Welcome back, everyone. Next, we have Clene Inc., trades on the NASDAQ under the symbol CLNN. It's a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases. Happy to welcome President and CEO, Rob Etherington, and CFO, Morgan Brown. Welcome, gentlemen, to the conference. We're happy to have you today.
Thank you.
Thank you. It's a pleasure to be back at Emerging Growth.
All right, the floor is yours.
A number of your listeners may be familiar with Clene. It's kind of crunch time here. We expressed as much in our dear stockholder letter of yesterday. I think, though, if some of you are new, listeners, that is, it's worth taking a moment to do a quick introduction of Clene, and I'll get into the essence of our, of our story. First of all, if you're in the Northeast, I hope you're digging out from a big snowstorm. Morgan and I sit just against the mountains of Utah, and if you've been following the Utah ski situation this year, we need your snow. Sorry that you have to unbury in New York and Boston and Rhode Island and elsewhere, but feel free to send it to us. We want as much snow as you can give us.
We also need as much help in ALS as you could possibly give us. Many of you have seen, with great sadness, the loss of Eric Dane. He was a good friend of mine. I know him very well. I've been with him many times. I love that man, and it is a tragedy, the way ALS took him so quickly and so aggressively. I wanted to start today's Emerging Growth with our sorrow, sympathy, and prayers to Eric's family, Rebecca, and his two lovely daughters. This is a classic case, though. ALS needs desperate help, and Clene is right now in front of the agency in the upcoming weeks, as we announced yesterday, to work to see if we can get the regulatory flexibility that this disease must have.
I'll get into that a little bit later, but wanted to take a moment to acknowledge. In fact, we lost two friends last week within 24 hours of each other, and this cannot happen. A diagnosis happens too late, people deal with systems too long before they get diagnosed, they can't get on therapies generally, and this must change. Let's now get into this a little bit more, what's going on here? First of all, if you're new to CNM-Au8, I'm holding here the asset in my hand. If I was blindfolded and took a drink from my water glass, I would not be able to tell the difference. This tastes like water because it is effectively mostly water. That is a crazy thesis for many. What is it? It's a nanotherapeutic suspension. Nano means super small.
We're talking so small to cross the blood-brain barrier. When I, if I were to drink this, which I'm not doing, but our patients are, nearly 800 of them have, and right now, through 4 different expanded access protocols, we have treated over 500 individuals with compassionate use on top of the clinical program. In any event, if they were to drink this, they would not be able to tell a difference. They're drinking trillions of nanocrystals. What are those nanocrystals doing? They are driving right across the blood-brain barrier, the ability of the neuron to take care of its own housekeeping. I want to go forward a few slides to express my next point. Biomarkers have become super critical.
Now, most of us don't think what a biomarker is, but all of us have heard of the word cholesterol. Cholesterol now is commonly measured in a laboratory at my primary care doctor with simple blood tests, and if my cholesterol is high, my doctor gets very concerned, and he puts me on a statin. Similarly, now that I'm a guy of 59 years old, my doctor also would get concerned if my prostate-specific antigen is too high. Tells him and me my prostate's in trouble. Neurofilament is similar. If I have a blood test and my neurofilament is going high, then I need to batten the hatches, become very concerned, and be very worried about what neurodegenerative disease is wreaking havoc in my body.
Especially that's the case in ALS, because neurofilament is the debris field effectively of a damaged neuron, and it correlates very directly with faster progression and short survival. It's released when the neuron is pummeled, when it's damaged, and I can measure it in the bloodstream and in the CSF. Neurofilament becomes really relevant because it is a key path for Clene. Now, jumping back to where I just was, for those of you that don't know, Clene and every other ALS drug, mostly every other ALS drug in the last 100 years has missed the primary endpoint, ALSFRS. Survival was the endpoint for years, decades, but nobody could achieve survival, so we moved in the field to ALSFRS. Stands for ALS, amyotrophic lateral sclerosis, functional response scale. It's a measure of function across 12 domains.
One domain would be, can I eat and chew my own food? Can I feed myself, swallow it on my own? That's a domain, and if I'm successful at that, the way you and I hopefully ate our breakfast, where we could feed ourselves, chew, and swallow that food, that's a 4. If I can't do that, it needs all my food and water need to go into my mouth through a gastrostomy tube because I can't chew and swallow, that's a 0. Another example is if I can dress myself or handle my own bedclothes, get into my bed, pull my sheets, adjust my pillow, and go to sleep. That's a 4. If I can't do that, somebody else needs to help me do all of that, then that's, you know, progressive, less numbers all the way down to a 0.
ALSFRS has really only been met by 1 or 2 drugs worldwide, and Clene, like multiple other drugs in the last few years, missed that primary endpoint. We did achieve, as evidenced by this slide with the green check marks, survival. We did achieve preserved function, we did achieve the exploratory of clinical worsening, and we did achieve the biomarker benefit. This becomes super relevant because survival matters in ALS, especially given how I opened, talking with tragedy about the loss of our friend Eric Dane, but also others that died this last weekend. We saw, as the pre-specified secondary endpoint in the HEALEY study, a 94% risk reduction. The FDA saw the data, and they wanted more evidence than a singular secondary study.
We said, "No problem." That's been the discussion with FDA over the last 14 months. We also showed FDA clinical worsening data from 2 studies, but it was the exploratory endpoint. Again, clinical worsening, defined in ALS's case, is whether or not I die, an obvious element of clinical worsening, but also whether or not I need breathing support mechanically, or, as I said a minute ago, a gastrostomy tube because I can't swallow food or water. If those 2 things happen, I need to start having air hunger, which means I can't get my breath to power my body, or I can't get food or water unless I do it through a tube. Those are huge entrees to clinical worsening, even up to death.
That is the thing that's really trying to happen here, is we're trying to avoid clinical worsening, so we can avoid survival. The key thing is back to the biomarker. Clene also found in our pre-specified, double-blind, phase II HEALEY, a neurofilament statistically significant benefit. The only drug of the 8 programs thus far completed in HEALEY to have showed a pre-specified neurofilament statistically significant a difference. The agency's like, Well, hold it. That's 1 example, and it's 10%. We said, "Okay, what do you want?" They gave us 3 options. They said, "You can choose 1 of these 3 paths.
You can go look at your EAP study," that is the NIH-sponsored Expanded Access Compassionate Use Program, in which we have about three times the data because we have about three times the patients in that program, that $45 million that the NIH gave us. That's option A. Go see if you have concordant, similar, parallel data in neurofilament from EAP, or look at the placebo people, that after the 6 months, this gray line, they went on drug and you followed them, did they have a benefit in neurofilament? Third, go look at another ALS-specific biomarker and see if you had a benefit there. Let's start at that third option, GFAP, Glial Fibrillary Acidic Protein. I showed you on the left of this screen what that is all about. That is a structural protein in astrocytes, crucial for supporting the neuron.
When I measure that in my bloodstream, it shows that I've got a degenerative process going on that is contributing to motor neuron loss. As a patient, I do not want to see neurofilament or GFAP levels at all, let alone rising. I want them to go down, because that means that my neurons, rather, are benefiting by the drug and are helping my disease progress. In the spirit of that, back to this slide, you see here that the pre-specified neurofilament on the left and the GFAP that we pre-specified with the agency, we would go look at the data. We had no idea previous to this. We see nearly identical p-value, both 04s, and nearly an identical reduction, 0.90 versus 0.89, 10% or 11% change.
That brings me to kind of the second pillar of this. Does even as modest of a 10% change in ALS matter? Yes. We showed this data in a press release on December third, matters immensely. We're working on a publication, and that question, does even modest changes in neurofilament drive survival benefit, became roughly half of the very extensive dossier we submitted to the FDA in December. Continuing here, the agency said, "Okay, well, does neurofilament and GFAP matter if they move together?" The answer is: They moved very much together, first of all. We see p-values of 0.001 with respect to the 6-month, 9-month, or 12-month reduction. We see a very consistent reduction, meaning that if you're on our drug and your neurofilament drops, measured at 6 months and beyond, your GFAP is also dropping.
You saw that in the previous example. You see it here. What we also showed is, does baseline neurofilament matter and baseline GFAP matter? In this case, we looked at the top quartile and the top tertile for those that had the best declines on neurofilament and GFAP, and we see here an 80% reduction that was seen in survival for those that had the best response on neurofilament and GFAP, both significant at either of the tertile or the quartile. We've already shown, if you've been around Clene for a minute, we've shown 6 months ago or so, that we showed twice the neurofilament reduction.
For those folks that just had any neurofilament drop, if we follow them out for a year, we see a 91% reduction in survival with a p-value of 0.001. That's why there ends up becoming a lot of evidence here just supporting the thesis of neurofilament and GFAP as a biomarker being tied to survival. Again, the agency gave us a couple, you know, legs of the stool to consider. Do you have other biomarker benefit? Does reduction in neurofilament matter, and can you tie it to survival? As you've seen from these three elements, there's a yes in all of that, but critically, there's something else, and that is the survival data is quite relevant if we follow it against even larger concordant or rather, concurrent randomized controls.
If, again, if you've been around the block with Clene a minute, you've seen this data previously from Regimen A. This data we showed the FDA in September. They commented about it to us, when we received the final meeting minutes, in third week of November. This is what we showed them. We showed them that we took the HEALEY protocol, the 480 odd subjects that were recruited originally, and then randomized into A, B, or C. Those 480 subjects that were chosen had the same Clene trial sites, 57 across the country, the same eligibility criteria, the same inclusion, exclusion, the same master protocol, the same follow-up. They were then randomized into either Regimen A, B, or C.
They went on an active drug in Reg A, an active drug in Reg B, or they went on CNM-Au8, our Reg C active drug. We're looking here at the covariates, in other words, how well were these patients randomized? It worked well. There was only two examples where there was apples and oranges as opposed to apple and apple. You see here, these eight examples are apple to apple. There's two examples where it's a little apple and orange, that is, how their function was at baseline and how their neurofilament was at baseline.
If we look at these two datasets, everybody, the apple and apple, and if we adjust to make the apple and orange, apple and apple, which is the comparable risk set, we see here in either case, a 73%-77% risk reduction, both at a p-value of 0.01 at 12 months. This showed something very critical, that there's a survival benefit as another evidence from the original 6-month double-blind program. That becomes very relevant because as we looked at this and looked at it for longer term, because we had a lot longer term to look at, data out to 36 months, 3 years, we see that that survival benefit remains durable. It endures. In fact, in the apple and orange, adjusted to apple and apple dataset, we see a 44% risk reduction with a p-value of 0.004.
The agency looked at this data that you're seeing here, and they said the following. I will read to you what they said: "Clene, if you're able to provide," I've already announced this, by the way, in a previous press release.
If you're able to provide substantiation of the effects of neurofilament light, we would be willing to consider the six-month data from HEALEY," which I'm going back to that slide, is this data here, and this is the 94% survival p 04, "and the post-hoc analyses on survival," which is all of this other survival I've shown you, including this data here out to three years, "as capable of providing evidence that the change in neurofilament light." Going back again, sorry for the slide move, but I just want to make sure you're tracking what I'm saying here.
The change in neurofilament light," which is here, "as reasonably likely to predict clinical benefit and serve potentially as confirmatory evidence." They also asked us to see if we could give them further data on this, including Regimen B. All of this data has been sent to the agency as a large dossier, and as we announced yesterday, in my dear shareholder note, we're right now waiting for the agency to hold a meeting with Clene, and as we announced the timing of same, that this dossier was extensive. The timing didn't work exactly as we thought. There's a lot going on at the agency, as you certainly know. You've read this in multiple headlines, including an op-ed in the Journal this morning, and more data from the Commissioner of the FDA, Marty Makary, yesterday.
You know, the FDA is following, to some degree, its own timetables. We're grateful for all the work they're doing. We're planning for this meeting. We're taking opinion leaders with us to it. This meeting will be occurring, and we can't wait for said meeting, because what we're planning to talk about there is survival, and biomarker, and the relevance of small changes matter immensely for survival. Modest changes matter immensely. Clene has arguments on all of these, and significant in all these cases: survival, clinical worsening, neurofilament, pre-specified significant changes matter. The agency's going to have to exercise a little reg flex, a little regulatory flexibility, because accelerated approval is the path we are seeking, and that requires a confirmatory Phase III.
A confirmatory phase III is what we have planned, and the hope here is, as we've shown and talked about, is that we can provide patients access to CNM-Au8 as early as around this time next year. The reason we speak to that is because if I'm about to have my meeting, and I'm expecting to announce the final meeting minutes of that in the second quarter, and I'm soon to file thereafter my New Drug Application, and if the FDA gives me a PDUFA, and if the FDA reviews this drug in their classical 6-to-8-month timeline for an orphan asset that has designations such as Clene's does for ALS, that leads to the possibility of a commercialization at the top of 2027, somewhere, again, this time next year in the first quarter.
That means, too, that we can start helping and commercializing in sporadic heterogeneous disease, an asset, and help physicians diagnose this disease earlier. People like our friend Eric Dane can get diagnosed earlier when symptoms occur, and that there is a lot of developing therapies that regulatory flexibility should be required for a disease as heinous, as devastating, as extraordinarily compromising to the patient as amyotrophic lateral sclerosis is. The time is now to actually provide regulatory flexibility, and we are so grateful that over these last 14 months, the agency has met with us 4 times.
We are super grateful for all the dialogue we've received, and we sit here at this key moment to see if we've given the agency sufficient data to discuss multiple biomarker analyses, and to be quite prepared to run a confirmatory Phase III study. Let me have Morgan take a moment and talk about the finances, but I want to just spend a minute on MS. We have not forgot about MS, categorically not. We believe that this asset is a pipeline and a product. We showed the FDA all of this data you're seeing now, where we saw vision improvement, cognition improvement. We saw it sustained also, same drug, same dose, for three years out. We saw the placebo individuals who converted to active drug had a similar benefit in vision improvement and in cognition.
We talked to the agency in August. We reported already that data in September. We'd like to go to a Phase III study. We need to do that either with ALS commercialization funding or partnership funding. Such a study will cost us, but we think there is a deep market need to take this asset in MS individuals who are otherwise have controlled their MS lesions, but still have a vision or cognitive impairment. We're working with the agency now to basically adjust three decades of precedent, where the agency has used a primary endpoint of EDSS, that stands for Expanded Disability Status Scale, and to rather look, in Clene's case, at cognition improvement.
We think that's the market need. The agency has already had a number of back and forth with us on the MS side, so we're simultaneously working on that. Again, most of you are, and frankly, Clene, are entirely focused on ALS, because ALS is the devastating mortality that we'd like to see if we can resolve with survival, and biomarkers as the path. We just announced in January that we have a fair amount of cash runway. Morgan, do you want to talk about this?
Yeah, happy to do that. Hopefully, each of you guys heard the excitement in Rob's voice. I mean, I think both he and I, as we get closer and closer to hopefully filing this NDA, that excitement level increases, and we're hopeful that, you know, we'll have a positive interaction with the FDA this quarter and then be able to file that NDA, as Rob mentioned, by middle of this year. Most of you guys are probably wondering, does Clene have enough cash to get through all these really important milestones? The answer to that, to Rob's point, is yes. You know, roughly a month and a half ago, we entered into a very interesting sort of structured transaction in which we raised, you know, minimal amounts now, but enough to get us through and into the fourth quarter.
gets us through this FDA Type C meeting, it gets us through an NDA filing without any problem at all. Like I said, we raised $6 million at $6.50, and then we actually structured this financing such that we have 2 additional tranches of financing that would come into the company on regulatory success. The first one being an NDA filing, and acceptance of that filing, not approval, just acceptance. That would bring in another $7 million, which would stretch our runway into early 2027. Upon approval, the second tranche of financing would hit, which would raise another $13 million, which would carry our runway well into 2027.
I think, you know, as you look back and step back and say, number one, we've got a lot of exciting things happening here in the very near term, and we have the finances that allow us to get through those milestones and fund the company adequately to get to these success points. With that, Anna, maybe we open the remaining time we have to some questions.
Thank you, gentlemen, and thank you for acknowledging the loss of Eric Dane. I'm sure many of us grew up watching his work. I know I certainly did, so our thoughts and prayers are with his family. Let's remind our audience, please, Rob, some upcoming milestones for ALS, and specifically, what do you expect the Type C meeting to occur with the FDA and those meeting minutes?
We just announced yesterday that we're expecting, the Type C meeting to occur by the end of the month. Again, there's kind of three-
The end of the quarter. The end of the quarter.
I'm sorry. Very sorry. Thank you. Thank you. The end of the month of March. Thank you. I'm already thinking March, Morgan. Thank you for that. The end of the first quarter. By the end of March, we'll expect that meeting to occur, and that's why we've also announced similarly that we're going to see the minutes in the top of somewhere the second quarter. There's basically a couple doors that could be opened there. Door one is the agency say, "We've given you the whole dossier, we're ready to go.
Let's submit this NDA." Door two is the opposite of that, which we really pray doesn't happen, but that is: "Go do your Phase III and come back and talk to us in a couple of years." Door C is: "Well, you've given us so much data, it's hard for us to really comment just this moment, but we'll be willing to accept your NDA, to kick the tires, dissect the engine, look at the data in our hands, and then let you know if you have a PDUFA date." That's probably the most likely catalyst. To your point, by the end of the quarter, we'll have the meeting. In the top of the second quarter somewhere, we'll have received those minutes from the FDA, we'll report them.
We're expecting to file the NDA by the end of the second quarter, if all these timelines work. Then, as we've stated, there could be a PDUFA date somewhere in the third quarter, because the FDA's rules are, once they receive NDA, they have 60-72 days to review that. Then there's a review process that takes about 6 months. That's why altogether, we're saying, we're kind of a year out before we could be commercialized.
Perfect. What readout should investors expect in the next six to twelve months, and how do you define success for each?
Well, the core readout, which every investor cares about, and frankly, Clene, is what the FDA thinks about this asset and this data. Will they let us file? Will they give us a PDUFA date? Will they approve the drug? Those are the three critical ones. If I just narrowed them to 1, 2, and 3, does the agency agree that there's enough biomarker data here, that there is enough argument of these three stools? Is there biomarker data? Is it concordant throughout more than one data set? Does that biomarker data matter because it connects to survival? That's the way we're kind of thinking about it, because that's the way they've thought about it. That's the way they've expressed it to us in their minutes, as we've stated previously.
If they agree now that that volume of data for a disease such as ALS deserves accelerated approval, regulatory flexibility. You know, Marty Makary has said, even in the last three days, about the criticality of orphan rare diseases, and that the FDA needs to be a beacon for the world in helping rare diseases, get new drugs. If that applies in his mind to ALS, and if the review division agrees that our data also applies to ALS, then off we go to the races, and we're about to find that out. We're working hard, we're praying, and frankly, the excitement is, you know, Clene, feels confident about this data, so we hope we have, you know, two of these positive doors and are not told, "Come back and talk to us in three more years.
Perfect. We do have more questions for you, but we are out of time. Do you have any closing remarks for our viewers today, Rob or Morgan?
Sorry for not giving questions. We're happy to take individual calls with investors. I think what we've seen here is we've got data that we obviously feel pretty compelled about. If you sense excitement because we feel we have compelling data. We have a phenomenal safety profile. We have survival in nearly every group we assess. We have statistically significant neurofilament change and biomarker change, and we are super grateful that the FDA is engaged with Clene. Stand by because we'll be reporting about these engagements with agency.
Wonderful. Well, keep up this important work. We appreciate you coming back on the conference today.
Thank you.
All right, everyone, we'll be right back. Heme Solutions. They are dedicated to addressing the global blood shortage. Happy to welcome the founder, Jonathan Barkman. Welcome to the conference today, Jonathan. We're very excited to hear your story.
Here this afternoon, I'll jump right into it. Heme Solutions has developed a universal oxygen carrier. The problem here in the United States and throughout the world is we have a substantial blood shortage. In 2022, the American Red Cross issued its first-ever blood crisis. Again, in the middle of 2024, the Red Cross issued a national blood emergency for the shortage that we have in the United States with the lack of blood transfusions. One in seven hospitals are short with blood as needed. The world in total is short 120 million units of blood per year. Every two seconds in the United States, a unit of blood is needed for a transfusion.
There's many challenges in the blood supply chain: inventory management, shortage in transportation, testing and screening, donor availability and recruitment, emergency preparedness, communication and information sharing, and the regulatory compliance. The solution is our universal oxygen carrier. We've developed a carbohydrate technology that's able to be attached to a heme from a hemoglobin of a camel. That in turn is several thousand times smaller than the actual human blood cell that's able to transfer oxygen throughout the body as needed when donations are not available. It's universal, compatible with all blood types. It's shelf stable at 5 years at room temperature. It has no side effects, and when it's in the body, it has a half-life, which means it's delivering oxygen for 12 hours or more. The universal oxygen carrier is sterile, it's easy to transport, it does have a long shelf life, and it's low cost.
The effects is it has oxygen supply to the entire body and also improves organ quality. It's designed to mimic the human red blood cell. The MDXViewer. We have a licensing agreement with a device that's already approved by the FDA that measures oxygen in every cell in the body. Unlike when you go into the doctor today and you measure your oxygen by putting a clip onto the end of your finger, that measures the oxygen that's inside of your pipes. This device right here measures oxygen from every cell in the body. Therefore, when we're taking our universal oxygen carrier through the FDA, we will prove to the FDA that we're moving oxygen around the body with a device that they've already approved. After the MDXViewer, I would go right into our budget and overview requirements.
Our next slide would be our budget and overview requirements. For our first year, we'll be working with the FDA for our preclinical submission. We'll be manufacturing enough product to be able to handle our FDA human trials. Those will happen inside the United States at so far, one of two places. We can go into assumptions and valuations here for a minute. Just keeping it inside the United States, the valuation could be several times... I'll go back here for one second. Our next slide, we can go into assumptions and valuations. I'll let the audience go through that on their own. The market's huge inside the universal blood market as far as a blood substitute.
If you would start to break into the hyperbaric chamber market or other oxygen therapies, it would obviously go much higher. Next slide, we can go into leadership and management. I'm the CEO and founder of the company. My background is accounting and finance. I spent 15 years as a registered financial advisor, and the last 15 or 20 years, I've been focusing more on private equity, which led me into the position that I am here now. Dr. Platt, he's our Carbohydrate Technology Chemist that's been working on this technology for more than 40 years. He has a platform of different drugs that have been working with the carbohydrate technologies. We have Boaz Shalom. He is the biochemist that has our camel farm in Israel.
We are getting our hemoglobin out of a camel, and that's coming from our farm in Israel, and that's coming from Boaz. Next, you have Alex Edwards. He's our business specialist, and his background is coming from the United States Navy and does a lot of work in other companies, mostly on the sustainable energy side and sustainable products for the U.S. That concludes my presentation here this afternoon. Thank you. I look forward to your questions.
All right. Thank you, Jonathan. Wonderful. Congratulations on all this. This sounds so amazing, and it kind of blows my mind. Talk about what other uses you can use this for?
Well, sure. I think the first market we'll go into would be the blood substitute market. Initially after that, I think we're going to look into the hyperbaric chamber market and other oxygen therapy markets.
How much research is left, and when do you think you'll get this approved and start selling?
Great question. The research is actually done. Our chemists and their team have been working on it for more than 20, 25 years as a blood substitute, artificial blood substitute, and the carbohydrate product going back more than 40 years. The research is complete. As far as sales are concerned, I think inside the United States, it could be 2, 3 years until we get it through the FDA. We are working with a couple different channels here inside the United States to get it fast-tracked. We're also working with a couple different countries that may have a use for it before the United States would approve it through our FDA.
Can you explain this in a little bit more detail to me? Will this replace blood transfusions, and where might you manufacture this product and distribute it?
Sure. It's not going to take away from blood transfusions. Technically speaking, it's not blood at all. It's only oxygen. What it will do is take care of the 120 million units a year that we are short for blood and free up real blood or transfusional blood for clients that or patients that actually need real blood versus just oxygen.
In your view, what's the major implication of this technology in healthcare, not just in the U.S., but worldwide?
It's going to be used for emergency use, for when blood is not an option. There's still parts of this world that have a very significant shortage of blood. I think we'll reach those first. just being available and the ease of access when traditional blood transfusions are not available, there's uses beyond that, you know, beyond recognition for right now.
Since there is no current market for just a universal oxygen carrier, how is the company gonna spread this idea across the industry?
Again, great question. We have a little bit of time yet. We are discussing, maybe a partnership with a couple different countries, a couple different companies inside or outside the United States. That would probably be our main goal, to get it out as soon as possible. As soon as it's ready, we would like to implement it as quick as possible. If a partner with an outreach of, 50 or 100 different countries at one time, that would greatly benefit us.
Typically, FDA approval is expensive, and it takes a long time. Do you see a path under the new and revised FDA that can speed up this process of approval and maybe reduce the cost?
Absolutely. Our cost to final product and getting it approved is slightly under $10 million, but I also think that we'll have enough help along the way now that we're getting ready to file our patent, that I would imagine there'll be some grant money and a lot of help coming our way.
Is this an investment opportunity? If so, talk about the valuation, and will you be going public?
The valuation, I think I'm going to let the market take care of the valuation. I'm not sure if we're going to go public anytime soon or not. We have initiated an investment banking firm to help us raise our future capital needs. I don't think I'll be going public anytime soon, at least for another two to three years.
If our viewers want to learn more about this, what should they do, Jonathan?
Sure, they can just reach out, to me on our email or, find us through the website. I'd be happy to answer any questions.
Perfect. Well, thank you so much for your time and presentation and important work with this. We appreciate you, and we look forward to seeing you again in the near future.
Thank you. I appreciate it. Thank you for having me.
All right, everyone, we'll be right back.