All right. We would like to welcome back Clene Inc to the Emerging Growth platform, and joining us today is Rob Etherington, CEO and President, with Morgan Brown, the CFO. Now, Clene is a clinical stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including ALS and MS, so I'd like to turn the next eight to 10 minutes over to Rob to share some accomplishments of the company, and then we'll jump into a Q&A. Welcome, Rob and Morgan. Thanks, Anne. It's a pleasure to be here again. So Clene's just announced literally a week ago, just previous to the JP Morgan Healthcare Conference that we attended in San Francisco, during which we met with a number of investors, that we have achieved, been granted our in-person meeting with the FDA this quarter. And this is absolutely critical. This is the fifth time we've met with the FDA in literally 14 months. We met with them in November, and then June, and then August, and then September, and then now we're meeting with them again this quarter. And the point of all these meetings is to literally discuss the extensive biomarker and survival data that Clene has achieved. As we announced in early December, we showed FDA-recommended biomarker analyses that were significant in reductions of both neurofilament and a new biomarker, glial fibrillary acidic protein, that basically happens as the disease ALS attacks, in the case of neurofilament, the neuron. In the case of GFAP, glial fibrillary acidic protein, the astrocytes, and in both cases, as the disease attacks these neurons and we lose the ability to talk to muscles, then these are biomarkers that show up in the bloodstream and in the CSF. Clene is measuring it in the bloodstream. And we show that these biomarker improvements were strongly associated with longer survival. Now, this is an important point that I'm not sure has been fully understood. Why all these discussions with the FDA?, well, first of all, in the HEALEY study, we missed ALSFRS. This is the endpoint of Amyotrophic Lateral Sclerosis Functional Rating Scale. It's a measure of function. We're not the only ones to have missed that endpoint. In fact, if you just did a simple little AI question, how many ALS drugs have failed in the last 30 years, you'd get the answer 80-100. And if you looked at the last two years, it's actually 18. Nobody's achieved ALSFRS except for Amylyx. And that story is, frankly, unfortunately a little famous. That drug was withdrawn because it couldn't confirm such benefit. But if we'd have chosen survival as the primary endpoint in the HEALEY study, we'd be having a very different discussion right now. We didn't, however, so we need to take our lumps there. But that's why we're in front of the FDA so extensively is because something is going on. Repeatedly, in every one of our press releases, we show a demonstrable survival benefit. So in short, we've been granted this Type C meeting to discuss all these newly completed analyses with the singular intention to actually file a New Drug Application under the accelerated approval pathway. Now, let's be clear about what that means in case you're not. A biomarker is a surrogate endpoint. So in other words, if a pharma company misses its primary endpoint, then there is this option created during the AIDS era, so decades ago, where a company could consider a surrogate endpoint. And the surrogate we're talking about in this case is a biomarker, in this case, neurofilament light. And we're not pioneering. The FDA's already approved another drug in ALS, Biogen's Tofersen, named Qalsody, on neurofilament light benefit alone, now only for 1% of ALS folks, so 300-400 patients in America. But the way this accelerated approval thesis works is we have to basically prove you've got a rare disease that needs a medical advance. ALS is definitively that. There needs to be a confirmatory phase III study in an accelerated approval. Clene's announced multiple times we're prepared for that. That study will be built on survival. And then finally, that there is a thesis that the company is pursuing to show that the biomarker is tied to a clinical benefit. And the agency says specifically this to us, as we announced in the press release, that if you can show the biomarker is tied to a clinical event such as survival, then we'd be willing to consider all that data if you show the biomarker themselves. So that's exactly what we're doing. We've kind of approached this as three legs of a three-legged stool. Prove the biomarker benefit is substantial and significant and concordant, and in this case, we've given the agency not just neurofilament, a key focus, but other biomarkers that moved in lockstep. GFAP, as I've stated in December, and insulin-like growth factor binding protein, which we stated last week, actually, just previous to the JP Morgan meeting. In both cases, we see connection to survival with these data. In both cases, we see a concordant response for individuals that are on our drug, and especially in GFAP, we saw this direct connection between the way the neurofilament was dropping and the GFAP was dropping. Then the second leg of the stool is prove that neurofilament and its change, its increase, or more relevantly, its decrease is independently associated with mortality, and so we've done exactly that. We've sent the agency a fair amount of data to show them that CNM-Au8 consistently reduced neurofilament levels. We saw it in HEALEY, the Harvard study, and we just demonstrated it last month in the EAP program. Then we've showed them also in our dossier that neurofilament reduction is quantitatively associated with improved survival, that even modest reductions in neurofilament and heterogeneous disease, which is to say all-comer ALS, not just this 1% of a genetic defect, but the broad outline of ALS generally, that if we see a reduction of 9%-10%, which is what we saw in neurofilament, significantly proven in the full data set across two data sets, HEALEY and our compassionate use, that that is similarly associated with a lower risk of death. The larger the neurofilament reduction in this data, the more proportionately greater survival benefit. And so that is related because that brings me to stool, or rather leg three. Excuse me, I lost my train of thought. Leg three of the stool is to show that the clinical benefit of survival is consistent and solid through the data set. And so that's why, again, in the vision here, we've sent the agency all three pieces of these elements to really make the argument that we have multiple complementary statistical methods. We have multiple concordant data sets. And let's send it all to this division. So in the spirit of that, we sent them all that data in December. And as we announced last week, the FDA has granted us this meeting later this quarter. And so we're going with all this data, both exploratory and that which was pre-specified in pre-filed statistical analyses plans with the FDA over the course of 2025 to review this in its aggregate. And this will all culminate in a meeting. And the intent of this meeting is to say, "Agency, we've given you all three legs of the stool. We think we've hit a home run in all three cases. Do you agree, Mr. and Mrs. FDA?" And if they do, then we'd like to file a New Drug Application. Wonderful, Rob. Well, congratulations on that. Thank you for that very important update. So remind us when this meeting with the FDA is? And jumping ahead, assuming they're aligned, when do you anticipate Clene being in a position to file an NDA for ALS? So again, the way it works is that we asked for a Type C meeting with the full dossier we sent. We sent 105 pages of this data I've just given your viewership some insight to. We sent that in December. The agency then granted us this meeting this month in January for later this quarter. So by the end of this quarter, we'll have completed this meeting. It's going to be an in-person meeting where we're traveling with our advisors, which include key opinion leaders in the ALS space and biomarker experts to meet directly with the FDA face to face across the table there in their White Oak FDA facility in Maryland. And again, as I stated, at the end of this quarter, we'll have had that meeting concluded by. And they're reviewing our data set now. And then what will happen next, Anne, to your question, is if the FDA concurs with this data satisfactorily meeting their request to, A, confirm a biomarker, B, show us that confirmation in a couple of different data sets, three, make sure that biomarker decrease is relevant to survival, and four, all that survival data, these are kind of the legs I speak to. Then what we do is what we'd like to do and what we intend to do and what we are asking the FDA for our plan to do is file a New Drug Application asking for accelerated approval. And so that application would then go in in the course of the second quarter. We'd hear an answer back from the FDA as to whether or not it's accepted sometime in the summer. If accepted, that could lead us on a commercialization path for the top of next year. Literally, if I was speaking to your viewership, at this time next year, a New Year's resolution for Clene would be, "We'd like to approve CNM-Au8 with the FDA's blessing for ALS people across this great country of ours. Best of luck with that, truly. Quickly, talk about your recent financing and who participated in that financing along with your cash runway. Morgan. Yeah. I mean, we announced this the Friday before JP Morgan. So all these events are sort of happening at the same time. But we were very blessed to be able to extend our runway an additional quarter through the financing that we announced about a week and a half ago now. We raised roughly $6 million at $6.50. But it was a tranche financing. And that was on purpose because we wanted to make sure that we had appropriate runway at each of these steps that Rob talked about in terms of NDA acceptance and then NDA approval. So that $6 million we raised was what we raised now at $6.50. But we look forward to the next tranche that's potentially $7 million at $7. And then the last tranche would be triggered upon approval, which would be at a $12.50 strike price and would raise about $15 million. So this financing was really pivotal to be able to allow us to say that we have funding in a positive scenario through approval. So very grateful for that. And in terms of the investors that participated, there were three main dedicated healthcare investors, very well-known healthcare investors, including Vivo, excuse me, Castellan, and Boxer Capital. So very grateful for their willingness to partner with Clene and see us through this exciting journey that's to take place the next year roughly. Wonderful. Well, any closing remarks, Morgan or Rob? I was just going to say thank you for all investors for keeping track of what we're doing. With this survival data, ALS patients definitively need this. We have 30,000+ ALS patients in this country. We right now are also working to reapprove, reauthorize a key package at the Congress level to fund more ALS research in the future. There's multiple patient associations doing this because thousands of patients are diagnosed every year. Presently, uniform mortality without treatment of two to four years. Definitely, new drugs are needed. It's been 90 years since Lou Gehrig was diagnosed. We still have effectively just one key drug that people are prescribed. That needs to change, and we are very grateful for the FDA being willing to entertain our potential applications as the next possible drug. Wonderful. Important mission you're on. Thank you so much for this great update, and we look forward to continuing on into 2026. Thank you, Rob and Morgan. Thank you. All right, everyone. We'll be right back with our next presenter.