Hey, we're back. It's 9:30 A.M., and a week ago, this was Virios Therapeutics. Now it's Dogwood Therapeutics. Not a reverse merger, it was a merger that took place that left Greg Duncan, CEO of Virios, in the driver's seat of the NewC o with a drug that they brought on board, Halneuron, which we'll talk about. But the Virios assets are still there, IMC-1 and IMC-2, and all of the important work that's happening at the Bateman Horne Center in the long COVID study. Yeah, we're still... That data, I think, has got to be almost imminent at this point. For investors that are not aware, over the summer, there was some activity in Congress, believe it or not, on a bipartisan level, talking about putting funding into long COVID, and I think that's important, given all of the data, particularly from groups like Greg's that are showing it's, you know, viral reactivation may be having a substantial role in driving not only long COVID, but other fatigue-related disorders, including fibromyalgia and other things that we can get into. So Greg, welcome back. I think it's been a bit of a whirlwind for you, I'm sure. So I think it would be helpful for everybody, including myself, because we've been in the middle of this conference when the Dogwood transaction was announced, and kind of walk us through top-down what took place, and where is the company now, looking forward? First off, thank you, Jason, for inviting me to participate today. As you referenced, we announced a transaction about a week ago, and the transaction is a business combination that brings together two companies, Georgia-based Virios Therapeutics, and Vancouver-based WEX Pharmaceuticals, into the combination now known as Dogwood Therapeutics, which incidentally, transacts as DWTX, as a new Nasdaq ticker, DW, Dogwood Therapeutics, DWTX. We are focused, as was Virios Therapeutics, on advancing three late-stage assets now, not just two, that treat pain and fatigue-related disorders. Germane to putting this transaction together was the expansion of our pipeline to include Halneuron, as you referenced. Halneuron is a very novel NaV1.7 modulator. It inhibits, voltage-gated systems, which reduces pain signaling, and in particular, Halneuron is the focus of a Phase IIb program in chemotherapy-induced neuropathic pain. We can get more into the background to this particular disorder, but suffice it to say that there's nothing approved to treat chemo-induced neuropathic pain right now, so there's a very significant unmet need, and we believe a very significant commercial opportunity that resides in this particular space, presuming continued development success. In addition to Halneuron, we certainly have IMC-1, famciclovir and celecoxib. The combination antiviral is a treatment for fibromyalgia, and as you just referenced, Jason, IMC-2, valacyclovir and celecoxib combination antiviral therapy to treat long COVID. And as you mentioned, we're expecting in the coming weeks to unveil the top-line data from this very unique long COVID trial. It is remarkable to think that there's probably 85,000 people worldwide who are still contracting COVID on a weekly basis. Million. Upwards of a third of those patients... Yeah, it's a, it's a huge number. I don't think people really appreciate it. What's unique here is that about a third of those patients, or upwards of a third, go on to contract Long COVID, and I think as time has gone on, as you reflected, the bipartisan progress on the Hill, people are recognizing how- You got a taste what we can get from there, so- Yeah, indeed. Indeed. It's not really the acute COVID that is the problem these days, and no disrespect to mortality rates associated with long COVID, but long COVID's really the higher level of morbidity that's associated with the disease. So we're very excited about those data, which will come out in the next couple of weeks. Concurrent with the transaction, which is very important, we had a strategic financing by CK Life Sciences International. They are a Hong Kong-based entity. They've provided $19.5 million as part of the strategic financing, which when combined with the cash of Virios and WEX, gives us a little over $23 million, just under $24 million to operate the company, operations, and research. Importantly, this allows us to get through a very important interim readout for the Halneuron Phase IIb program in the second half of next year. That CKLS entity is actually an institutional shareholder affiliated with noted Asian investor Li Ka-shing, and we believe that the addition of a stable, long-term focused shareholder to our existing shareholder base is a very important part of this transaction. As you referenced, we'll talk about the product in some more detail, I suspect, as we go through the discussion today. This is a team that will be led by the Virios Therapeutics management team. We have extensive experience in pain-related disorders. In fact, it is our team that developed and/or commercialized drugs that you know today, Celebrex, Lyrica, for example, in the pain space, and we hope to bring that expertise to bear, to bring Halneuron to CINP patients who desperately need new therapies. So that's really the background to the transaction. What was the genesis of the transaction for the, for WEX, for the other side, to move Halneuron forward? Well, I mean, obviously, you guys have the expertise in terms of your- Yeah ... experience with pain and fatigue, but how did it come up? Yeah, I think it's. If I were to really simplify it into a very simple schematic, Jason, it is their drug, Halneuron, they're putting capital to advance the drug, and they're putting our team at the lead to advance that drug at a more efficient level. We are revising the program. We think there's a more efficient way to execute the trial, and I think the expertise of the team was noted by CKLS, and they brought those resources together. The upside for CKLS is now they have a team that can run this faster, potentially more efficient from a capital perspective, but they also now have access to IMC-1 and IMC-2 as shareholders in Dogwood Therapeutics. So it was an expansion of pipeline in both directions. Can you talk about how Halneuron, its mechanism of action, you had mentioned, voltage-gated channels and reducing pain- Mm-hmm ... as well as chemotherapy-induced neuropathic pain for people who don't understand what that is? Sure, sure. So, Halneuron is a NaV1.7 voltage-gated inhibitor. Effectively, there are, I believe, nine NaV pathways. We believe 1.7, from a Dogwood perspective, is the most relevant. And by inhibiting that particular signaling pathway, we decrease the pain read-through for patients in a variety of pains, but certainly for something like chemo-induced neuropathic pain. What's unique here is this is highly differentiated. This is a highly differentiated approach. The mainstay of therapy for cancer-related pain, both general cancer-related pain, as well as CINP, is actually opioid therapy, which is a very bad fact. I don't think we have to tell anybody listening today the downsides to opioids. So this novel mechanism is supported by both preclinical and clinical data. In the preclinical side, we're really impressed with one of the particular animal models they ran, where they actually showed that Halneuron worked faster and was as effective, if not more effective, than duloxetine, which is a drug that's noted as very effective in controlling neuropathic pain. So there's great preclinical data to support this particular mechanism. In addition, Halneuron has been shown in two trials to reduce pain. There's a broader cancer-related pain trial, where they show a statistically significant reduction in pain in patients with broader cancer-related pain, as well as effectiveness in chemo-induced neuropathic pain, which is a dose-finding, regimen-finding study, where we've identified the dose that we think will make the most sense for patients as we progress Halneuron going forward. What is unique here for this particular asset is the duration of effect. We are seeing an average duration of effect in the cancer, general pain study of about 60 days, 57 and a half days of effect after the last injection, which is a very nice, durable effect, which is hinting to, which we need to explore, some type of more permanent or mechanistic change, structural change. That's after a single injection? That's after a four-day regimen. After that last injection, the average effect in the broader cancer-related pain program was about 57 days long. So it's a very nice duration of effect. I should mention, everybody knows somebody who's had chemo. The vast majority of patients who have chemotherapy go on to develop some form of neuropathic pain. I think it's about 65%-68% have some form of neuropathic pain. In fact, we do know of a patient we just spoke with over the last couple weeks walking up to the transaction, that was actually packed in ice as she got her chemotherapy regimen to avoid the progression to neuropathic pain. What is interesting to us is that six months after the stopping of chemotherapy, there's about 30% of patients who still have neuropathic pain. It seems to be a lasting effect, a more permanent effect, and we really believe this is where Halneuron can have a dynamite effect. It's a very large market. The cancer-related pain market is $5 billion in total. The chemo-induced neuropathic pain model is about $1.5 billion. So the company that gets it right, and we hope we are that company with Halneuron, has an opportunity to not just reward patients with a good clinical effect, but has a very significant commercial opportunity. The cancer pain market itself is $5 billion? Yeah. Our estimate is the total market is $5 billion. If you take the slice- And that's steroids, opioids, and such, right? I mean, it's not- That's... Yeah, there's nothing really approved to treat chemo-induced neuropathic pain. There are very limited options for cancer-related pain, and our guesstimate, excuse me, our estimate is that there's about a little over a half of those patients, of that $5 billion, are related to treatment with opioids, which is just a bad fact. Right. We understand the side effects, the withdrawal, the addiction potential. In the prior clinical trials, or even in the preclinical work- Mm-hmm ... was it in a setting for opioid sparing, or was it head-to-head with opioids, or was it just placebo? Yeah, so we do, in the trials, have evidence of opioid sparing, certainly from the particular trial. There's a variety of reasons that people stop opioids, so I think if you look at the research historically, that was a very key marker, sparing of opioids. But I think we've learned over time that effectively, people stop opioids for a whole host of reasons, side effects, et cetera, so it may not be related to that therapy. What I can tell you is that we did observe a reduction in opioid use in the broader cancer-related trial, when those patients were assessed over the course of their treatment. So we do think that could be a nice benefit of Halneuron, is to reduce opioids, but the real goal here is to get rid of opioids, to get Halneuron to be used in place of opioids. That's really the goal here for the development program. ... is there any impact on respiration with Halneuron? We have not seen any evidence of respiratory effect. The tolerability profile of Halneuron appears to be very good. We see some numbness in the tongue through this particular mechanism, but we do not see any respiratory effects. And in fact, the WEX team that precedes Dogwood Therapeutics actually did a QT study as well, and there's no cardiovascular effects on this particular asset as well. So we're very intrigued by that tolerability and safety profile. Were there any patient dropouts in the prior studies that you're aware of? There are dropouts. We do see a dropout rate that's commensurate between drug and placebo. So there's really no difference in the two in the regimens, which was another attractive part of the profile. Okay. Is there a utility for this drug in post-operative pain? Because that seems... In the pain space, that seems to be a go-to indication for pivotal studies. Yeah, we think the NaV1.7 mechanism has utility in a host of chronic and acute pain settings. We will obviously, as we've communicated, start with CINP as the first port of call, but we do think there are other chronic states, broader cancer-related pain. We do think there's acute pain states, post-surgical could be one of those options. And in fact, we've recently filed IP around a unique contact lens formulation to deliver the NaV1.7 mechanism, for potentially for ocular pain. And so there's really a platform here that we look to explore as we advance Halneuron's development. Okay. And you said interim data. So just the size and scope of that Phase IIb, that's all, that's being run in the States as well? Yes, we are repurposing the program to run it exclusively here in the States, and this is one of the things the expertise the team brings to this particular task, and that is we'd like to set up these recruitment networks around MSAs. So you get the Hem/Onc community all lined up to recruit patients into two or three specific pain expert sites, specific pain research sites, to accelerate the throughput of patients. The goal here overall, based on the effect size we've seen to date, is to target about 200 patients. We will commence recruitment in the program as we turn the calendar into 2025. We expect the interim data readout in the second half of next year. That unblinded or that blinded analysis that the external party will look at will give us clues into what the exact effect size is, and what the ultimate sample size needs to be, and that will inform future research, capital scaling activities, et cetera. So this Phase IIb is being halted wherever it is right now, and you're going to move it to the U.S., or you're just starting a new trial? We're basically closing down the old trial and starting up the new trial in early part of Q1 next year. So first patient, first visit, Q1, interim data readout second half of next year for the Halneuron program. Okay. So the, I guess the main takeaway for investors is that, well, obviously the drug has a novel mechanism of action- Mm-hmm ... pain space, could replace opioids, but the WEX group or CKLS had the drug, they have the indications they needed, then they have the financing they need, and the right team. I think it would be safe to say that we're bringing our management team to work with WEX, so the WEX team is nesting under the former legacy Virios Therapeutics executive team. Okay. The four members that was the executive committee members of Virios Therapeutics will be four of the executive committee members moving forward. We have the head of manufacturing will be part of the leadership team, but I think your summary is very correct, Jason. It's really their drug, their capital, and our team put together to deliver this asset to patients who greatly need new therapeutic options. These are four sub-Q injections or intramuscular? These are sub-Q injections. Got it ... usually into the abdomen. Uh- And it will be over the prior studies have been four-day period. We're exploring exactly what is the right dosage regimen, and we may actually move to a unique dosing formulation here that's a little bit longer and once a day, as opposed to four days twice a day. But that's to be discussed with the Food and Drug Administration. So, I wanna save time for IMC-2, right? Because that- Sure ... that's the near-term event. And maybe you can walk everybody through, and I still feel like people are just not as versed in, you know, what drives long COVID and fatigue-related illnesses, particularly from viral infections- Mm-hmm ... just in general, and where you are with your kind of Valtrex, celecoxib, IMC-2. Sure. Theoretically, there's been four or five hypotheses about what causes long COVID, and we believe from a Dogwood perspective, former Virios Therapeutics perspective, that the leading cause of this is actually reactivation of secondary viruses. We're all infected with, you know, many of these viruses. Some estimate we're all infected with several hundred thousand viruses as we sit here today. The most notable of those are the herpes viruses. If you think about something like chronic fatigue syndrome, what is now known over time, you know, or mononucleosis, is that the bad actor is reactivation of the Epstein-Barr virus. That's causing the fatigue that's associated with chronic fatigue or mononucleosis. If you have a teenager around, you've probably come in contact with this, if you haven't yourself. So that is a very good analogy, excuse me, to what we're attempting to do here, which is we believe when you stack the SARS virus, the COVID virus, on top of these other viruses, which by the way, are generally resident in your immune cells, you stress the immune system, and it's not the SARS virus that's causing the long COVID, it's the reactivation of these secondary viruses, which are leading to the long COVID sequelae. Why we think this is the right pathway is about a third of people who develop long COVID had no idea they had COVID in the first place. If long COVID was related to the SARS virus, they should have those symptoms from the minute they get infected with that virus. Most of these patients go on to develop long COVID four weeks or longer after their original acute infection. So we believe the hypothesis has legs, and it's the most relevant hypothesis from our perspective. We ran a matched control study with the Bateman Horne Center out of Utah. Dr. Cynthia Bateman is an expert in fatigue-related disorders. And because long COVID looks a lot like chronic fatigue, many of the people that were experts in chronic fatigue became experts on long COVID. And so we did a matched control study of 22 patients treated with valacyclovir and celecoxib, and we matched them age, gender, duration of illness, vaccination rates to a control group, and monitored those patients over the course of 12 weeks. And what we saw was highly statistically significant improvements in fatigue. In fact, in orthostatic hypotension, which is the second most debilitating effect, this is hypotension associated with getting up. If you've ever been dizzy when you got up quickly, this is what these patients go through on a day-to-day basis. So we saw highly statistically significant reductions, not just in fatigue, but also in orthostatic symptoms, hypotension, and improvement in activities. We also saw reductions in a host of other things, including pain and anxiety, which I think is probably more related to controlling the actual disease itself. And these are in patients who, on average, had long COVID for two years. So these are not people who just popped up and, "Yeah, I'm feeling some fatigue after five weeks." These are people who actually had long COVID for, on average, for two years, 80-plus% of the patients in the treatment group, and the match controls had been previously vaccinated, which by the way, hints again towards SARS-CoV-2 virus not being the bad actor here. So that study led us to a second study, which is now a placebo-controlled double-blind study run by the Bateman Horne Center through an investigator-initiated grant to assess two doses of valacyclovir and celecoxib versus placebo. Those data will be released sometime in the coming weeks, shortly this quarter, and we're very excited about that, particularly in the context of the point you made earlier, Jason, which is the U.S. government is now allocating dollars to assess long COVID and long COVID treatments. They have an application process for unique topics to consider to get access to those non-dilutive funds. We've applied, as you would well imagine- Right ... and are looking forward to using these data to support advancing the cause here for moving valacyclovir and celecoxib into a bigger treatment program as a treatment program. Also, there's other anecdotal evidence of... Actually, it's more hard evidence that you are on the right track. There's a drug that was approved ex-US for a company we work with, AIM Immunotec. It's Ampligen. Mm-hmm. It was approved for chronic fatigue syndrome. It's a synthetic double-stranded RNA. It just hits on the whole antiviral response, right? So there's- Mm-hmm ... there's that, and they've had some success in long COVID, but they've moved on to a lot of oncology work, right? But then, and Paxlovid, Pfizer's drug, failed. Yes. I think that's the biggest thing, that is not overlooked. I think people are just unaware because they don't broadcast it. But Paxlovid missed in long COVID, like, big. It wasn't even close, right? That's exactly right, and I think further supports, which is where you're going, Jason, that it's likely not the SARS virus that's the bad actor here. Mm-hmm. We really think it's these secondary viruses. And by the way, success here, we believe, because we've agreed with FDA that fatigue, I believe, for the first time in their history, fatigue would serve as our primary endpoint. Fatigue is a symptom that's responded in both the fibro trials and in the long COVID trials, and we believe with success here, we open up other areas of research, including chronic fatigue, fatigue associated with multiple sclerosis. So this is really the thin end of the wedge, if you will. With success here, we think there's other places this regimen can have great utility for patients. Will orthostatic intolerance work its way into the next trial as well? Or FDA actually allowing you to use fatigue is a big deal. Yeah. Yep. So fatigue will be the primary. Orthostatic intolerance, it was interesting, we submitted the data, and they were very intrigued by this because they said, "You know, this is a symptom that we keep hearing about, is very problematic for these patients." It's not intuitive. Why would you have dizziness or hypotension when you get up? And there's obviously, clearly something structurally going on here. But effectively, they said, "We also will assess orthostatic intolerance as a key secondary." And that moved... That we moved the needle very significantly on both of those endpoints in the prior trial, and hope that's gonna be the case in the data we release in the coming weeks. Right, and yeah, right, that Bateman Horne data is due soon. And this is a quick talk, right? Till we're almost out of time. Just, but quickly- Yeah. Just if you wanna run through the upcoming events for the company. Sure ... for investors, and also what that, once this everything gets closed, what the market cap of this company's going to be on the at Dogwood, right? It's not Virios was at, like, five, but this is gonna be obviously much higher than that. Yeah, well, the market's responded quite well- Mm ... post our announcement over the last couple weeks, so we hope that continues as people see the value in the addition of the Halneuron asset. And by the way, one of the nice things about this strategic financing, Jason, is it gives us operational runway through the end of next year. That doesn't just facilitate execution of the Halneuron Phase IIb trial, it gives us time to engage with the U.S. government, time to continue to secure some form of partnership for IMC-1 for fibromyalgia without having to raise additional capital, right? So we would've had to raise capital to just give us the runway to execute those discussions. So key milestones coming up, quarter four will be the long COVID data, the IMC-2 long COVID data. We're very excited about that. Quarter one will be first patient, first visit in the Halneuron Phase IIb trial. We will do an update on IMC-1 partnership end of quarter one, beginning quarter two, and we'll have the interim readout for the Halneuron data sometime in the second half of next year. So we think three very significant milestones for the three assets we're progressing for pain and fatigue-related disorders. Capital to go not to, but through all of those events, something that we're always looking for in biotech. It's been challenging, but leaves Dogwood in a good place over the next 12 months. That's great. Yeah, we've got capital to get through the end of next year, and if you think about the structure of this deal, and I think this is resonant in the market's response to this, companies our size cannot raise the type of capital, generally speaking, that we just raised, to execute this program and our operations through the end of next year. So we're very excited about that, bringing a stable institutional shareholder to the shareholder base, we think is good for Virios Therapeutics as we balance out the institutional and retail shareholder base. And, you know, I think with good data, we have a pretty good opportunity to have CKLS serve as an anchor for a future financing to execute the second half of the trial, and potentially IMC-1 and IMC-2 activities as well. Great. Thank you, Greg. Out of time, but, we'll catch up again soon. Hope to have you back. Thank you, Jason. Really appreciate it.