Welcome back, everyone. We have an update from 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 Chief Executive Officer Rob Etherington. Welcome, Rob. Before I jump into some questions, I would like for you to provide our audience with a short overview of Clene, specifically CNM-Au8, please. Thanks, Ana. Good to see you, and thank you for the audience for joining Clene once again. It's been a monumental week for Clene. A few days ago, we received our minutes from the FDA, our post-meeting minutes after our meeting that we just held with them. That was the fifth such meeting with FDA in the previous year and a half, all around the discussion about our clinical data. As Clene has announced, during the meeting and in the meeting minutes, the FDA has stated that the proposed data may be capable of supporting the submission and review of an NDA. There's still a lot of work to do, let's unpack what that means just a little bit. As all of our biotech followers know who follow this quite completely, Clene has extraordinary survival data. Survival data alone is not the secret sauce to really have an engagement with the FDA. To be candid, we thought so at the beginning, we missed the primary endpoint in the HEALEY study. The secondary endpoint was survival, we've sent the division a lot of survival data. We had not chosen HEALEY had not chosen survival as the primary endpoint. We've designed our confirmatory phase III around survival was not the primary endpoint. Consequently, what's left in terms of this key avenue is what I've just read, this notion of an accelerated approval, which basically means that there needs to be a surrogate endpoint. Survival doesn't count as surrogate, not in the way that the statute is given to FDA. We've been taught this pretty clearly. Survival, is it sufficient to approve a drug, just to be clear with everybody? Yes. Survival is strong data, clearly, but not for Accelerated Approval, only if you meet the primary endpoint. There's a little nuance there. That's a critical nuance. What we've done is okay because we've got a surrogate remaining, and the surrogate we're using is neurofilament light. Neurofilament light was achieved in the HEALEY study. We achieved a rough 10% improvement in neurofilament light in heterogeneous patients. That is to say, the 98% of ALS that is not the genetically compromised SOD1 ALS individuals. That constitutes about 1%-2% of the ALS individuals out there, and the FDA has already approved a different drug for those individuals. They're missing a gene, we give them a gene through a biologic replacement, and they're having a tremendous response. Indeed, it was actually the subject of a New York Times discussion this morning, a New York Times article in that instance. Clene is actually working to see if we could help the other 98%, but neurofilament is the thesis. As we've said before in this, we met HEALEY's neurofilament benefit, the agency asked us to go find a second proof source. In December, we announced that we indeed did that we have achieved 10% roughly twice. nine to 11, let me just put it that argument. Both were stat sig, both were achieved. That is what we're presenting to the agency. As we've stated in the press release on Monday, they want to make sure that we demonstrate that the effectiveness of CNM-Au8 is dropping the neurofilament, but more than that the magnitude of that drop, which again is about 10%, let's just average it there, is likely to predict clinical benefit. In the spirit of that, we spent a lot of time talking with the FDA about that clinical benefit. We've leveraged the HEALEY program in order to do so, and we've examined this question on multiple lines of evidence, looking at survival, looking at functional outcomes on the standard ALS FRS-R rating scale, which is function, and looking at all the ways the biomarker clinical concordance analyses tie together to investigate in our treatment groups that the neurofilament change tracks with clinical benefit. In our new drug application, which we're sending to the NDA, sending to the FDA through the NDA, new drug application, we're also looking at a number of other aspects to strengthen that discussion. Just to be clear, survival is the thing that cannot be unseen. We have a survival benefit. We've seen this in multiple different ways against placebo data sets, against our active patients in open label, against our placebo patients that convert to active, and against concurrent controls, which are other regimens randomized at the same time as us. That is the reason to believe, but it's not the reason to approve the drug. The reason to approve the drug is on a neurofilament path. In the spirit of that, we're putting all this together with the FDA. For Clene's regulatory focus, the HEALEY data set from Harvard is the primary data set. Then what we're doing is taking all that data and we're adding together multiple lines of evidence to converge on a single answer, and that is, does neurofilament benefit predict clinical outcome, which we believe it does. And we've submitted that to the data. Do we have a durable effect on function? Does it persist? Does it stay? Does the treatment benefit concentrate in neurofilament responders? Then finally, do we have a survival that tracks the neurofilament response? It's a very simple kind of one equals two equals three equals four period, but it's a lot of data that we've sent to the FDA. Back to the FDA itself. The FDA really is looking at the question: Does our neurofilament reduction show clinical meaningfulness, and is there enough there that they can review this dossier? We now are confident to believe that we can submit a new drug application to the division. They need to see all the literature, they need to see all the arguments, they need to see all of our data, they need to take the time to digest it all, and then they need to decide if they, the FDA, agrees with Clene's conclusions. That is actually the process of the submission of the new drug application. If they agree that we meet the filing parameters, which we are now preparing in all of its different respects, then they would, if they concur with the data we've sent, give us what's called a PDUFA date. That's a FDA adjective that basically means it's from Prescription Drug User Fee Act, so it's a date by which they would review the drug and then the date by which they would give a possible approval. We have said from the beginning we have extensive survival data. Is that helpful for this? It's the thing one can't unsee in our program. The survival data is paramount. What matters most of all is survival. Is it a way to approve a drug? No, it's not. Not with the path we're in. The neurofilament reduction is the way to do that. Clene remains the only drug in a phase II program to have ever seen in garden variety ALS, the 98% that I'm talking about, that's heterogeneous disease, a statistically significant neurofilament benefit, and we also saw it in the NIH-sponsored EAP program. Now taken together, we're taking all that data and submitting it to the FDA for this new drug application review process. Now, in terms of cash, when we announced this data, we had a lot of shares trade hands, and we had a new investor that wanted to come into the story, for which we are grateful. We were able to raise some money there. Then also, as we announced earlier, when our PDUFA date is given, if/when our PDUFA date is given, then that will be another execution of nearly $7 million. Taken together, this cash gives us, you know, a runway to continue through this process and to start preparing for the possibility, if everything goes to fruition and the FDA concurs with our data, for the possibility of approval next year. Ana, there's probably some more questions you have. I'll answer these. Great. Thank you for that thorough update, and congratulations on all this progress. We are a little bit out of time, but I wanna see if you have any next steps with the MS indication. Can you talk a little bit about that? There's been actually two dialogues with the FDA on multiple sclerosis. That is a key program for which we have a very interesting data, but there's no chance we can get an early approval for that. We need to do a phase III clinical study. The phase III study would be based on cognition for people that are already on MS drugs, tamping down their MS lesions, the MS lesions that cause them to have MS to begin with, but to work for people who are progressing MS and improve on cognition. That phase III design, we're actually working with a couple, number of advisors and experts in the space to put that together and having a dialogue with the same division that we're in front of for ALS, which is Division of Neurology 1, to talk about the execution of that phase III study next year. Wonderful. Well, best of luck with that. Such important work you're doing there at Clene. Thank you for this update again today, Rob. Can you hear me? That was a fast 10 minutes. That was a fast 10 minutes. Yep. It was. Thank you so much, and we would love to have you back on again real soon, all right? Okay. Thank you so much. Take care. All right. Thank you. Bye. Thanks. Bye