Hello, everybody. Thanks for joining us again. This is Rob Etherington. Happy to be involved with the Emerging Growth Conference. I'm the CEO of Clene Inc., and I'm joined by Morgan Brown, our CFO. We have a few moments here of update because a lot has been going on at Clene Inc. You see here the classical forward-looking statements that you're typically seeing, and we are making some of these during the course of this presentation because we've had a lot of FDA engagement of late. We've already announced much of this publicly. We announced last December that the FDA gave us a path forward with our NIH-enabled and NIH-sponsored expanded access protocol, whereby we were adding a new slate of clinical data to what we've already got. I'm using this slide just to ground us all.
Healy is the Phase II ALS double-blind placebo-controlled study in which we missed the primary endpoint, but nonetheless saw survival, clinical worsening, and neural filament data that was nominally significant in all of their pre-specified elements. Rescue is our nine-month Phase II double-blind placebo-controlled study where we missed the primary endpoint, but we saw clinical worsening consistent and concordant with what we saw in Healy. Neural filament was not assessed here. That was before we actually understood that neural filament was an important biomarker to study that program in as much as it started before Healy. Visionary is our Phase II in MS that resulted in a face-to-face meeting in August. Let's now just remind everybody, CNM-Au8 is an oral nanocrystal suspension. We're taking this by mouth orally, not we, but any clinical patient in our programs that is needing bioenergetic metabolite support.
You and I and the entire human family, as we slow down, that is a problem in general aging, but it is especially a massive issue in the case of neurodegenerative diseases like ALS, like MS. We have now quite a bit of safety data, which makes sense because we have the largest compassionate use ever attempted in ALS, numbering now over 500 folks that we have given free drug to as compassionate use. Frankly, equally relevant, maybe way more relevant, is our long-term treatment duration is now surpassing six years in some of these individuals who commenced taking our ALS asset, CNM-Au8, in 2019, and now we're in 2025. In a disease that uniformly kills individuals in as fast as two years once they're diagnosed, to have longevity at six years and counting is a pretty intriguing thing.
That is the reason, in fact, that we have been active at the U.S. Food and Drug Administration (FDA) talking about our endpoints. Just to remind you, we achieved a survival benefit in the pre-specified Healy secondary. We achieved an exploratory endpoint of clinical worsening, which in ALS is super relevant, defined as death or need for trach or need for a gastrostomy tube because I can't swallow food or water. Neural filament, just to remind everybody, if you're unfamiliar, as the disease ALS attacks the neuron and attacks the neuron in other diseases as well, but let's focus on ALS. As the disease ALS attacks the neuron, the neuron, as it dies, leaves a cytoskeletal protein remainder in the bloodstream. We can measure it. It's called neural filament light, and Clene has achieved a statistically significant, in a pre-specified way, benefit in neural filament light in the Phase II Healy study.
That data is linked to survival. In fact, we see for the high neural filament individuals, green is active drug, gray is placebo. We see an 83% and 84% risk reduction, so that's huge in ALS. We see for those people that have an ALS drop, we're about 2x placebo. For those individuals, they're the ones that are tied to survival. In other words, if you're on our drug and your neural filament is declining, those are the individuals that are having the strongest risk reduction, in this case, a P001 and a 91% risk reduction. Very, very relevant. On top of that, we've also announced against a regimen A control that we have long-term survival that was a 28% survival benefit.
In short, this is a very interesting period because we talked to the FDA in November about all of this data, and they said, look, let's get some more data to be a second proof source. We recommend you use to lever the persuasiveness of the Healy data, the expanded access protocol (EAP) data that you have underway with your $45 million that the NIH gave you to sponsor nearly another 200 individuals on CNM-Au8 with compassionate use. In that case of that study, which we commenced in June of last year and which we finalized enrollment in around January by literally the end of July, in other words, just two or three months ago, middle of the summer that we've just passed. I hope your summer was good for you as it was for us.
We have got all of those individuals now to six months at least of care, a majority of them at nine months, and as of the end of August, a good number actually also at a year. That data is right now under analysis to show whether or not the neural filament levels in those patients, all of whom had never had CNM-Au8, were placed on CNM-Au8 for the first time beginning in June, for the first time concluding in January. By July, August, they're all on drug for up to a year or thereabouts. That data is now being analyzed, and we'll be opening the envelope to understand if that neural filament is concordant with what we already showed you a few slides back in the Healy program here.
Especially just as an aside, as we announced in June with our FDA meeting that we held in June, we're looking at nine-month data. As we see here, these are the placebo individuals who converted to active drug, and then they started to decline once they converted to active drug as well. The original folks on active Clene from the beginning of the double-blind period and thereafter continued to have a demonstrably significant benefit through six months.
If we see concordance with this data from this extra data that we've just understood, in other words, a second proof source that neural filament is dropping at CNM-Au8, rather whilst on CNM-Au8, and if we can make the similar argument that these survival benefits that I've just walked you through are able to stay also concordant and be tied to neural filament drop, which is an argument that we've been, we think, successfully making with the FDA. If all of that is the case, then what that means is that we have the opportunity to potentially file a new drug application by the end of this year. If that's the case, then Clene could move into a commercialization preparatory posture in 2026. In that respect, we've got some cash ready to do that, Morgan?
Yeah, thanks, Rob. I mean, it's important to make sure that we have the financial resources to get through these super important inflection points that Rob has talked about. As a reminder, those inflection points are really in the next 60 days in which Clene is going to see these things, including neural filament light results that Rob talked about, a meeting with the U.S. Food and Drug Administration in December, and then most importantly, an NDA filing by the end of the year if all this data is concordant with what Rob has shown you. From a financial perspective, we've got cash now on the books that lasts us into the second quarter of next year. Sufficient cash to get us through all these inflection points, including the acceptance of that NDA post-filing.
Although you always want more cash, I think we've got sufficient cash to meet our needs in the short term with the opportunity to potentially raise additional amounts as we move forward through successful outcomes with these events. Rob?
Thank you for taking 10 minutes with us on this update. We look forward to outlining to the market the neural filament data when we receive it, which is again expected in the coming weeks. A very important fourth quarter for Clene . Similarly, the possibility of our filing a new drug application at the end of the year, top of the year, as we proceed through distillation of all this data we're now getting and coming to more of a fruition of this long journey we have had in ALS to see if we can help people that are struggling with ALS and possibly commercialize them in our drug. Thank you very much for your attention here and in October. We wish you well and happy fall.
Thanks guys.
Welcome back. We have an update from Lahontan Gold Corp. Trades on the TSXV under the symbol LG and on the OTCQB under the symbol LGCXF. It's a Canadian mine development and mineral exploration company that holds through its U.S. subsidiaries four top-tier gold and silver exploration properties in the Walker Lane of mining-friendly Nevada. Happy to welcome back President and CEO Kimberly Ann. Welcome back. We're excited for your update today.
Thank you. Thank you for having me. I'm excited to be back. It's been in the last few months since I've talked to you guys, we've had tremendous success. Our share price is up over 1,000%, even with this crazy little weird pullback we've had in the gold run that we've all seen. Very good for us. We've had massive liquidity in our stock. We purchased some new claims, which are very important for our company around our York pit. A lot is going on right now, and we'll have a drill breakout soon. If you've been watching any of my updates, yes, we're in the Walker Lane. Great place to be. It's very active right now. Our flagship asset, the Santa Fe asset, is, of course, a past producing mine. We have 2 million ounces on record out to the public at this point with 1950 pit shells.
This model was done at, which is we're adding a lot more ounces, just redoing our models and as well with our drill program that we did over the summer. Now we're going to start another one in the fall. We have one of the highest grades in the basin: 0.3 gold EQ. Of course, that breaks down to about 0.6 gold. This little chart, if you look at the slide, shows over the second highest in the Walker Lane area. Good grade. It's a lot of problems, and especially when we have awesome gold prices and silver prices as we do. That's super. This picture just kind of represents our Santa Fe pit. It's beautiful. The most important thing you can see there is all that orange stuff, that beautiful oxide that's just been sitting there since the mine closed down in 1994. It's well above the water table.
There's no dewatering issues. You can see the 50-degree pit wall, which is showing you that the rock is extremely competent. As the path is expected to be breaking from in Earth to mid-2027, it's very important to have all this data. As far as infrastructure, people ask these questions all the time. A substation on the property, three wells, road access all year round, and nothing grows out here. Our permits right now are going fantastic. We have two permits going at the same time. The plan of operations, we're currently in NEPA, and we expect to have full approval with that before the end of the year. That permit specifically allows us to drill our entire project out for the rest of the time, really, so we don't have to go back to the Bureau of Land Management to update that.
In parallel with that, the mine permit is going at the same time in the same footprint. All the bugs and bunnies studies that we spent a lot of time and money getting done are in that same footprint. It is fast tracking the company forward. When we talk about how do we add more ounces, it's very simple. We've been working under a notice of intent for a very long time, which means we only have five acres to work with. You can see in this land package we've added to it over the York area, all those blotches outside the black line, which was our current boundary. We haven't been able to report those ounces because they weren't actually on our ground. Now we have all this today. We closed that transaction finally.
Now we're going out in the next two weeks to start drilling over in this area because we believe that there's a lot of upside in this area with very good grade. All those blobs you see in the picture are just going to coalesce into massive super pits, and we're going to find more ounces through this next round of drilling. As far as catalyst going forward, we will be having all this drill information coming out. We'll also be weather-dependent drilling over at West Santa Fe and getting those results out to you guys at the balance of Q4 of the year. Q1 of next year, we'll be going into modeling all this up, putting in a new resource estimate, moving on to another PEA or PFS. We'll decide that in the next. That done in Q2. Lots of excitement.
If you don't know this story, it's a really good time to be in it. We have massive liquidity, so you can come in and out of the stock. I encourage anybody that's interested in gold and silver in the best jurisdiction in the world to at least sign up for our newsletters at lahontangoldcorp.com and just follow along with what we're doing and check it out. My email and phone number is personally on our website. For anybody that has questions, please reach out to me. It's very important for me to talk to any possible upcoming shareholders or current shareholders that we do have. That's what I got for you guys.
OK, great. Thanks, Kimberly. First of all, Carly says congratulations on the recent success. In a perfect world, what are you looking for next?
Oh, gosh, that's a big question. You know, look, we have great assets. We only are focusing on two of the four right now because money only goes so far. I will say we're making all our dollars stretch for multiple reasons of not having a big staff and being able to get a lot of work done with low-cost operations. I want to be a consolidator in Nevada. There are lots of assets that we're looking at. At the same time, when you have such a fantastic, perfect asset in your hands, you need to make sure anything you do, you're coupling properly with the company. Continuing growth and success with this company and fast tracking it to production and keeping our eye on the ball as much as possible to get this accomplished in the shortest timeline. Look, we have a government shutdown going on.
That makes things quite entertaining and challenging at the same time. That being said, I took measures about four months ago to sign up for contributed funds, which allowed me to basically have an account with the Bureau of Land Management, keep people working in case of a government shutdown, which happened. We still have our permitting team working our files. We are taking every measure to just fast track our own business as we look into this new year.
Perfect. Stuart asks, will you be issuing a revised feasibility study at current gold and silver prices?
Absolutely, we will. We're not going to do it until we get done drilling because we did a small drill program a few months ago, seven holes targeted in certain areas. We want to make sure that it's there for resource expansion. This next round is going to be extensive. We'll have that done by the end of the year and then get all those numbers back and, of course, put out a new resource estimate. I'm talking to several parties whether we're going to do another PFS or a PEA. The reason for that is the last PFS or PEA we did is very heavy engineer loaded because it's going into our application for our mine permit. It's the quality and depth of a PFS. We just don't call it that because of your 50-meter spacings accordingly.
We're going to go down the path of which one we need to do. Given that we're a passive producing mine, to build it and fund it, we don't necessarily need to go to the bankable study levels, etc. I used to work for a $5 billion fund. I am keenly aware of what needs to be discussed and needed for those types of situations to fund this project. Right now at current gold prices, oh, actually, not current, $3,500 gold prices, the payback was only 18 months. It's a dream sheet for a debt provider to give us as much money as we can take, less dilution for our shareholders, and pay it back in a short timeline.
Thank you for that. Stuart asks, how many ounces a year will be starting production and at what AISC? What are your annual ramp production estimates?
Those are all really good questions. I can't actually give you the numbers right now. Our last model, they're really not so accurate. I mean, that was an eight-year mine life, 55,000 to 60,000 ounces. All those numbers are changing from the metal work that was discounted by 12% project-wide because of just not new work being done, which we're doing now, to pit shells that actually capture all the ounces, dropping our pit shells down to 2,500, 6,000 ounces. All of that stuff is being put in right now, maximizing how many tons per day, et cetera. Look for that in Q1-ish, depending on my team, right?
Great. With that, Stuart asks, what additional key positions do you need to hire?
Oh, you know, at some point, we're going to have to hire a COO full time. Right now, we're working on contract mining assumptions because it's low risk for the company. We don't have as big of a staff, and we don't have to own equipment. It's just much more low risk, and the CapEx is massively smaller. As we move into next year, I'll be looking for a COO and a couple of other geologists. When we're doing small drill programs, it's all hands on deck at the drill rig getting this information because every dollar has to count to get to the finish line. I'm keenly aware of that. We won't bring a full-time one until it's necessary.
Last question from Sammy. What's the depth range you are drilling, and how much gold is on the shallow side?
That's the coolest part about this project. We've drilled down to about 380 meters, and it's all in oxide. It starts at the surface. Project-wide right now, the strip is 1.6. That might go up as we expand these pits into areas where there's some overburden, but that's the part about being in Nevada. It's super dry. Of 2,000 drill holes, we've only hit water in more holes over all the historic drilling. We're going to keep going and see what happens. It's all oxide right now, what we're drilling to date.
All right, Kimberly Ann, thank you so much for your time and update. We look forward to seeing you again real soon.
Thank you. Take care.
All right. Everyone will be back.