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Thank you very much, Angela and good morning all. As Angela referenced last month, we announced the formation of dogwood therapeutics by the integration of verys therapeutics and wex pharmaceuticals given the proximity of this transformative transaction. We think today's earnings update represents an opportune time to share our thoughts on the key value creation opportunities that now reside within the expanded Doug with therapeutics pipeline, Mike. And I provide you with highlights on our three late stage program with a particular focus on the newest addition to this pipeline hal neuron, our NAV 1.7 modulator that will be the focus of the forthcoming chemotherapy induced neuropathic pain phase two program. We expect to commence in quarter one of next year, Mike and I will be making forward-looking statements through the course of our discussion today. We'll have a Q&A at the end of our overview. And if you have additional queries post today's call, you can reach out to us directly at IR at DWTX dotcom.
Before diving into the specific programs, I thought I might just summarize or refresh the highlights of the transaction to form Dogwood Therapeutics.
Your main to this formation was an expansion of our pipeline to include hal neuron currently projected to have interim data in the phase two B program for chemotherapy induced neuropathic pain in the second half of next year, as Angela referenced the strategic financing by an affiliate of Life Sciences, a hong Kong exchange listed company and existing cash provides us with working capital of approximately $23 million to fund operations to quarter four of next year. Importantly, this enables us to deliver interim results from the phase two B program focused on how neuron in this time period. Additionally, IMC two, a combination of ALSIC and SOIC is the focus of a phase two, a study run by the Bateman Horn Center and we have data expected in the middle of this month as part of the transaction. Our stockholders as of record of October 17th were granted a contingent value right or CV R as you may know it tied to potential future milestone payments associated with future partnering transactions for I MC, one or I MC two, particularly related to development or regulatory milestones.
And this team, the combined team of Rio therapeutics and WEX pharmaceuticals that is now the dog with therapeutics. Management team has extensive experience in developing and commercializing several blockbuster drugs, including the pain medicines, CeleBREX, Lyrica, and SA as you can see on slide number four, in addition to Angela Mike and myself, we'll be presenting today. We have Ralph Crossword, who's our senior Vice President of Operations and M Joe, our VP of manufacturing. You can see the companies, the team has worked at have extensive training and experience. And you can see on the right hand side of slide number four, a number of drugs that we've been involved in including pain therapeutics. And so we we are really excited about the potential of hell neuron and the life cycle opportunities in this new addition to our portfolio.
Speaking of our portfolio, as you can see a rate on slide 5, we now have the expanded Doug with therapeutics pipeline which targets several areas of unmet medical need and has in our opinion, very significant value creation potential. There are really two pillars to the pipeline. First is the nav 1.7 platform. The focus of which is how neuron and specifically our phase two B program and chemo induced neuropathic pain.
I will mention we're excited about data, some data that Mike will share with you in the next few moments and how no one's potential to treat broader cancer related pain. We also believe this mechanism has potential in acute pain and recently filed intellectual property protection for unique contact lens formulation, delivery formulation of the NAV 1.7 therapeutic. So, really a potential for this platform to deliver in many different areas among that need. The second pillar of the portfolio is our combination anti viral program featuring I MC one, the combination of Baam, CYCL and BCCL and the Long COVID or past program, which features I MC two, which is a combination of bowel cyclo and Celecox I MC. One is poised to progress into phase three development. And as I mentioned earlier, and we'll speak more about this later in the course of today's presentation, we expect a long COVID phase two A results in the middle of this month. So with that background, let me turn it over to doctor general to talk a little bit about the mechanism of the NAV 1.7 platform. And some of the data that has us really excited about how neurons potential Mike.

Thanks Greg. So going to first present the newest addition to our development, stable hail neuron. Ha neuron is a voltage gated sodium channel modulator. Sodium channel are integral to how neurons propagate electrical signals through the through them to the spinal cord and ultimately to the brain. And the particular NAV 1.7 channel, which hell neuron is specifically targeted for is very involved with peripheral pain. So there's nine known sodium channels, some of which are more involved with cardiac conduction and other parts of the body. But the NAV 1.71 0.8 and 1.9 are those that are most associated with pain and inflammation. So, hell neuron being a 1.7 modulator has the ability to really change how pain is transmitted in the body. And we think it has potential for both chronic and acute pain as we've talked about.
So let's go to the next slide and we'll talk about the opportunities for what we think the applications for hell neuron would be. The prior work that was done by the predecessor company focused on two different areas. There was a phase two study looking at cancer related pain that is they took people who were having, you know, had cancer, had pain from that cancer and then treated them with injections of hell neuron to try and reduce the pain that they were experiencing subsequent to their cancer, their surgery or the chemotherapy, whatever the cause of that pain was.
And that study generated statistically significant reductions in pain in a, in a study that had enrolled 165 patients. That was encouraging to us and we were specifically encouraged by the duration of the improvement we saw in some of those patients, which we'll talk about in a minute. The other study that was done prior to our combination was a phase two, a signal seeking study in chemotherapy induced neuropathic pain. So that is the indication our next study will be focused on and what was done there. It was 125 patients were recruited and they were randomized to one of three different doses and two different dosing strategies either once a day or twice a day to determine what the optimal dose and dosing frequency would be to carry forward in a future study. And that future study is the one we're planning right now. So given that that background, we were very excited about the potential for hell neuron in treating pain, secondary to chronic conditions like cancer related pain, that slide.
So this is data from that cancer related pain. I mentioned where we had statistically significant results in terms of pain reduction due to hell neuron. This is a responder analysis where we looked at patients who had at least a 30% reduction in pain from their baseline before they were treated with he neuron. And what we saw was that there was a statistically significant increase in the rate of response in the patients treated with hail neuron versus those treated with placebo. Even though this was a relatively small study with less than 160 some odd patients. It was still statistically significant in terms of this responder analysis after three weeks of treatment.
What was even more interesting in this, however, was the duration of response we saw from this treatment which we'll talk about in a minute. Looks like this shows now the duration of response and the curve on the top where you can see these blue lines, this was the patients who were initial responders. That is at week three of the study, they had at least a 30% reduction in pain from their baseline. If they were a responder, they were continued to be followed on a weekly basis to see how long that pain improvement lasted. And if they if they continue to be followed, you can see that there were a number of patients who went out quite a long way, some went over a year in terms of pain reduction. The bottom curve are those responders to placebo. You do get patients who reach improve on placebo. But you can see here, the main improvement in those who were initial responders was on the order of 10 days that before they lost their effect, the main change in the hell neuron group was over 50 days and in some cases, it was beyond a year before the patient finally got tired of giving us data. But you can see there's a very big difference between the duration of the improvement we see with treatment versus placebo. And that, that really intrigued us and made us think that something special is going here because they were only treated for four days initially. And then we have this long response as a result.
Let's go to the next slide, please.
So I think Greg we're going to hand that back to you to talk about the potential.

Sure, Mike referenced the second study, the chemo induced neuropathic pain phase two, a study, the signal seeking study which assessed three doses and two different dosage regimens of hell neuron to treat specifically cinp.
The results of this study are a rate on the left hand side of slide number 10, very specifically higher hell neuron doses deliver greater pain reduction as compared to lower doses, which we think is very consistent with the utility of this particular mechanism.
We also noted that he neuron when dosed once a day. QD provided comparable pain reduction to the B ID dose twice a day but exhibited a better tolerability profile.
How neuron pain relief was evident four weeks, post treatment in this particular study and the hell neuron high doses in particular, delivered clinically meaningful pain reduction for 35 to 40% of patients in this relatively small study.
AC A MP we believe represents a very significant market opportunity. Presently, there are no FDA approved treatments for chemo induced neuro neuropathic pain.
We know from our secondary market research data that more than half of the sales for the global pain market are actually prescribed for opioids.
I don't think I have to tell anybody on the phone here that that's a bad fact for any particular disease, given the abuse potential and the side effects that are associated with opioids. I think we'd all probably agree as well. If we have something that can work to replace or reduce the utilization of opioids, we have something that's commercially speaking a winner.
Over time, most patients get some form of neuropathic pain. If you look at the background data for chemo induced neuropathic pain, one month after treatment, there's about 70% of patients who have some form of neuropathic pain. Three months that drops down to 60% but even at six months, you have 30% of patients in neuropathic pain. This is six months after the discontinuation of the chemotherapy. This is a bad fact. And in fact, if you look at just the big five markets in the Eu Japan and the US, there are 1.7 million induced neuropathic pain patients in just those territories. When you add in developing markets and other potential markets across Europe, you have well north of $2.5 million patients that are actually suffering from chemo AUC. So the size of the opportunity, the heavy utilization of opioids and the fact that this is impacting one in three patients who have chemotherapy six months after they stop their chemotherapy represents in our opinion, a very significant commercial opportunity.
So to summarize the hell Neuron program, which we think represents a very novel non opioid pain development opportunity. This is a novel 1.7 voltage gated sodium channel inhibitor, highly differentiated from other therapeutics and specifically non opioid in its particular mechanism.
This is a validated mechanism supported by both pre clinical and clinical data.
We've seen Mike and I just share with you reduction in both general cancer related pain and chemo induced neuropathic pain in human clinical trials. This is a large market opportunity and this is a team that understands the pain stays well both from a development and a commercialization potential.
So we are really excited to add Helmo run to the deal with therapeutics pipeline. And we're very excited about the interim analysis. We plan for the second half next year.
Now we turn our attention to the legacy various therapeutics products. The combination antiviral therapies, which we believe are targeting two very significant areas of IMC. One is poised to progress into phase three development as a treatment for fibromyalgia, a condition for which there has been nothing approved for the past few years. In fact, well, over a decade, we have agreement with FDA based on our phase two B study for a four part phase three program, that program will consist of a pharmacokinetic and food effect study with a new formulation would progress into phase three development for fibromyalgia.
Two direct studies of 12 weeks duration, one head to head study of I MC one versus placebo and then a multifactorial trial of I MC one versus placebo versus the individual components that comprise I MC. One is a combination there, patients who have an interest can progress from study. One or study two into our long term safety extension which allows us to collect the safety data required to submit an NDA to the Food and Drug Administration.
We're presently exploring phase three partnership opportunities both to conduct the study as well as to develop an extended release dosage formulation to extend the IP of I MC one beyond its current intellectual property protection, we'll report out on that sometime in the first half of next year. And then we have I MC two, the combination of Valico and SOIC coin the focus of a phase two long COVID study.
We had a proof of concept study complete in 2023 Michael share the data with you that have us excited about this particular mechanism that study allowed us to file new IP with patent protection if granted to 2044. Importantly, this study gave us the data to go to FDA and work out what the development requirements are for I MC two to treat non COVID symptoms. And in particular, we've now agreed with FDA that for the first time to our belief is the first time FDA is approved, fatigue is the primary endpoint for a development candidate. There's a three arm phase two investigator initiated study ongoing right now, topline data which we expect in the middle and with that background on the two programs, I'm going to ask Mike to dive into the data from the proof of concept study. We communicated out in 2023 as a refresher as we get excited about the release of the current study in the next week or so.
Right.

Sure, great. So we, we did have a proof of concept study previously run by the Bateman Horn Center. This was an investigator initiated study where they were the first question was, was there any feasibility to show with applying this an viral approach to a long COVID patient population? The Bateman Horn Center has a long COVID clinic where they had a number of patients. They were, they were monitoring and taking care of and when they initiated this study, they recruited from that long COVID population and they enrolled 22 patients to be treated with the combination of the al Cyclos COXY to treat their lung COVID symptoms. This step conducted open label. So these 22 patients were aware they were getting the antiviral treatment and they were, the results were compared to 17 match controls drawn from the same population and they were matched for their gender for their age for how long they've had long COVID, whether they've been vaccinated and so on. So they were well matched group. And then the comparison was reduction in symptoms of long COVID in the treated population versus the mass control population. It's interesting to note that the duration of long COVID symptoms in this population was over two years in both groups. So this is a group of patients that had long standing lung COVID had been difficult to treat with other therapies and then treated with this antiviral combination to see if we could really improve their symptoms. And as you can see on the slide with the study endpoints, there was fairly dramatic improvement in a number of symptoms in this patient population. The primary endpoint was fatigue improvement. We see that this long COVID population looks quite a bit like chronic fatigue populations. And the ba and Harm Center is a specialty center in treating fatigue and pain conditions. They were very interested in fatigue in this population. And the NH promise fatigue score was used as primary. And again, you can see even though this is 22 patients compared to 17, it was highly statistically significant in favor of the antiviral treatment. Fatigue was also measured on a 0 to 10 numeric rating scale. The standard scale we've improved on that as well. We saw some movement in pain. We asked a patient global impression of change question two different ways to ask the patient since they enrolled in the study, how they were doing. And in both cases, the patients reported significant improvement in the quality of life.
We also had a an assessment of orthostatic intolerance. This is the feeling that patients get when their autonomic nervous system doesn't respond quite properly. So when you go from sitting to standing or lying down to sitting, you might feel faint, you might feel like you're going to black out. That's orthostatic intolerance. It's common in the long COVID population. And we saw a significant movement on the orthostatic scales in this study as well. That was something the Bateman Horn Center was specifically interested in. It was new to Dogwood, but we were quite pleased with the results that we saw on this orthostatic scale and we even saw some movement in in mood disorders probably because patients were feeling that their symptoms overall were improving.
Now, as I said, this was an open label study. The treatment was very well tolerated. We know that val cyclo VR has very little interaction with mammalian cells. So it's very well tolerated. Celecoxib is the best tolerated of the nonsteroidal anti inflammatories. So real, it was not a surprise that it was well tolerated with seeing that before with the other antivirals. But nonetheless, it really suggest that this could be a first line treatment If it continues to do well, being open label, we wanted to confirm this in a more classic double blind placebo controlled study. So we did approach Ba and Horn Center about doing a follow up study, which would be the placebo controlled double blind study and so on. So that study has been run at the BX.
They've enrolled 45 patients that they randomized three arms 1 to 1 to 1 a high doses, the antiviral combination, low dose antiviral combination and a placebo arm that result is still blinded. We will be getting the results shortly. But we're looking forward to seeing if we can reply the results we saw in the proof of concept study. Primary end point again is fatigue reduction. We'll be looking for improvement in sleep orthostatic symptoms, anxiety, depression, and overall health when we get the results from this study. And as we've already mentioned, the top line results are expected in the next few weeks. So with that, that's a, that's our antiviral platform and where we stand on that, I'll turn it back to Greg to wrap up.

Sure. Just one word about long COVID and the opportunity. They are pretty clear that this is a major global event. Estimates from CDC suggest that long COVID'S impacted around 400 million individuals across the globe and has an annual economic impact of approximately $1 trillion. That's equivalent to about 1% of the global economy.
Why is that? Well, there's a higher incidence in adults 18 to 64 as compared with 65 plus. If we think about acute COVID, the primary issue, there is the elderly when it comes to Long COVID. And what we believe is the reactivation of secondary viruses. It's actually more present prevalent in the working population. Hence the economic impact associated with this particular illness in the US. We estimate that 6.5% of the non institutionalized us adult population has experienced long COVID since the introduction of COVID back in 2019 or 2020.
As you're probably aware, there's nothing approved to treat long COVID by the food and drug administration. And to date therapeutic research has exhibited very little progress. Notably pfizer's palod, which people have high hopes for failed in its one long COVID trial. We think that's rational because we don't think long COVID is associated with the SARS virus, which is the focus of palod. We believe it's the reactivation of secondary herpes viruses which are delivering the Symp and the sequeli that are associated with LCO.
The bat results are shortly forthcoming and we believe one of the unique benefits of the formation of Dogwood is that enables us ample time to consider the value enhancing development pathways that sit before us both traditional financing and non diluted funding options to advance I MC two into phase two to phase two B development for the treatment of long COVID illness.
And really just to summarize on our next updates, we believe this pipeline has very significant value creation potential. The long COVID data are due in the middle of this month. We're very excited to report that out in the next week or so. The fibromyalgia program I MC one is poised to progress into phase three and we'll do an update on partnership in the first half of next year. And as Mike went through very nicely, we have the phase to be interim data from the hell neuron C I MP program due in the second half of next year with that background to the program. Let me open it up to questions. So back to you as our operator.

Question and Answer Session

Operator

Thank you. At this time, we'll be conducting our question and answer session.
If you would like to ask a question, please press star one on your telephone keypad.
The confirmation tone will indicate your line is in the question queue and you may press star two. If you would like to remove your question from the queue for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment please. While we pull for questions.
Thank you. Our first question is coming from Jason mccarthy with Maxim group. Your line is live.

Hi guys. Thanks for taking the questions. Greg, maybe you guys could talk a little bit about the how neuron a little bit more rather durability of response when patients stopped taking drugs, you know, was how far out did that go? Kind of what do you? And is there a dose response high versus low that's associated with that? And what do you hypothesize might be the reason for it?

Well, Jason, thank you for joining today and I'm going to turn the question over to Doctor General who's best placed to answer that question for you?

Sure, Jason. So in terms of durability of response. The study that was conducted that had durability information was that cancer related pain study, we showed the median response time or the actually average response time was 57 days for the hell neuron group and 10.5 days for the placebo group among responders. So if they were initial responders in three weeks, they were followed to see how long that response lasted.
No, that's due to that's from a single cycle of four, you know, four days of injections twice a day for four days.
We don't, we will not necessarily plan in long term to only use this for four days. This is if it's an analgesic, it can be repeated. And one of the questions we will be looking at as we progress development is how often should this treatment be repeated? How many injec injections do you need subsequently and so on. So, we, we see hints of durability well beyond four days and whether it needs to be a week, two weeks, four weeks, eight weeks, how long it needs to last before we repeat is one of the questions we'll be looking at in terms of your question about dose response in the chemotherapy induced neuropathic pain study. Three doses were looked at there was a quite low dose and mid dose and high dose. The results were best with the high dose. So we did see a dose response both in terms of efficacy and adverse events. And that result has led us to go with that high dose, which is what we're taking forward into the two B study that's being planned right now.

Yeah, Jason, I, all I would add is we do think there may be something structurally or some kind of reset going on with the nerve transmission. And that is something we're exploring right now to see if we can't tease that out through forward research. But it is pretty clear, this effect is doing something that's providing a very durable effect.
And hopefully, we can find out a way to show that through either pre clinical work, animal work or human clinical trials. And we'll endeavor to do so.

And just in terms of the state profile, I think I caught it earlier from the B ID to the QD.
It was a better tolerability profile and I know they're unrelated mechanisms between opioids and neuron. But are any of those tolerability issues related to respiration?

We did not see a respiratory adverse event signal in these studies. So the doses we're using quite low doses. So the doses we're employing are not, do not appear to be sufficient to cause major respiratory suppression as you would get with a very high dose. The in terms of going from twice a day to once a day, we did see a better tolerability profile with once a day and we didn't see any meaningful change in efficacy with once a day dosing versus twice. So it became a pretty obvious choice to go with once a day dosing.

And just last question quick as part of, oh, sorry guys.

No, not at all. I was just, I was going to just add to my comments that one of the things that was attractive to us about home. There is a specific focus on the 1.7 modulator as opposed to other targets, there are n target spread throughout the body. As Mike said 171,819 are primarily focused on pain signaling. And so that actually pull through when you take a look at the tolerability data, I didn't mean to cut off the follow up question.

Got it last last question really quick. You had mentioned that 50% or so of T I patients do use opioids because there is nothing else that FDA asked or do you think they'll ask for any information coming out of your trial on any reduction in the scripts or opioids or maybe opioid based rescue for any patients that might be having more severe pain.

They will be interested to see if you have a reduction in rescue with treated patients versus control patients. We, we don't at this point plan to pursue a opioid sparing claim. And if you don't pursue a sparing claim, then they're not going to insist you show a reduction in usage. That's a very complicated issue to chase because the reasons people change opioid doses are, are complicated. It's not just your treatment. And it's from a clinical trial standpoint, it's better to try and keep all the ancillary treatment, medications constant throughout your, your study. This is going going to be a four week study. So we're going to try and keep, if they're on opioids, we're going to keep those constant as much as we can. If they need rescue, we're going to use a, a different rescue than a straight opioid. So we're going to try and not have opioid be a major variable in interpreting the results we get once we treat patients with H&M.

Got it. Thank you guys.

Thank you, Jason. We appreciate you joining this morning.

Operator

Thank you. Our next question is coming from Dave Bouts with Zacks small Cap research. Your line is life.

Hey, good morning, everyone. I was wondering if you could provide a few details on this, the phase two B trial for how neuron And if you can provide in that regard and then what are the steps that you need to go through if any before that trial can get going underway?

David. Good morning. This is Greg. Thank you for attending this morning. I'll turn it over to Mike who's spearheading not just the clinical piece of this, but the regulatory piece as well to talk through a little bit about the process we're undertaking before we start dosing patients in quarter one, which is our goal.

Sure. So, you know, hell no. And has been used in Cinp before and that dose ranging proof of concept study I mentioned we're going to use that as a background. The study we're designing the two B study we're designing is significantly larger. We are using the, the high dose dose once a day. So it's a somewhat different design than we've used before. But it's actually consistent with what the FDA has seen before. And we think going to once a day dosing actually will be attractive in terms of, since we, we see better tolerability once a day versus twice a day. Arguably we're going to go in with a trial design that FDA is going to think is, you know, better tolerated, potentially safer in terms of the study itself. It's a four week long study. We will be dosing. We'll be given the same eight doses that's been used historically, in the past, it was four days of twice a day dosing. We're going to go to once a day dosing for eight days. It'll be spread over up to two weeks. So the same amount of total drug delivery will happen just in a different dosing format. We will primary end point will be a week four at which point, patients will exit the study. It'll be 1 to 1 randomization against placebo of traditional design with an interim analysis. As we have talked about scheduled for the second half of 2025 we anticipate we'll have roughly 40 to 50% of our targeted enrollment in the patient for in the study for that interim analysis. Again, the primary endpoint is going to be reduction in pain over time. We'll be looking at what fraction of patients have significant improvement and how long it lasts within the context of the four week study. That that's to set us up for a phase three program where we, we already have some agreements with FDA about what a phase three would look like in this indication. But this is our really proof of concept to do proper power calculations and get a handle on what it would take to, to get this through the approval process.

I should mention Dave as we do with all this stuff that's obviously subject to FDA input. But I think there's a very good logical flow for the transition to this particular study and very high hopes for Helmo is a really important new treatment.

Okay, great. Appreciate the details there. And lastly what are if any, the conditions that need to be met to get that second tranche of money in February of 2025.

There are really no material obligations to meet, to get that that money in quarter one to make sure the intention is certainly to do so. As long as we maintain a good, consistent listing standards and all those other things that are required as a public entity, we don't see any, any impede impediments, excuse me, to getting the additional $3 million.
Okay. Ultimately taking, yeah. So PLS is very excited about this program. I don't think it's too much to say that having a very good stable institutional shareholder strategic in its own right, as one of our large and soon to be our largest shareholder is anything but a good fact. And so they're very committed to the asset and look forward to moving that asset forward.

All right, great. Thanks for taking the questions.

Thank you, David.

Operator

Thank you as we have no further questions in queue at this time, I'd like to turn it back over to Mr Duncan for any closing remarks.

Yeah. First off, thank you for those of you who joined this morning. Hopefully, you can tell we believe the formation of dog with therapeutics last month represents a very transformational event for us. And in particular, the expansion of our pipeline to include how neuron as a complement to I MC one and I MC two.
The concurrent strategic financing by CKLS is affiliate, the former owner of Wex Pharmaceutical provides us with this nice tranche of operating capital to get through the end of next year inclusive of the readout for the hel neuron phase to be studied the interim readout specifically, it is our view that this is a win win for Legacy Bureau shareholders and CKLS shareholders with both short term and medium term potential value creation opportunities associated with the forthcoming long COVID phase two data for I MC two and the phase two B data next year. For Hell Neuron, we look forward to updating you on all of our progress in a very timely manner starting with sharing results from our recently completed BHC long COVID phase two study in the next week or so. We want to thank you for your time and attention today.

Operator

Thank you, ladies and gentlemen, this concludes today's conference and you may disconnect your lines at this time and we thank you for your participation.