All right, welcome back, everyone. We have Clene Inc. They're back to our conference today. They trade on the NASDAQ under the symbol CLNN. Clene is a clinical stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases. I'm happy to welcome back CEO Rob Etherington. Rob, please take the next few moments and tell our viewers a little bit about Clene and give us some updates, please.
Thanks, Anna. Clene is a nanotherapeutic company. We just released data last week with respect to biomarker data that the U.S. FDA has been asking for. So just if you're unaware, a biomarker is, in the case of ALS, evidence of a damaged neuron. And the U.S. FDA, over four separate meetings over the course of the last 13 months with Clene, and with one scheduled in the first quarter, has basically laid out a path for Clene to take biomarker data as part of an accelerated approval pathway for the consideration of a commercialization of our lead asset, CNM-Au8. There's still a couple of steps still to do. The FDA asked us to validate and verify data that we'd seen in earlier studies.
And they asked us to do this in one of three ways: either find additional biomarkers, evidence of extra biomarker from the data that we have underway, or third, the possibility of new data from the Healey Harvard program. So taken together, Clene has decided to pursue all three legs of the stool, looking at the biomarker, presented this data publicly to the markets a week ago, and is now preparing a dossier of all of this data to take to the U.S. FDA for their review in the first quarter.
All right. Are you wanting to jump into questions, Rob? Let's do it. Let's see. Now, based on the totality of the evidence that you just shared, which was a summary of what was recently announced next week's, talk about the next steps.
So what we've done is sent this in a meeting request to the FDA to really try to review with them the three different questions that we've organized. Now, first of all, I think it's contextually important to understand these two biomarkers. One is, as the disease ALS attacks the neuron, it leaves a debris field that we can measure in the bloodstream, evidence of a dying neuron effectively. And it's called neurofilament light chain. And there was a drug approved by the U.S. FDA because of the benefit in neurofilament light chain a few years ago. ALS is a terribly... its impact, many clinical studies are short. And so what enabled is a pathway that we could look at changes in neurofilament light as this bridge to more data. In addition, the FDA suggested that we could look at additional disease-related biomarkers.
And another one is glial fibrillary protein, GFAP, quite well known in Alzheimer's disease, less well known in ALS, but it's a structural protein in an astrocyte that supports a neuron. And neurons, as they die, again, and as the astrocyte dies, it leads to motor neuron loss. So what Clene showed is statistically significant data in both of these two biomarkers. And so next steps are, to answer your question, we are taking, as I mentioned a minute ago, all this data to the FDA for discussion because the way accelerated approval in this country works, and this is the possibility of an accelerated approval as you continue to complete a confirmatory study, if you have a treatment... ALS is certainly that. And if you have a meaningful benefit over an available therapy on an endpoint like a biomarker that predicts a clinical benefit.
And so the FDA asked us to show that neurofilament light, as it rises, is related to compromised survival. And indeed, that's the correlation and the concordant data that we're preparing now for this FDA discussion.
Perfect. And so is the company in a position to file a New Drug Application shortly after the FDA meeting? And when might that occur?
Clene is preparing the new drug application of all of the data across all of our clinical program and our years of safety presently, incorporating this new data, which we just announced last week, in addition to other data that we will be discussing with the FDA in February, and then planning to submit in the top half of the year. A new drug application then takes a number of months to review, and so the possibility does exist if the FDA aligns with this data set via commercialization in the last half of the year, shall we say, this time next year, top of 2027.
So it depends a little bit on all of this data coming together the right way, of course, and a little bit, a categorically important bit, with the FDA understanding all this data and concurring with the collective approach that we've shown, which is that neurofilament light chain and GFAP change is statistically significantly reduced in the case of CNM-Au8 treatment, our drug, and that those reductions are related to survival benefit.
Perfect. And if you can share with our viewers what the accelerated approval process looks like, specifically timing and when CNM-Au8 might get on the market.
So the accelerated approval process is a matter of submitting an entire new drug application similar to full approval with one very important difference, and that is the company also commences a confirmatory phase 3. So as I mentioned a minute ago, we would do that in the course of 2026. That clinical study will take some time to recruit. We're building a study based upon survival as the primary endpoint. And that takes time to recruit that study and then have a sufficient number of events, which in this case is deaths, to show a statistically significant difference in the placebo category versus the CNM-Au8 category. In other words, a couple of years.
So the advantage of an accelerated approval pathway for a uniformly fatal disease like ALS is that the drug can come on the market based upon a surrogate, in this case, the biomarkers of which I referenced. And if the FDA concurs with that, then gives the FDA, or rather gives the company, the FDA gives the company a conditional approval based upon the conclusion of that study meeting in the positive when it is finished. And so back to your point, we'll be meeting with the FDA in the first quarter to discuss this process, hoping to file a new drug application shortly thereafter, and then having the agency consider that accelerated approval new drug application process over the course of 2026 with a decision that would come in the latter part of 2026, or maybe if they take some extra time, the top of 2027.
Well, good luck with that. Rob, are there any examples of other ALS drugs being approved and the market opportunity in terms of sales and what a projected market cap of Clene might be?
So presently, around the world, there's only a handful of drugs. And when I say a handful, I literally mean three in total, depending upon which market you're in. And in some markets, unfortunately, too many markets, only one drug. And so this is a relevant question because the most recent approval a few years ago was a drug in a very rare form of ALS called SOD1 ALS. It's only about 1% of ALS individuals. So in America, that basically means 300-400 people is all out of a 34,000 number of ALS people presently struggling with this disease. So very small slice. But the FDA did approve this drug based upon the biomarker neurofilament light for accelerated approval. And the company that sponsored that drug is now doing their confirmatory study. Otherwise, patients have very few options.
If you're the other 99% of the disease in America, you only have two options. One was approved in 1995. Another was approved in 2005. So they're both older drugs, 30 and 20 years old. And there's definitely a need for new therapies. With respect to the market cap, well, another surrogate approval of another drug that was temporarily on the market for a short period of time, about a year. They were on track to sell nearly $400 million of their asset before they had to stop their work in ALS. And that company had a multiple billion market cap. I think it was somewhere north of $2 billion from effectively nothing once they were approved to quite large. So certainly, the opportunity does exist that Clene's market cap would grow appreciably, appreciably emphasized if there was a commercialization approval by the U.S. FDA.
Wonderful. Well, thank you, Rob. And Morgan, thank you guys for joining us. And we really look forward to continuing on the conversation and the best of luck with this important work you're doing in 2026. Thank you, gentlemen.
Thank you for the time, Anna.
All right. All right, we'll be right back, everyone. And welcome back, everyone. We have an update from Faraday Future Intelligent Electric Inc. Trades on the NASDAQ under the symbol FFAI. It's a California-based global shared intelligent electric mobility ecosystem company founded in 2014 whose mission is to disrupt the automotive industry by creating a user-centric technology-first and smart driving experience. Happy to welcome Steven Park with the IR. And Steven, we're looking forward to your update today. So go for it and call me back when you're ready for some questions.
Fantastic. Thank you so much for having me here. Faraday Future, ticker FFAI. We're based in California. We're founded in 2014 by YT Jia. He's the legendary pioneer of smart TVs in China. He saw Tesla about 10 years ago and thought that he could combine kind of his experience with smart TVs to the automotive space, and the company went public in 2021, and today, we've invested $3.5 billion into R&D and CapEx, resulting in a portfolio of over 600 patents, and we work under two different brands. The FF, that's the vehicle on the left, that's our ultra-premium vehicle that's priced between $200,000-$300,000, and on the right, it's the FX, which is more of the luxury mass volume vehicle that we've partnered with Chinese OEMs, and again, we have a manufacturing site in Hanford that's near Sacramento and has the initial capacity of 10,000 vehicles annually.
And it could ramp up to 30,000 vehicles annually as well. So our unique business proposition is to be at the nexus of U.S. and Chinese electric vehicle makers. So we'll kind of get to the start here. I think we are a different business model. Some peers have looked at us and some investors are saying, "Hey, you guys look just like maybe Lucid or Rivian." And we have a different business model. We're partnering up with a Chinese OEM. So our economics are going to be different. Our gross margin target is going to be 10%-15% gross margin target. And the path to profitability on the cash flow side will be much sooner than any of the peers that we mentioned. So again, it's a different business model altogether. And I'll go through a few slides here over the next few minutes here.
We've talked about just a quick overview of the EV space. Right now, in our lineup, we have really two main vehicles, the FF 91, which addresses the market for over $100,000 electric vehicle market. And then the vast majority of the market is actually sub $80,000. And we'll be addressing that with the FX Super One. And we've mentioned in the past that in the lineup of the FX, we'll have another vehicle that's lower priced, the FX4, that would be sub $40,000. That should be coming out. But the predominant focus right now should be on the FX Super One. Again, just a quick overview of the two different brands. When you hear FF, that's Faraday Future. And the FX is Faraday X or FX. We've announced pricing on the FX, the FX Super One, at $84,000 in the UAE.
And that's going to be kind of our higher volume vehicle. And that's going to be the vehicle that we're focusing on with our Chinese OEM partners. Again, if you have a chance to see the vehicle, we were just recently at the LA Auto Show where we showcased this vehicle. It was a ride-and-share. Great response from customers and investors. I think they were very interested. We also received some additional pre-orders as well. But this is really a high-performance vehicle. It's got 6,000 lbs, 0-60 in 2.3 seconds. It's got nearly 400 mi of range. So it's just a beautifully designed vehicle. And again, if you are near our headquarters in Los Angeles, you'll be able to see this vehicle. We're in the process of opening up our office in New York. So we'll have this vehicle as well as the FX Super One.
I think just the pictures do not do it justice. You'll have to actually see it, and we'll give you a quick view of the interior here. Our designers, when you speak with them, their concept was to go seamlessly from either the workplace or your living room and go into your vehicle, and it would be a kind of almost seamless transition to your Zoom meetings or team meetings here. We've got a 27-inch screen, 5G connectivity. We also have software that is focused on AI that would customize based on facial recognition and also your phone, the additional kind of customized content for that specifically, so it's a beautiful interior. You'll see these captain seats. It's usually not something that you'd see typically. You're definitely not going to see this on Tesla, so it's a very luxurious vehicle here.
So we've partnered up with some of the Chinese OEMs. I'm sorry. And for the FF 91, we've partnered with some of the celebrities here. So we've delivered 21 of the FF 91s to celebrities, Chris Brown, Justin Bell. And it's really a social media platform for them to be able to share their experiences with the vehicle, whether they go to a high-end VIP event or they go to the supermarket or just daily use. I've talked about our Hanford manufacturing site. We've invested $300 million. This is the factory where we'll be doing the final assembly of the FX Super One. We do the body, the painting, and the assembly. And I'll just kind of highlight three unique business propositions for us. And these are our competitive advantages. I think one is on the tariff front.
So if a Chinese OEM were to bring their vehicles here to the U.S., it could face tariffs of about 200%. But by partnering up with us and doing the final assembly at the Hanford manufacturing site, the tariff on parts are about maybe 20%-25%. So that differential really creates an opportunity for us. And that's a huge competitive advantage. Number two is on the software front or on the regulatory front. By 2027, the U.S. will ban software in vehicles from Russia and China. But because we created the software for the FF 91 from the operating system, the applications, and the middleware, we can transplant that software to partner vehicles like the FX Super One and localize it for the U.S. market. So that is a big advantage. And the third is really we already have a dealership network and aftermarket services.
So again, if someone were to do that from the grounds up, it's going to take a lot of time. But we already have that in place. And we are at an exciting time right now. So again, here's our experienced leadership team. YT Jia, as I mentioned, he's our founder and Co-CEO. Strong entrepreneurial experience, a great leader. Matthias Aydt, Co-CEO. He's been in the automotive space for over 40 years at Porsche and at Magna as well. And Koti Meka. He's our CFO. He's got 20 years of experience in Ford. Jerry Wang is our Global President. And the team's been together for over 10 years with strong experience in the U.S. as well as China. And again, I think we've got three major competitive advantages. And we have a different business model. But that might be a good point to kind of pause here for a minute here.
All right. Thank you, Steven. Yeah, talk a little bit about some of the recent developments and some milestones you're going to hit in 2026.
Yeah, I think just three kind of real brief recent events. In the last month, we were participating at the LA Auto Show. Got great response there. And then even if you go back a month before that, we did the UAE launch of the FX Super One at the end of October. And just to remind you, we have 11,000 pre-orders. So we think there's a strong indication of interest there. And we are confident, our global president just came back from the UAE. I think he's more confident than ever. And then we also announced our partnership with Tesla to use their superchargers, the 28,000 supercharging stations, so in the U.S. So I think we're very confident about that. And then regarding key milestones, I think we'll have some additional milestones here that we'll announce.
The FX Super One pre-production vehicles will be coming off the line in the U.S. in the next three weeks. And we're already delivering these vehicles in the UAE. So we're in a very exciting time here. And over the next couple of weeks, we'll have some additional announcements and updates from our Hanford manufacturing site. And again, I think we're at a very exciting time point in 2026 as we get ready for 2026 here.
Perfect. Well, thank you, Steven, for this update. And we appreciate you and your time. And we definitely look forward to following along with more updates in the new year.
Perfect. Thank you for having me. Take care.
All right, everyone. Thank you so much for joining us on the conference today. This completes day one. But we'll see you back here tomorrow morning, 9:00 A.M. Eastern start time for day two of our virtual investor conference. Thanks for watching. See you tomorrow.