Conference. With me today is Mr. Greg Duncan, the CEO of Dogwood Therapeutics. Dogwood is a clinical-stage biotechnology company developing novel therapies for the management of chronic pain and other conditions. The company's leading clinical candidate, Halneuron, is being evaluated as a treatment for both general cancer pain and chemotherapy-induced neuropathic pain. With Halneuron currently progressing through a phase II-B study, in this conversation today, we want to explore the company's clinical and regulatory strategies, as well as other assets beyond the leading Halneuron. Please welcome Greg to this Fireside C hat. Good day, Greg. Glad to see you, and I appreciate you accepting our invitation to talk to our audience. To get us started, and for the benefit of investors who may not have heard of Dogwood, could you provide a brief introduction of the company and how it came about?
Sure, and thank you for having me today, Sean. Dogwood Therapeutics is a NASDAQ-listed biotechnology company. We are focused on developing novel new pain treatments, specifically non-opioid pain treatments that target a very common pain signaling pathway, the Nav1.7 sodium channel, to reduce the pain that's associated either with cancer or with the chemotherapy that's used to treat cancer, where we see very high rates of neuropathy. Specifically, everybody knows somebody that's had cancer. I'm sure most people know somebody that's gone through chemotherapy. About 70% of patients who go through chemotherapy have neuropathy at some point during their chemo, some of which actually have it so bad that they actually peel off their chemotherapy, which is a terrible state.
The group we're focused on right now are those patients who've gotten a cancer diagnosis, gone through their chemotherapy, and a full six months after the last chemo diagnosis still have persistent moderate to severe neuropathic pain. That is where we're focused with our lead asset, Halneuron, a Nav1.7 inhibitor, an injectable therapy used daily over two weeks to reduce pain for this particular neuropathy. The company was actually formed relatively recently. In fact, October of last year, we formed a business combination with Virios Therapeutics, a publicly traded company, and privately held WEX Pharmaceuticals. The rationale was very simple. Let's take a novel, really intriguing pathway and put it in the hands of a team that's managed several pain drugs. I'm pleased to tell you that between myself and my management team, we've gotten three or four pain drugs across the goal line here in the U.S.
and abroad: Celebrex, Lyrica, and Cimzia, drugs some have heard of. I'm sure household names in the case of Celebrex and Lyrica. It's really a nice combination of a team that knows the pain space, the clinicians, the regulatory authorities, with a novel new therapy. We're very excited to put that experience towards Halneuron so it can reach its full potential.
Yep, sounds great. Let us start by digging into Halneuron a little bit. As your primary asset, as you said, it's a Nav1.7 channel blocker, which is unlike any other pain medication that's approved so far. Could you provide us with a little bit of a background on the Nav1.7 inhibitors and how do they work in managing pain?
Sure, a great question. Maybe just to step back, for most healthy individuals, you have this signaling pathway from your peripheral nervous system into your central nervous system or your brain. Think of fire or some form of glass where you actually feel it at your extremities. That signal goes to your brain, and your basic response is to move yourself away from that negative stimulus. That pathway, that sodium channel pathway in the peripheral nervous system that we think is the most important, is the Nav1.7 pathway. I get a stimulus, hot stove, glass, pain that runs up through my brain, tells me to avoid that. What we know about this particular pathway is it's very effective both in preclinical models and in clinical models, and we can share some of that data in today's discussion, as a pain reduction mechanism.
We are really excited about this particular pathway based on what I would describe as a human knockout model. There's actually a group of people with a disease called congenital insensitivity to pain syndrome. We know these patients don't feel pain. They get third-degree burns, they break bones, torn ACL, because the stimulus that most normal healthy volunteers get to avoid that pain, to take your hand off the stove, does not work for these patients. The bad actor in congenital insensitivity to pain syndrome is no Nav1.7 function. We know a neuropathy, like chemo-induced neuropathic pain, that the damage, the off-target effects of the neuropathy excite these neurons that send pain signals. We know that hyperexcitability is what's causing the neuropathic pain signaling.
It stands to reason that if we can inhibit that process, dampen or reset that channel to get it less excited, we can deliver pain relief for patients. We see it in preclinical animal models. We actually have two studies, one in general cancer pain, the other in specific chemotherapy-induced neuropathic pain, showing Halneuron's potential to really change the standard of care for these patients. We are very, very excited about the pathway. I would mention one more thing, Sean. There have been other companies that have explored the Nav1.7 pathway. One of the things that was very attractive to us about Halneuron is its selectivity for Nav1.7. It doesn't have the off-target effects on, for example, cardiac NAV functionality that other programs have unfortunately run into.
We did a very careful review of the data, including cardiac safety data, and we're very pleased with the selectivity to target the particular channel we wanted to target. We think that could be a very key advantage for Halneuron® versus others that have preceded us in the NAV1.7 space.
I see, and that certainly sounds very interesting. Okay, as you mentioned, Halneuron has been investigated in phase II studies in both general cancer pain as well as chemotherapy-induced neuropathic pain. Why are you going after these cancer-related pain indications as your first indication? What are some of the key results from these previous studies that we should know about?
Sure, two reasons, simplistically. One, extraordinarily high unmet medical need. There's nothing approved to treat cancer-related pain or chemotherapy-induced neuropathy. There's a very large group of patients, millions of patients worldwide, who suffer from this pain. I think there's 20 million new cancer patients diagnosed each year. About half of them go on to chemotherapy. Both groups, those with or without chemo, suffer from pain. Unfortunately, in many cases, because nothing works, they wind up on opioids. Not only is it high unmet medical need, but we really are faced with this conundrum of the opioid crisis, downside of constipation, addiction, poor concentration. The unmet need is quite high. Halneuron has been studied in both general cancer pain and chemotherapy-induced neuropathic pain. As you referenced, we saw a statistically significant reduction in pain in cancer pain forms of all types, both with and without chemo.
About 51% of the patients in this particular trial treated with Halneuron showed a very good 30% reduction in their pain, which is the clinical standard, or a 50% reduction in their opioid use. It pairs quite favorably to placebo, which showed a 35% response rate. I would add one of the things we think is neat about the formation of this business combination is that that placebo response rate is actually quite high. Nonetheless, Halneuron was actually statistically significant. We think with better training, better education of the sites, and the patients, that placebo rate will go down. The relative effect size of drug versus placebo has the potential to get even higher. We saw really good results in this trial. We also saw a durable effect in these patients.
The predecessor company, WEX Pharmaceuticals, actually followed these patients after their last dose and measured the pain effect from the time of the start of the trial. In fact, if you look at the data, those treated with Halneuron responded for on average about 58 days after their last dose. The placebo group had an average duration of response of about a week, a week and a half, sort of markedly different profiles. We really think it's not just the acute effects, but the durability effects, which makes it very susceptible to pulse dosing. High unmet medical need, very good data in the space. We've actually got a second trial in chemotherapy-induced neuropathy where we assessed what doses, what administration route, and importantly, we're able to determine the effect size of drug versus placebo, which informed our ongoing phase II-B trial.
In this trial of about 200 patients treated with either Halneuron or placebo, we know what effect size to expect and have powered the study accordingly. We have 80% power. If that effect size holds up, we have an 80% probability of success.
Sounds good. As you mentioned, you already have pretty good results from previous studies in cancer-related pain. What is the primary purpose of the current phase II-B study in chemotherapy-induced neuropathy? Could you provide some details on the design of this study and what exactly are you hoping to achieve?
Sure, great question. 200-patient study. We're administering Halneuron once daily over the course of two weeks: four days week one, four days week two, and we assess the patients 30 days after they started the trial. From that first dose, 30 days later is the primary endpoint. That will be 200 patients. We're targeting patients with moderate to severe pain. The reason being is mild patients statistically show lesser response. When you're developing a drug, while it may have utility in mild disease, you tend to study the moderate to severe patients first because they have the most room to improve. The statistical approach is in your advantage. The trial, as I mentioned, is 30 days, and its basic premise is to inform the phase III program. The CIMP program has now been modernized, if I can say it that way, from what it was.
We shut down the prior program, met with FDA. We know the analgesia division quite well. We redesigned the study in a much more contemporary fashion. This study is a small replicate of what we would ladder up to in the phase III trial. This study is to determine the effect size, what's the sample size needed in phase III, what adjacent outcomes do we want to include in the trial, to take those data, show them on FDA, and then get the nod to move on to phase III as the potential first drug in the category. I would mention Halneuron enjoys fast-track review designation from FDA because of the novelty, the approach, and the unmet medical need in this space. A positive signal here, we think, also portends well for stepping back and looking at the broader cancer-related patient group as well.
As I mentioned before, 20 million new cases of cancer each year, 10 million go on to chemo. About a third of those have this durable neuropathy. If we can ladder up to the larger group, the commercial opportunity is very significant. I can tell you the unmet need is just as high. It can inform not just a CIMP trial in phase III, but could actually portend well for expanding the research program into more general cancer.
Yep, certainly sounds like it's an important step on your overall strategy. What's the latest progress then on this CIMP study? For investors, the most important thing is what's the next, what's the timeline to results?
Sure. I hear that all day long, so it doesn't surprise me that they might have that question. We started recruiting the trial in mid-March. We've recruited 58 or 59 patients. I think our 59th patient was going to be randomized today, which puts us on track to have somewhere between 80 or 100 patients completing the trial by November of this year, which sets up well for an interim data analysis in December. I will come back to that in a minute. Suffice it to say, what we've seen to date is 58 or 59 enrolled. We've had 41 patients complete, and we've only had two dropouts in the trial, which portends well for the relative safety and tolerability of the asset, which has been consistent through Halneuron's development, including in the prior trials.
Quarter four of this year, figure end of November to December, we expect to communicate on interim results from the trial. Effectively, we'll take the data. We remain blinded. We will share it with external statisticians with rules that come back to assess one of four things: futility, which basically is a placebo-beating drug, which we think is highly unlikely given the success we've had in trials to date. It could be statistically significant on 100 patients, which would be wonderful. Remember, we project we need about 200 patients. This will be about half that sample size. The two most likely outcomes will be stay the course because the effect size is at or about what you thought, so stay with 200 patients.
That will give us final data in the middle of 2026, or they may come back and say your effect size is actually 0.38 rather than 0.4, and as a consequence, you need to go to 220 patients, for example. This repowering exercise will preserve our 80% power for the duration of the trial. As long as we stay in the ballpark of about 200 patients, interim results December-ish, end of this year, final results middle of 2026. Those are two key clinical milestones. I will also mention that we are working on a synthetic formulation of tetrodotoxin, the active ingredient in Halneuron. One of the reasons we were attracted to this asset was it's the only company historically that's been able to produce tetrodotoxin at a clinical scale level. The manufacturing and trade secrets, the IP is all predicated on this unique collection mechanism.
One of the key final items of our diligence was the progression of a synthetic formulation, i.e., man-made formulation, which the FDA likes better. Importantly, we've already established chemical equivalence with this new formulation. We hope to effectively progress a synthetic formulation into phase III and commercialization, which improves yield, reduces costs, and is much more regulatory or FDA-friendly. We're very excited about that milestone. New IP sometime in the next month or so to be filed. Interim results in quarter four. Full data from the trial in the middle of 2026.
Certainly sounds like a very busy 12 months ahead for the company.
We certainly hope so.
All right. Looking a bit further ahead, assuming this phase II-B is successful, what's the next step in the development of Halneuron? What is your general regulatory strategy going forward?
Yeah, great question. When you develop and launch a Celebrex or develop and launch a Lyrica, you effectively get to know the analgesic division at the FDA. We know them well. We know what their interests are. In fact, our Chief Medical Officer actually designed the approval criteria as a consultant back in the day for the FDA for approval of neuropathy drugs. We know the pathway quite well. We will take these data. We understand exactly what's required for approval. We will build out the program with the FDA. Some companies have this view that you have to fight with the FDA to get what you want out of it. We take a very different approach. We think working with them to come up with something that is executable and they are looking for is the way to do that.
We will take those data, call it end of 2026, share our proposed phase III program. We have a very good idea right now of what that will look like with the goal of executing the phase III program in the beginning of 2027. We will also, in the interim, be scoping out a broader cancer-related pain study. In fact, we'd like to consider a post-surgery acute pain study. I mentioned before that the drug looks to work for about two months in patients with chemo-induced neuropathy. Think of somebody that's just had knee or hip replacement. I can because I just had hip replacement. I think of them giving me a shot of bupivacaine to get me through 24 hours. Ultimately, I was handed two smoky brown bottles of opioids to get my pain to be controlled so I could start my rehab as soon as possible.
If we had a drug that you could inject into the operation site and give people even two weeks of therapy, you could revolutionize post-surgical care. Good signal here on CIMP. Get down to the FDA to scope out phase III. We would likely go down and get their feedback on a broader cancer-related pain study, as well as a smaller post-surgery acute pain study. Lots of things to evaluate, presuming we get the signal we hope for in quarter four of this year.
Yep, okay. Certainly looking forward to that. For the last question on the Halneuron side, I know you mentioned it a little bit, but what's the IP situation looking like for Halneuron? I know this may be a little early, but do you have a commercial strategy that you're leaning towards at this point? I know pain is such a big market, both in the U.S. and worldwide.
For sure, for sure. Let me address the IP first and I'll come on to commercialization. The process to collect tetrodotoxin from the ovaries of pufferfish, as you can imagine, is very difficult. You have to find the fish. These fish migrate. As the ocean warms, these fish go from one area of the world to another area of the world. The yield is difficult. We were really, frankly, shocked at how well WEX Pharmaceuticals had developed this process. The trade secrets, the know-how, the methods, the manufacturing patents are the basis for what the IP is right now. We're anchored to that IP. Importantly, that synthetic formulation I referenced earlier will allow us to potentially file IP within the next 30- 60 days with the goal of completely resetting the patent clock. That would be a seminal event for the company. That would give us maximum runway.
Think of most companies don't get to reset their patent clock in the middle of phase II-B. We're really excited about that as a way to bolster, put another moat around the castle from an intellectual property protection based on a composition-of-matter filing because of the unique way we're going to develop this compound. On the commercial side, as you said, it's early. I've come from a commercial background with about 18 years of commercial background at Pfizer. Partners are critical for small companies, but it's not the only way to go. We know the space well. We understand how to run development programs. I also understand that my ability to create value for our shareholders is maximized with good data in hand. The data will dictate the strategy.
If the data are great and somebody says, "Hey, I must have this and I can create massive value for Dogwood Therapeutics shareholders," we do that. If what comes up is okay, then we continue to finance it and wait till we get the best hand to play, if you will, with a registration package, for example. We're always open to creating value. We'll evaluate any opportunity, but we're not in a rush to create a partnership right now because we know the space well. We have confidence in the asset. As I mentioned through our update on the trial, we're recruiting on time, on budget, as projected. We're very excited about that.
Sounds great. Maybe to finish this off with a couple of questions on the finance side of things. What's the company's current cash position like, and what's your expected cash runway?
As we communicated with our Q2 earnings release, we have a little over $13 million, roughly $13.5 million of cash on hand. That's funding everything from research to general admin. We do run a pretty tight ship. We're running the company on, let's call it, about 12 or 13 employees, half of which are full-time, the rest are consultants, and so the burn is low. That low burn gets us through Q1 of next year. We'll get to the interim data and decide whether we want to expand our shareholder base and complement our current retail base, plus CK Life Sciences, our largest shareholder, and some other institutional shareholders. Those institutional shareholders could be as interested in acute pain post-surgery as they are in CIMP, for example.
CK Life Sciences certainly has the capability to fund the program to its completion, given the size of CK Life Sciences, which is a Hong Kong-listed company, which actually rolls up into Li Ka-Shing and his group over in Asia. The optionality there with good data, I think, is terrific. We're very excited about that.
Okay, sounds good. That's it for me. Thank you very much, Greg, for joining us for this Fireside Chat. It was very informative, and I hope it's helpful for the investors as well.
Thank you, Sean. I really appreciate it. Happy to talk about Dogwood Therapeutics at any time.
Great. Thank you.