Dogwood Therapeutics Q3 2024 Earnings Call Transcript

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November 7, 2024

There are 6 speakers on the call.

Operator

Good morning, and welcome to the Dogwood Therapeutics Incorporated Third Quarter 2024 Earnings Call. At this time, all participants have been placed on a listen only mode. Please be advised that today's call is being recorded at the company's request. At this time, I'd like to turn the call over to Angela Walsh, Chief Financial Officer for Dogwood Therapeutics. Please proceed, Ms.

Operator

Walsh.

Speaker 1

Good morning, everyone, and thank you for joining us on today's conference call. We are pleased to be with you today to discuss Dogwood Therapeutics' 3rd quarter financial results and to provide a corporate update. Please note that our financial results press release is now available on our website. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially from the information expressed or implied by these forward looking statements. For more information regarding such risks and uncertainties, please see the risk factors outlined in the company's filings with the SEC.

Speaker 1

Any forward looking statements are made only as of today, and we disclaim any obligation to update these forward looking statements other than as required by law. For today's agenda, I will provide a brief financial update and then turn the call over to our CEO, Greg Duncan and Chief Medical Officer, Doctor. Mike Genro, to provide our corporate summary and highlights related to our recently announced business combination, which formed Dogwood Therapeutics. Our financial results for the Q3 2024 were published this morning in our press release and are available on our website. Therefore, I will just provide a brief summary of our financial status on today's call.

Speaker 1

As of September 30, 2024, Dogwood Therapeutics cash totaled $2,000,000 On October 7, 2024, we announced a business combination with Pharmagesic Holding Incorporated, the parent company of Wex Pharmaceuticals Incorporated to form Dogway Therapeutics. A key component of the combination was a concurrent $19,500,000 strategic financing by an affiliate of CKLS, CK Life Sciences International Holdings Incorporated, a Hong Kong Exchange listed company and an indirect parent company of Pharmagesic and Lux Pharmaceuticals. We have received $16,500,000 in loan proceeds in connection with this financing, with an additional $3,000,000 expected to be received in February 2025, resulting in approximately $23,000,000 in working capital, including combined cash of the entities at the time of the combination. Based on our projections, this should fund research and operations through 2025 and through several key milestones, including the announcement of top line results from the long COVID Phase 2a study expected in the middle of this month and the release of results from the how Neuron Phase 2b interim analysis assessment expected in the second half of twenty twenty five. We expect to file the Form 8 ksA with the combined entity's financial statements in mid December of this year and look forward to keeping you updated on our progress.

Speaker 1

Now, it is my pleasure to turn the call over to our CEO, Greg Duncan to provide our corporate summary. Greg?

Speaker 2

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 Vireos 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 Dogwood Therapeutics pipeline. Mike and I will provide you with highlights on our 3 late stage program with a particular focus on the newest addition to this pipeline, HalNeuroc, our NAV1.7 modulator that will be the focus of the forthcoming chemotherapy induced neuropathic pain Phase 2 program we expect to commence in quarter 1 of next year. Mike and I will be making forward looking statements through the course of our discussion today.

Speaker 2

We'll have a Q and 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 irdwtx.com. Before diving into these specific programs, I thought I might just summarize or refresh the highlights of the transaction to form Dialogood Therapeutics. Germane to this formation was an expansion of our pipeline to include HalNeuroc, currently projected to have interim data in the Phase 2b program for chemotherapy induced neuropathic pain in the second half of next year. As Angela referenced, the strategic financing by an affiliate of CK Life Sciences, a Hong Kong Exchange listed company, and existing cash provides us with working capital of approximately $23,000,000 to fund operations to quarter 4 of next year.

Speaker 2

Importantly, this enables us to deliver interim results from the Phase 2b program focused on Halmauron in this time period. Additionally, IMC2, a combination of valsiclovir and celecoxib is the focus of a Phase 2a study run by the Bateman Horne Center and we have data expected in the middle of this month. As part of the transaction, our Vireo stockholders as of record of October 17th were granted a contingent value right or CVR as you may know it, tied to potential future milestone payments associated with future partnering transactions for IMC1 or IMC2, particularly related to development or regulatory milestones. And this team, the combined team of Vrio Therapeutics and WEX Pharmaceuticals, that is now the Dogwood Therapeutics management team has extensive experience in developing and commercializing several blockbuster drugs, including the pain medicines Celebrex, Lyrica and SEDALA. As you can see on Slide number 4, in addition to Angela, Mike and myself, who will be presenting today, we have Ralph Grosswald, who is our Senior Vice President of Operations and Meng Zhou, our VP of Manufacturing.

Speaker 2

You can see the companies the team has worked at and have extensive training and experience. And you can see on the right hand side of Slide number 4, a number of drugs that we've been involved in, including pain therapeutics. And so we are really excited about the potential of Halneuron and the lifecycle 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 Dogwood Therapeutics pipeline, which targets several areas of unmet medical need and has, in our opinion, very significant value creation potential. There are really 2 pillars to the pipeline.

Speaker 2

First is the NAV1.7 platform, the focus of which is Hal Neuron and specifically our Phase 2b program in chemo induced neuropathic pain. I will mention we are excited about data, some data that Mike will share with you in the next few moments and Hal Neuron'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 NAV1.7 therapeutic. So really potential for this platform to deliver in many different areas of unmet need. The second pillar of the portfolio is our combination antiviral program featuring IMC1, the combination of bamcyclovir and valsiclovir and the long COVID or PASC program, which features IMC2, which is a combination of valsiclovir and selacoxid.

Speaker 2

IMC1 is poised to progress into Phase 3 development. And as I mentioned earlier, and we'll speak more about this later in the course of today's presentation, we expect long COVID Phase 2a results in the middle of this month. So with that background, let me turn it over to Doctor. Genro to talk a little bit about the mechanism of the NAV1.7 platform and some of the data that has us really excited about TelNeuron's potential. Mike?

Speaker 2

Thanks, Greg. So I'm

Speaker 3

going to first present the newest addition to our development stable, Halneuron. Halneuron is a voltage gated sodium channel modulator. Sodium channels are integral to how neurons propagate electrical signals through them to the spinal cord and ultimately to the brain. And the particular NAV1.7 channel, which Helen Neuron is specifically targeted for, is very involved with peripheral pain. So there's 9 known sodium channels, some of which are more involved with cardiac conduction and other parts of the body.

Speaker 3

But the NAV1.71.81.9s are those that are most associated with pain and inflammation. So HelNeura 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 Helneuron would be. The prior work that was done by the predecessor company focused on 2 different areas.

Speaker 3

There was a Phase 2 study looking at cancer related pain. That is they took people who were having had cancer, had pain from that cancer and then treated them with injections of Halneuron to try and reduce the pain that they were experiencing subsequent to their cancer, their surgery or their chemotherapy, whatever the cause of that pain was. And that study generated statistically significant reductions in pain 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 2a signal seeking study in chemotherapy induced neuropathic pain.

Speaker 3

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 1 of 3 different doses and 2 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 background, we were very excited about the potential for Halineura in treating pain secondary to chronic conditions like cancer related pain. Next slide.

Speaker 3

So this is data from that cancer related pain I mentioned where we had statistically significant results in terms of pain reduction due to Halneuron. 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 HalNeuron. And what we saw was that there was a statistically significant increase in the rate of response in the patients treated with Halineurin 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 3 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.

Speaker 3

Next slide. This shows now the duration of response in the curve on the top where you can see these blue lines. This was the patients who were initial responders that is at week 3 of the study, they had at least a 30% reduction obtained 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 as 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.

Speaker 3

The bottom curve are those responders to placebo. You do get patients who improve on placebo, but you can see here the mean improvement in those who were initial responders was on the order of 10 days that before they lost their effect. The mean change in the Hal Neuren 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 improvement we see with treatment versus placebo. And that really intrigued us and made us think that something special is going here because they were only treated for 4 days initially and then we have this long response as a result.

Speaker 3

Let's go to the next slide, please. I think, Greg, we're going to hand it back to you

Speaker 2

to talk about the potential. Sure. Mike referenced the second study, the chemo induced neuropathic pain Phase 2a study, the signal seeking study, which assessed 3 doses and 2 different dosage regimens of Halneuron to treat specifically CINP. The results of this study are read on the left hand side of Slide 10, very specifically. Higher Hal neuron doses delivered greater pain reduction as compared to lower doses, which we think is very consistent with the utility of this particular mechanism.

Speaker 2

We also noted that Hal neuron when dosed once a day, QD, provided comparable pain reduction to the BID dose twice a day, but exhibited a better tolerability profile. Hal Neuron pain relief was evident 4 weeks post treatment in this particular study And the Hal Neuron high doses in particular delivered clinically meaningful pain reduction for 35% to 40% of patients in this relatively small study. A CAIP, we believe, represents a very significant market opportunity. Presently, there are no FDA approved treatments for chemo induced 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.

Speaker 2

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. You look at the background data for chemo induced neuropathic pain, 1 month after treatment, there's about 70% of patients who have some form of neuropathic pain. 3 months that drops down to 60%.

Speaker 2

But even at 6 months, you have 30% of patients exhibiting neuropathic pain. This is 6 months after the discontinuation of their chemotherapy. This is a bad fact. And in fact, if you look at just the big five markets in the EU, Japan and the U. S, there are 1,700,000 chemo induced neuropathic pain patients in just those territories.

Speaker 2

When you add in developing markets and other potential markets across Europe, you have well north of 2,500,000 patients that are actually suffering from chemoides neuropathic pain. So the size of the opportunity, the heavy utilization of opioids and the fact that this is impacting 1 in 3 patients who have chemotherapy 6 months after they stop their chemotherapy represents, in our opinion, a very significant commercial opportunity. So to summarize the helm 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 penning therapeutics and specifically non opioid in its particular mechanism. This is a validated mechanism supported by both preclinical and clinical data. We've seen, as Mike and I have just shared with you, reduction in both general cancer related pain and chemo induced neuropathic pain in human clinical trials.

Speaker 2

This is a large market opportunity and this is a team that understands the pain space well both from a development and a commercialization potential. So we are really excited to add helenoron to the Dogwood Therapeutics pipeline and are very excited about the interim analysis we plan for the second half of next year. Now we turn our attention to the legacy Vireos Therapeutics products, the combination antiviral therapies, which we believe are targeting 2 very significant areas of unmet medical need. IMC1 is poised to progress into Phase 3 development as a treatment for fibromyalgia, a condition for which has been nothing approved for the past few years, in fact, well over a decade. We have agreement with FDA based on our Phase 2b study for a 4 part Phase 3 program.

Speaker 2

That program will consist of a pharmacokinetic and food effect study with a new formulation with progress into Phase 3 development of fibromyalgia, 2 direct studies of 12 weeks duration, one head to head study of IMC1 versus placebo and then a multifactorial trial of IMC1 versus placebo versus the individual components that comprise IMC1 as a combination therapy. Patients who have an interest can progress from Study 1 or Study 2 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 3 partnership opportunities both to conduct the study as well as to develop an extended at least dosage formulation to extend the IP of IMC1 beyond its current intellectual property protection. We'll report out on that sometime in the first half of next year. And then we have IMC2, the combination of valsiclibir and celecoxib, the focus of a Phase 2 long COVID study.

Speaker 2

We had a proof of concept study complete in 2023. Mike will 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 2,044. Importantly, this study gave us the data to go to FDA and work out what the development requirements are for IMC2 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 has approved fatigue as the primary endpoint for development candidate.

Speaker 2

There's a 3 arm Phase 2 investigator initiated study ongoing right now, top line data of which we expect in the middle of this month. And with that background on the 2 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. Mike? Sure, Greg. So we did have

Speaker 3

a proof of concept study previously run by the Bateman Horne Center. This was an investigator initiated study where they were the first question was, was there any feasibility to show with applying this antiviral approach to a long COVID patient population? The Bateman Horne Center has a long COVID clinic where they had a number of patients 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 valsiclibyridetalacoxib to treat their long COVID symptoms. This study was conducted open label.

Speaker 3

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 a well matched group and then the comparison was reduction in symptoms of long COVID in the treated population versus the MASH control population. It's interesting to note that the duration of long COVID symptoms in this population was over 2 years in both groups. So this is a group of patients that had longstanding long 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 this slide with the study endpoints, there was fairly dramatic improvement in a number of symptoms this patient population.

Speaker 3

The primary endpoint was fatigue improvement. We see that this long COVID population looks quite a bit like chronic fatigue populations and the Bateman Heart Center is a specialty center in treating fatigue and pain conditions. They were very interested in seeing if we could improve fatigue in this population. And the NIH PROMISE fatigue score was used as primary. And again, you can see even though this was 22 patients compared to 17, it was highly statistically significant in favor of the antiviral treatment.

Speaker 3

Fatigue was also measured on a 0 to 10 numeric rating scale, sort of standard scale. It was improved on that as well. We saw some movement in pain. We asked a patient global impression of change question 2 different ways to ask the patient since they'd enrolled in the study how they were doing. And in both cases, the patients reported significant improvement in their quality of life.

Speaker 3

We also had 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 blackout. That's orthostatic intolerance. It's common in the long COVID population.

Speaker 3

And we saw significant movement on the orthostatic intolerance scales in this study as well. That was something the Bateman Heart 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 mood disorders probably because patients were feeling that their symptoms overall were improving. Now as I said, this was an open label study.

Speaker 3

This treatment was very well tolerated. We know that zelcyclovir has very little interaction with mammalian cells, so it's very well tolerated. Celecoxib is the best tolerated of the non steroidal anti inflammatories. So it really was not a surprise that it was well tolerated. We've seen that before with the other antivirals.

Speaker 3

But nonetheless, it really suggests 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 Baben 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 BHC. They've enrolled 45 patients that they randomized 3 arms, 1 to 1 to 1, a high doses, the antiviral combination, low dose antiviral combination and a placebo arm.

Speaker 3

That result is still blinded. We will be getting those results shortly, but we're looking forward to seeing if we can replicate the results we saw in the proof of concept study. Primary endpoint 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.

Speaker 3

So with that, that's our antiviral platform and where we stand on that. I'll turn it back to Greg to wrap up.

Speaker 2

Sure. Just one word about long COVID and the opportunities. Data are pretty clear that this is a major global event. Estimates from CDC suggest that long COVID has impacted around 400,000,000 individuals across the globe and has an annual economic impact of approximately $1,000,000,000,000 That's equivalent to about 1% of the global economy. Why is that?

Speaker 2

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 prevalent in the working population, hence the economic impact associated with this particular illness. In the U. S, we estimate that 6.5% of the non institutionalized U.

Speaker 2

S. Hot dog 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 paxlovid, which people had high hopes for, failed in its one long COVID trial.

Speaker 2

We think that's rational because we don't think long COVID is associated with the SARS virus, which is the focus of paxlovid. We believe it's the reactivation of secondary herpes viruses, which are delivering the symptoms and the sequelae that are associated with long COVID illness. The BHC results are shortly forthcoming and we believe one of the unique benefits of the formation of Dogwood is that it enables us ample time to consider the value enhancing development pathways that sit before us, both traditional financing and non dilutive funding options to advance IMC2 into Phase IIb development for the treatment of long covidomas. 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.

Speaker 2

We're very excited to report that out in the next week or so. The fibromyalgia program, IMC1 is poised to progress into Phase 3 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 2b interim data from the Helm Neuron cINP 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 Ali as our operator.

Operator

Thank you. At this time, we'll be conducting our question and answer session. Thank you. Our first question is coming from Jason McCarthy with Maxim Group. Your line is live.

Speaker 4

Hi, guys. Thanks for taking the questions. Greg, maybe you guys could talk a little bit about the Hal Neuron a little bit more rather, durability of response when patients stopped taking drugs. 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?

Speaker 4

And what do you hypothesize might be the reason for it?

Speaker 2

Jason, thank you for joining today. And I'm going to turn the question over to Doctor. General, who is best placed to answer that question for you.

Speaker 3

Sure, Jason. So in terms of durability 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 HAL neuron group and 10.5 days for the placebo group among responders. So if they were initial responders at 3 weeks, they were followed to see how long that response lasted. Now that's due to that's from a single cycle of 4 days of injections, twice a day for 4 days.

Speaker 3

We will not necessarily plan in long term to only use this for 4 days. This is an 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 injections do you need subsequently and so on. So we see hints of durability well beyond 4 days and whether it needs to be a week, 2 weeks, 4 weeks, 8 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, 3 doses were looked at.

Speaker 3

There was a quite low dose, a mid dose and a 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 2b study that's being planned right now.

Speaker 2

Yes. Jason, 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 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 preclinical work, animal work or human clinical trials and we'll endeavor to do so.

Speaker 4

And just in terms of the safety profile, I think I caught it earlier from the BID to the QD, it was a better tolerability profile. And I know there are unrelated mechanisms between opioids and neuron, but are any of those tolerability issues related to respiration or breathing difficulty?

Speaker 3

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. 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.

Speaker 4

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

Speaker 2

No, not at all. I was going to just add to Mike's comments that one of the things that was attractive to us about Honore is its specific focus on the 1.7 modulator as opposed to other NAV targets. There are NAV targets spread throughout the body. As Mike said, 17, 18 and 19 are primarily focused on pain signaling. And so that actually pulls through when you take a look at the tolerability data.

Speaker 2

I didn't mean to cut off the follow on question.

Speaker 4

Got it. Last question really quick. You had mentioned that 50% or so of TINT patients do use opioids because there is nothing else. Has FDA asked or do you think they'll ask for any information coming out of your trial on any reduction in the scripts for opioids or maybe opioid based rescue for any patients that might be having more severe pain?

Speaker 3

They will be interested to see if you have a reduction in rescue with treated patients versus control patients. 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 complicated. It's not just your treatment.

Speaker 3

And it's from a clinical trial standpoint, it's better to try and keep all the ancillary treatment medications constant throughout your study. This is going to be a 4 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 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 Haldneran.

Speaker 4

Got it. Thank you, guys.

Speaker 2

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

Operator

Thank you. Our next question is coming from Dave Boats with Zacks Small Cap Research. Your line is live.

Speaker 5

Hey, good morning, everyone. I was wondering if you could provide a few details on this, the Phase 2b trial for HalNeuron, anything 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?

Speaker 2

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 1, which is our goal.

Speaker 3

Sure. So Hal Nurin has been used in CINP before in that dose ranging proof of concept study I mentioned. We are going to use that as a background. The study we're designing, the 2b study we're designing is significantly larger. We are using the high dose dose once a day.

Speaker 3

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 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 better tolerated and potentially safer. In terms of the study itself, it's a 4 week long study. We will be dosing we'll be giving the same 8 doses that's been used historically.

Speaker 3

In the past, it was 4 days of twice a day dosing. We're going to go to once a day dosing for 8 days. It'll be spread over up to 2 weeks. So the same amount of total drug delivery will happen just in a different dosing format. We will primary endpoint will be at week 4, at which point patients will exit the study.

Speaker 3

It'll be 1 to 1 randomization against placebo, so traditional design with an interim analysis, as we have talked about scheduled for the second half of twenty twenty five. 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 4 week study. That's to set us up for a Phase 3 program where we already have some agreements with FDA about what a Phase 3 would look like in this indication.

Speaker 3

But this is our really proof of concept to do proper power calculations and get a handle on what it would take to get this through the approval process.

Speaker 2

Yes. 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 Halmauren as a really important new treatment.

Speaker 5

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?

Speaker 2

There are really no material obligations to meet to get that money in quarter 1 of Exteria, the intention is certainly to do so as long as we maintain good consistent listing standards and all those other things that are required as a public entity, we don't see any impediments, excuse me, to getting the additional $3,000,000 Okay. Ultimately, yes, 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.

Speaker 5

All right, great. Thanks for taking the questions.

Speaker 2

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.

Speaker 2

Yes. First off, thank you for those of you who joined this morning. Hopefully, you can tell, we believe the formation of Dogwood Therapeutics last month represents a very transformational event for us and in particular, the expansion of our pipeline to include Hal Neuron as a complement to IMC1 and IMC2. The concurrent strategic financing by CKLS' 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 Hal Neuron Phase 2b study, the interim readout specifically. It is our view that this is a win win for legacy Vireo shareholders and CKLS shareholders with both short term and medium term potential value creation opportunities associated with the forthcoming long COVID Phase 2 data for IMC2 and the Phase 2b data next year for Hal neuron.

Speaker 2

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 2 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.

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