it increases your risk of cancer, diabetes, and cardiovascular disease. You lose the social links. It’s something important with no therapy. So also large market, unmet needs. In addition, we have the Werner syndrome. Werner syndrome is a rare progeria. It’s a disease of accelerating aging. It’s strategically very important for us because we want to establish as much as possible a pure anti-aging benefit. This is the acid test. If you can delay, stop, or even reverse aging in this population, that’s a perfect test for all of us. Finally, the force program is a program we do with dogs. There’s a very large appetite from the veterinary industry for life extension for our dog companions. Therefore, we’ll provide proof of concept. We’re starting this very soon, and once this proof of concept is finished, that should trigger an out-licensing deal with our partner in veterinary. I would like to thank you and move to the Q&A section. Welcome, Brad, to the presentation.
Brad Sorensen: Thanks, Eric. Glad to be here. Very exciting stuff. Yeah, life is the only 100% fatal disease that we have. Let’s, I guess let’s talk a little bit about, you know, everybody hears all these claims on TV, commercials on the internet, that this will, you know, take these pills, do this, it’ll give you a longer life, it’ll make your skin look better. You start to get numb to all of it because it’s like, yeah, this can all be true. In basic terms, we’re not PhDs here, can you explain a little bit about the science, again, behind what you believe is the anti-aging treatment that you guys are developing?
EL: Okay. That is an interesting question because when I say we understand the biology of aging, we understand it’s complex and multifactorial. No one should expect to have the magic bullet that will fix aging. It’s a little bit like cancer. You cannot say, oh, for cancer, there will be one therapy, and pop; it’s finished. It’s the same thing; it’s very complex, at least even more complex than cancer. So we start to have an understanding. It seems that now there’s a consensus to say that the root cause is our ability to repair DNA damage. Then, when you repair DNA damage, you have epigenomic modifications, and the cells lose their programation and lose their function. Then you have all those hallmarks of aging.
EL: It could be mitochondrial dysfunction, telomere, or senescence. All that is, in fact, linked with DNA damage. We think that genes play a major role in aging at our company. We all have this feeling because we see people with the same lifestyle and we see in couples some age gracefully and some age, it’s terrible. It’s become a tragedy. I’s mostly how your genome is able to deal with DNA damage. If you are lucky enough to have, for example, this mutation of Sirtuin 6, you may end up centenarian. The company’s objective is to share this mutation with everyone so we all have the same benefit as the centenarian. That’s mostly the basis of the approach with Sirtuin 6.
BS: Using that science, we’ll go into the treatments you have right now that are under investigation. So, as you mentioned, it used to be called NASH, but now the FDA has changed it to MASH. How does the science behind this translate into the science behind NASH and bring you closer to that goal of having a treatment for MASH now, which is a very debilitating disease and needs treatment very desperately?
EL: Yes, MASH is very interesting. As you know, neither the FDA, the MHRA, nor the European Agency consider yet aging as a risk factor for disease. So, therefore, we have to develop drugs for age-related diseases. The liver is particularly interesting because it is one of those organs that we can rejuvenate. If I cut half your liver, in six months, you have a regrown liver. If you’re a salamander, you can regrow many things. We have limited ability, but the liver is very interesting. It is also very interesting because, for gene therapy, you don’t need a lot of PKPD study bioavailability, to simplify a little bit, to be sure that your gene therapy will reach the liver. It’s the first filter and you will have a lot of your gene therapy there. I mentioned that we had a very good shot.
EL: I think we have a good shot. It’s difficult. There’s a lot of failures. One product has been approved recently. It’s a conditional approval. It’s becoming a huge unmet need with the first cause of liver transplantation. That gives us the possibility to have an accelerated pathway for development, which is very attractive because, for the investors, let’s say, the clinical development will be shorter and cheaper. We’ll have to produce fewer studies because it’s a huge demand.MASH is an evolutive disease. It’s difficult because it’s like shooting at a moving target. You have very good anti-inflammatory drugs, but they don’t work. You have very good anti-steatosis drugs, like the GLP-1, doesn’t work.
EL: We think we have a good shot because we act at the beginning on the fat deposition. There’s an anti-inflammatory effect, and there’s an anti-fibrotic effect that has been well identified after our discussion with the health authorities. We identified the novel mechanism that we presented on a poster and at the ARDD conference in Copenhagen last month. We have a positive effect on the hepatocyte function. This blocks the evolution to cirrhosis, and we even have an anti-cancer because, unfortunately, MASH ends up evolving into hepatoma, cancer of the liver. That’s a very interesting indication for us.
BS: Yeah, like you said, a very high need in the general public. I’ve dealt with other companies that have struggled to find cures or treatments for this condition. Let’s just back up a little bit. For the testing and the material you need, do you outsource that? Do you have your own laboratory facilities? Explain a little bit about how that process is completed.
EL: Yes, we are a UK-based company because we are listed on the London Stock Exchange. We have a subsidiary in the US, a subsidiary in Belgium, and most of the research is conducted in Belgium. It’s conducted in Belgium because we get a lot of non-diluting grants. Grants support 70% to 80% of R&D. So we are kind of a weird animal, I would say. We went to IPO very early, so, it’s all common shares. We don’t have venture capital that is preferred.
EL: We had a few VCs when we did the seeding, but they agreed to have common shares, plain vanilla, no loan, nothing, a small amount of money. We have a small market cap. We’re still very attractive, and almost 70% to 80% of the R&D, depending on the project, is supported by grants from Wallonia origin mostly, and Europe. So that’s an idiosyncrasy of the company that we are at the same time in three different countries, the UK, Belgium, and the US. Belgium, explained by the fact that we get a lot of non-diluting grants.
BS: Yeah, that makes sense. We will come back to that in a minute, but you mentioned one word that I’m going to jump on and ask you the question because it’s a very rare thing to see both. It’s a very rare thing to see the same company going after human treatments and treatments for dogs. Can you explain a little bit about how that came about and the idea behind it?
EL: Okay. I’m a dog owner, and that’s all my experience in the veterinary, but I will speak about that. You know that you have to do talks with two species. And when we first start our business plan, we plan one rodent and one higher mammal. We thought about dogs, and that’s very expensive, that’s very long. But in the initial business plan, you always put the worst-case scenario.
EL: The idea was to recycle the dog study, the tox dog study, into a proof of concept because contact we had with some vet pharma company, and they were saying that they are looking actively for a product that brings life extension for our dog companions. I thought naively that it was the old lady who didn’t want to die before a dog to die before her. Not at all. It’s a young couple. In my generation, I took my dog under the pressure of my kids when they were 14 or 15. Now they’re in college, and I still have the dog, no problem. Young couples are smarter than I am. They test their family unit with a dog.
EL: After two, three years they say, hey, we did a good job. We’re still together; the dog is well-educated; let’s get kids. Smart. Okay. The only problem is that the dog dies when the kids are five or six years old with this approach. That’s not a conversation you want to have here with our kids. That’s why it’s the core customer, so it’s a huge market. And they said, bring us any proof of concept, let’s have a deal. We’ll do the proof of concept, which should trigger a licensing agreement.
BS: Okay. So, the regulatory environment is less onerous for dog treatments. Can this be through licensing or some other means that bring, start to bring revenue into the company earlier and help offset the cost of the other trials? What’s the financial benefit of doing this?
EL: That will be wishful thinking. First, you need to have the money in the bank. Yes, overall, that’s the idea. To what extent, this depends on how strong our proof of concept is. It will take six months to conduct the studies. There are three months of paperwork. We need to do an analysis to present, so we have some time. We have the cash anyway and the runway to do all that. We’re not under pressure through our grant financing and the fact that we are a listed company. We have a long runway. But yes, we’ll see what kind of deal we can have. It’s now a very concentrated industry, the vet, so you don’t have a lot of people to discuss with.
EL: They’re bigger and bigger. So it’s difficult when a small company and, you know, partnership with a big company, and especially when you don’t know the space. I will be more in favor of pure licensing out than a partnership. We’ll see what will be the structure of the deal, including upfront payment, milestones, how much milestones, and how much royalties. It’s too early to say, but it should help to bring some cash, again, non-diluting cash, into the company and all of us when we are in clinical. We’ll need cash when we are in clinical with phase one/two in MASH study at phase one in sarcopenia, and one/two in Werner. So that will be welcome cash.
BS: There are a lot of costs coming up, for sure. I’ll echo your statements that I’m probably older than the typical dog owner who loves their dogs, but I know people who would rather spend money on their dogs than themselves. So that’s a market. Let’s talk about the financials. You’ve mentioned it a few times. Let’s get into it because investors need to know that. How much runway do you think you have? When are the human trials going to start? And do you have money to fund those trials, at least for the MASH? Kindly provide details so people can understand where you stand financially.
EL: Yes. So, for MASH, we are now in the IND enabling phase. That means we do the talks and the GMP production. We applied for grants from Wallonia for this. It has been discussed, and the money has been accepted. We’re still waiting for the money to be in the bank. As soon as we have that, we can be, so, let’s say, 18 months to start the clinical trial in Newman. We have the possibility, in addition to the grant every year, to have to issue 20% of new shares. There’s a lot of appetite from, otherwise, from investors, and every year, we try to sell 20% of our shares, which gives us a lot of comfort for the very long term. We don’t need any additional funding.
EL: We have some flexibility in terms of cost. The big costs will come from clinical trials. Then we’ll start with MASH; sarcopenia will come later. Werner can come pretty fast. We still have to discuss Werner with the agencies. So, I don’t want to tell too much about the timing of the clinical trial for Werner. I will tell the market once we first discuss it with one of the agencies. We’ll most likely conduct the Werner syndrome trial in Italy, in Northern Sardinia, where there’s a cluster of patients.
BS: Excellent. Yeah, that’s always one of the biggest questions when biotech companies are getting started and starting to bring things to trial. Will they have the financial resources to get there? How much overhead is there? How lean a ship do you run, how much do you control costs through employees? Those kind of things.
EL: The answer is very clear, as lean as possible. We finance mostly the company with grants. So that means grants only apply. You have a little overhead with the grants, but they are mostly for programs, so we spend money on them. We are lucky to have a nice scientific advisory board with passionate, competent people. We worked a lot with those people. Sometimes the board is kind of validation, but you just talk with them twice a year or three or four times per year, and that’s it. That is not our case. We worked extremely closely, and we conducted studies with them. We’ve done a lot of work with Manlio, Vera Gorbunova, and the University of Rochester, New York, and all the studies are supported by grants. Other than that, as lean as possible. We work on a virtual model, outsource a lot, don’t have a large team inside, and use a company called 2 Bridge that provides us if we need a tax specialist.
EL: We have a tox specialist for the next six months, and it’s closed. It’s as a consultant. Rather than having any in-house tox specialist, we have had access to a PKPD specialist through this company for the last 12 months. That gives us a lot of flexibility and viable cost, so we don’t have to commit. If there’s bad weather, if, I don’t know, something happened, the market crashes, and no one is, the government cannot pay the grants, we can, we have the ability to reduce the sales and go more slowly and be in cash preservation. We can also speed up and go faster with certain programs if we gain more. That’s the beauty of having a large pipeline with four different products. It’s safer in terms of risk, and it also gives us some possibility to delay one study and sometimes go faster, depending on the financial climate.
BS: Yeah, the diversity of the pipeline combined with the variable costs is a huge plus in this environment. We’re almost out of time, but I want to get to an investor question. We have an investor asking, “You have a strong background in being at the top of Nasdaq-listed companies. Do you see this company replicating that success, or is the focus on being bought out by one of the pharma giants?”
EL: The honest answer is, I don’t know yet. The cost of moving to Nasdaq is roughly three million per year. It’s three million, not direct costs, because the Nasdaq management fee is unimportant, but you have the exposure to some stocks, a higher D&O insurance, and many costs. Right now, it doesn’t make sense to spend three million. I just told you that the money goes to the R&D. If I put three million, you will say, man, you have to choose something. The approach we took was, rather than going to Nasdaq directly, which is finally the objective, to trade on OTCQB. It’s not associated with high cost, it’s a very nice option. It gives us the facility to, if necessary, when we want to, at least to Nasdaq. Nasdaq likes to see people with some volume and some people who are disciplined. Have you done your 8K, 10K, and 10Q, and have you had no problem with the SEC? That’s what’s important.
EL: Now, will it come first pharma acquisition or NASDAQ? I don’t know yet. What I can, what I know is for sure when one agency will move toward, okay, we recognize aging is a disease, we regulate this, pharma all of a sudden will look at us. The 10, 15 companies that are doing longevity, and there will be a massive wave of acquisition, bigger than what you’ve seen in immuno-oncology, bigger than what you saw for, with mRNA. That will be huge. It may happen in a year, in three years max. If we move very fast if things may before three years on Nasdaq, maybe we’ll wait three years. I’ve seen so many CEO of biotech who wants to go to Nasdaq just to say I did it. It’s a personal accomplishment. Yes, man, you did it, but with the investors’ money, it costs three million for your ego. The value of my ego is not three million. I can wait.
BS: Well, that’s good to hear. I think investors have a great story here. It’s an exciting company that is being run very well after analyzing it. If investors have questions, you can contact the company and their investor relations department. The information is available there. But for now, we’ll wrap up, and thank you, Eric. I appreciate it, everybody, and thank you all for joining us.
EL: Thank you all for your attention.
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