Good day, and welcome to Q2 Investor Summit Virtual. We appreciate your participation in today's virtual event. Up next, we are pleased to introduce Clene Incorporated. If you would like to ask a question during the webcast, you may click the Q&A icon button on the right side of your screen. Please type your question into the box and click Send to submit it. At this time, it is my pleasure to hand over the session to Rob Etherington, CEO and President at Clene Incorporated, who will lead the presentation. Sir, the floor is yours. Thank you. It's a pleasure to be with you all this afternoon. Morgan is going to drive the presentation. Morgan, I think you might need to go to projection mode. I think I am on projection mode. Did not see projection. Nope, I see the. I hit the projection mode. It's projection mode. It's the whole screen here. Hopefully, you can see everything then. A number of forward-looking statements are listed here by Clene. These are familiar with many of you. We're under no obligation to update these. We're grateful for the opportunity to speak to you. Next slide. They're not moving. No. It's not moving, Morgan. I think you need to share the whole screen, your whole screen. Really? OK, let me exit it here. Let's see. We'll try this again. Share entire screen. Is that what you want me to try that? Yes, sir. I hit Share, and nothing happens. Try this again. All right. Let's see if it's working. Can you see that now? Yes, now it's full screen too. OK, thanks, Morgan. Thank you, everybody online, for your patience. Clene is uniquely focused on improving mitochondrial health and protecting neuron function. The way that you and I move and walk and eat and chew and breathe, everything we take for granted every single day is this grand choreography of movement. Our particular problem that we're trying to solve is neurodegenerative disease is listed as one of the quite large therapeutic breakthroughs needed. We've solved a lot of things medically, but not neurodegenerative diseases. We're pioneering catalytic nanotherapeutics to treat Parkinson's, MS, and particularly ALS by targeting, next slide, the improvement of mitochondrial function. How we are building the case is we've completed a number of phase two programs, one in Visionary that we started pre-COVID, and then an ALS program called HEALEY, an ALS program called RESCUE, and then some translational work programs in Parkinson's and in progressive MS. Everything we're about to talk with you about is granted with patents plus trade secrets. There's a growing body of evidence that we have something most unique, and we have a number of regulatory conversations to have in the coming months. Next slide. The asset we're talking about is taken by mouth orally. It's a nanocrystal suspension. It targets, as I said earlier, energy metabolism and oxidative stress. It crosses the blood-brain barrier, and it's 60 mls in volume. That's about a quarter cup. If I was blindfolded and took a drink of a water glass versus our asset, it would taste the same. Next slide. What we're doing is enabling a support of mito function. The mitochondria under every neuron is driving, really, neuron function. There are two elements that are critical. Reactive oxygen species are an output of all of this energy that our body requires. Our brain is about 3%-5% of our body weight, but still, nonetheless, consumes a quarter of my daily energy requirements. In fact, if we could harness all that energy use, it would be far better than an exempit drug, for example, for weight loss. Our body is just using a lot of energy to keep the choreography that you and I require to move and walk and to eat and chew and to talk and to breathe. The neurons, against these assaults, must survive. Against what assaults? The assaults from a neurodegenerative disease such as, next slide, ALS or MS. We call the company Clene because we theorized from the beginning that we would have a remarkably Clene, safe toxicity profile. That is indeed the case. Over 900 collective years of participant exposure with treatment duration beyond five years now and counting. We see headache occasionally. We see nausea. On balance, we have a remarkably safe asset, which, even in the case of the nausea or the headache, goes away the longer you're on the drug. Critically, for drug development, we have not a serious adverse event related to Au8 in any of our programs to date. Next slide. This becomes very relevant because we've had a number of regulatory interactions. We have, in particular, three FDA interactions over the course of the next quarter or so. We completed a nine-month study called RESCUE, a six-month study called HEALEY. We have many expanded access protocols, actually four in total, that are enabling compassionate use of our asset. We missed the primary endpoint in RESCUE and in HEALEY. Unfortunately, for ALS-paid people, we are not alone with that miss. 20 different pharma companies have missed their primary endpoint in the last couple of years. We did achieve, you see some green check marks, we did achieve survival. We did achieve clinical worsening. Next slide. We did achieve the biomarker neurofilament. Our time to event survival data from the secondary endpoint in HEALEY for 30 mgs was significant during the six-month double-blind period. Next slide. Continuing robustly, actually even after individuals moved on to active drug. Next slide. In addition to that, across both HEALEY and RESCUE, we see clinical worsening improvements that were statistically significant, 71% and 74% risk reduction at p-values of 0.1 and 0.3. Now, Clene worsening in the case of ALS is whether or not I need a tracheostomy cut into my neck so I can breathe mechanically with a machine, whether or not I need full-time breathing support because my lungs are too weak to power my own breathing, whether or not I cannot swallow food or water anymore so I need a gastrostomy tube and to take all of my nutrition and my liquids by feeding tube, or whether I die. Those are four evident, pretty obvious elements of Clene worsening. Clean, in the exploratory influence of both studies, was positive. Next slide. Now, this is neurofilament. It's probably new to most of you. It's very relevant, though, because as the disease ALS attacks the neuron, the neuron disintegrates effectively or falls apart. And there is a cytoskeletal protein remain that is entering the bloodstream that we can measure. It's called neurofilament light. In ALS, high neurofilament is very predictive of greater risk of disease progression. Next slide. What we saw in the HEALEY program is, in a pre-specified way with both serum and plasma, we saw statistically significant during the double-blind phase in a pre-specified fashion neurofilament benefit. The only such statistically significant improvement, actually, in a phase II clinical study. That continues robustly through the 12-month open-label extension, still significant even after the individuals on placebo convert to active drug. Next slide. This becomes very relevant because we sent to the FDA some data linking plasma neurofilament with clinical benefit and understanding time to death or permanently assisted ventilation, which is to say a machine breathing for me for 22 hours or more a day. We saw that for those individuals with the upper tertile of neurofilament, so the top third or the top half, in both cases, we saw an 80% plus risk reduction with a statistically significant benefit. Next slide. We looked at just how well we can decline neurofilament and found about 2x of the patients versus placebo had a neurofilament decline. Of those decliners, we saw that there was an improvement in survival, in fact, 91%. Any individual who is declining, there is a distinctive difference at a p-value 0.01 separate from neurofilament. If you have a high neurofilament coming into our program, those are the individuals that our drug is helping survive longer if also the patients are seeing a reduction in neurofilament. Next slide. We also talked to the agency about real-world expanded access protocols, of which we have a number in place presently. This data here, 36 and 33, reflects two different EAPs and long-term data against natural history controls, also significant survival benefits. Next slide. In the compassionate use program, we also saw a significant benefit of survival. Next slide. Taken all together, this became very interesting a few months back because we also saw improved AUA long-term survival versus a Regimen A concurrent control. Just to give some context, when we originally recruited Healy, there were three programs that started together, Regimen A, B, and C. Regimen A and B were two different pharmaceutical companies. Unfortunately, the Regimen A program was negative. They had to stop the study at three years and move everybody to different therapies. We have that data as a concurrent control. We saw a survival benefit that was significant there as well. If we follow this data, like our phase three design, we see that it's even more significant and more reflective of a survival benefit, in fact, in this case, about a 49% risk reduction. Now I'm going to shift gears and come back to ALS in a second because there's a lot of regulatory discussions underway. I'm going to now give you the same drug, 30 mgs of CNM-Au8, same dose from our Visionary multiple sclerosis data. This was a one-year study that we actually started before the ALS work. We then got slammed tight, shut into a brick wall, like many of us, by COVID. We have 92% of the patients here treated with the DMT. By consequence, these individuals had an immune system that was tamped down to prevent more MS attacks. Those individuals that have their immune system tamped down to prevent MS, the last thing they wanted to do was to go into a clinic with lines of COVID people. We had the good fortune of doing this in Australia. Their COVID impact was a little bit delayed from the United States, for example. We were only able to enroll about half of the subjects before COVID slammed the program shut. We got them to a year of data. We expected we'd see nothing. By nothing, the primary was a change in low contrast letter acuity. The secondary was a cognition and fine motor change, a composite endpoint. This is the result. What we see is a P=0.56 on vision, which has just missed the classic 0.5. We pre-specified a threshold of 0.1 with the FDA in a half-enrolled study because we thought we'd see nothing. We were thrilled to see the P=0.56 on vision improvement for about three letters or so. The secondary endpoint was, as we see, a composite endpoint of cognition and vision, as well as fine motor. What was interesting is we followed these individuals, next slide, for two further years. We see that their improvement in total number of letters tracked to nearly eight letter improvement. On an eye chart, there are five letters on an eye chart. All of us are familiar with eye tests, whether or not we wear contacts or glasses. To be able to reread from across the hall an eye chart is pretty impressive, including, as you can see on the right side, the placebo individuals. They converted to active drug. They replicated the same. Why is this happening? It's because we're improving the amplitude and the latency of the signal. What that basically means is we're getting more signal with more speed because we're remyelinating the optic nerve. This was proven through visual evoked potentials, a paraclinical biomarker that checks that speed and the amount of information my eye can process to my cortex. Next slide. Very important. We also had cognition improvement. This is for MS people that struggle with MS, one of the key market needs, a cognition change, because many MS patients have had some compromise in their white matter of their brain. By consequence, they complain about cognitive fog, just kind of a blurriness, as it were, cog fog, they often refer to it as. As you see here, we had a pretty interesting improvement in the SDMT test, an amount of benefit that is the equivalent of individuals being able to go back to work again. Next slide. That occurred because we show through MRI that we are remyelinating and improving the axon integrity. Even the placebo individuals, they are getting a benefit, an improvement. Next slide. We have just released a bunch of correlation data at the American Academy of Neurology in April, mid-April, so six weeks ago. This data was significant across all of the parameters. We were showing that those individuals that had improvement in remyelination and in the brain's neural protection are the individuals that actually had benefit and it correlated together. Next slide. What's next is actually to talk to the FDA about ALS. We already announced this publicly in December. The FDA suggested that we gather more neurofilament data from our expanded access protocol, which is ongoing from a $45 million grant from the government through NIH. That data actually is all coming to us in the summertime of this year, of at least six months and some individuals up to 12 months. The FDA proposed a plan that we're talking with them as we've announced this summer to actually review that data in a statistical analysis plan that was pre-specified and to see if it's concordant. If it is, the possibility exists to talk to the agency about a surrogate accelerated approval path with neurofilament as the surrogate. In addition to that, we're submitting all this survival data to the agency to have a twofer discussion, survival and biomarker, and see if that would warrant an NDA that we could submit by the end of the year. Excuse me. In addition to this, changing gears, we have an end of phase II meeting planned in the second half of this year to discuss MS because MS cognitive improvement remains a massive opportunity, as I've stated already. Across a couple of different indications, a couple of different FDA conversations will teach us for the regulatory path going forward. In the meantime, we've leaned into partnering discussions for the multiple sclerosis franchise, whereas because partnering can help pay for an MS clinical program that we would need. The ALS program, if the FDA aligns to the survival and neurofilament path, could be a concordant or rather a confirmatory phase three that we would need to do with a possible accelerated approval path. We'll find that out in the coming months. Next slide. In short, we have Au8, which is a gold nanocrystal suspension. It's remarkably in development as the world's first nanotherapeutic to remyelinate and protect neuron function. We've shown you a lot of data from both ALS and MS studies with a lot of safety, well over 900 collective participant years with a single, not a single, not a single, not a single. I repeated that three times on purpose. Serious adverse event related to drug and strong IP. I'll let Morgan speak to the fiscal path. Yeah. We wrapped up the first quarter with nearly $10 million in cash, which is sufficient to get us through probably October, which is beyond all these interactions with the FDA that Rob just shared with you, as well as really getting that neurofilament light data from our expanded access program, which will be the basis, that and survival, for allowing us to file a new drug application. We continue to explore ways to extend runway, whether it be in the equity markets, off an existing shelf registration statement we have or ATM, or through non-dilutive means like Rob mentioned, through partnering licensing transactions where there would be some upfront capital associated with those types of transactions. In short, it's going to be an exciting next probably three months with all these interactions with the FDA and more importantly for the data readout related to neurofilament light. Assuming all of that is positive, we plan to file an NDA by the end of the year. With that, we will open it up for questions that the audience may have. Thank you, Rob and Morgan, for the presentation. For the audience, you can ask your questions on the chat box, please. They're happy to answer any questions. If you do have a question, I guess just add it in the join the conversation box, and we'd be happy to answer that question. It doesn't appear like there's any questions out there. Yeah, I think so. I think we can now close the presentation. I will just play the closing one sec. That concludes Clene Incorporated's presentation. You may now disconnect. For details on upcoming presentations, please refer to the conference agenda. Thank you for your participation, and we look forward to welcoming you to the next session.