Q3 2024 Dogwood Therapeutics Inc Earnings Call
Good morning and welcome to the Dogwood Therapeutics Incorporated third quarter 2024 earnings call.
Speaker Change: 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.
Speaker Change: At this time, I'd like to turn the call over to Angela Walsh, Chief Financial Officer for Dogwood Therapeutics. Please proceed, Miss Walsh.
Angela Walsh: 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' third-quarter financial results and to provide a corporate update. Please note that our financial results press release is now available on our website.
Speaker Change: Litigation Reform Act of 1995, which involved risks and uncertainties that can cause actual results to differ materially from the information expressed or implied by these four looking statements.
Speaker Change: For more information regarding such risks and uncertainties, please see the risk factors outlined in the company's filings with the SEC.
Speaker Change: 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, Dr. Mike Genro, to provide our corporate summary and highlights related to our recently announced business combination, which formed Dogwood Therapeutics.
Speaker Change: Our financial results for the third quarter 2024 were published this morning in our press release and are available on our website.
Speaker Change: Therefore, I will just provide a brief summary of our financial status on today's call.
Speaker Change: As of September 30, 2024, Dogwood Therapeutics' cash totaled $2 million.
Speaker Change: On October 7, 2024, we announced a business combination with Pharmagesic Holding Incorporated, the parent company of Wex Pharmaceuticals Incorporated, to form Dogwood Therapeutics.
Speaker Change: A key component of the combination was a concurrent $19.5 million strategic financing by an affiliate of CKLS.
Speaker Change: CK Law Sciences International Holdings Incorporated, a Hong Kong exchange listed company and an indirect parent company of Pharmagesic and Lux Pharmaceuticals.
Speaker Change: We have received $16.5 million in loan proceeds in connection with this financing.
Speaker Change: with an additional $3 million expected to be received in February 2025, resulting in approximately $23 million in working capital, including combined cash of the entities at the time of the culmination.
Speaker Change: Based on our projections, this should fund research and operations through 2025 and through several key milestones.
Speaker Change: 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 HAL Neuron Phase 2b interim analysis assessment expected in the second half of 2025.
Speaker Change: We expect to follow the Form 8KA with the Combined Entities Financial Statements in mid-December of this year and look forward to keeping you updated on our progress. Now it is my pleasure to turn the call over to our CEO, Greg Duncan, to provide our Corporate Summary. Greg?
Greg Duncan: 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 various therapeutics and wax pharmaceuticals.
Speaker Change: 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.
Speaker Change: Mike and I will provide you with highlights on our three late-stage programs with a particular focus on the newest addition to this pipeline, Hell Neuron.
Speaker Change: 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.
Speaker Change: 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 iratdwtx.com.
Speaker Change: Before diving into the specific programs I thought I might just summarize or refresh the highlights of the transaction to Foreign Dog with Therapeutics.
Speaker Change: Germaine to this formation was an expansion of our pipeline to include Hal neuron
Speaker Change: currently projected to have interim data in the phase 2b program for chemotherapy induced neuropathic pain in the second half of next year.
Speaker Change: 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 million to fund operations.
Speaker Change: 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.
Speaker Change: Additionally, IMC2, a combination of valsiclovir and cellococci, is the focus of a phase 2a study run by the Bateman Horn Center and we have data expected in the middle of this month.
Speaker Change: As part of the transaction, our various stockholders, as of October 17, were granted a Contingent Value Right, or CVR as you may know it, tied to potential future milestone payments.
Speaker Change: associated with future partnering transactions for IMC1 or IMC2, particularly related to development or regulatory milestones.
Speaker Change: 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 Cevela.
Speaker Change: As you can see on slide number four, in addition to Angela, Mike, and myself, we'll be presenting today, we have Ralph Grosswald, who is our Senior Vice President of Operations, and Meng Zhou, our VP of Manufacturing. You can see the companies the team has worked at, have extensive training and experience.
Speaker Change: 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 how neuron and the lifecycle opportunities in this new addition to our portfolio
Speaker Change: Speaking of our portfolio, as you can see arrayed on slide 5, we now have the expanded Dogwood Therapeutics pipeline, which targets several areas of medical need and has, in our opinion, very significant value creation potential.
Speaker Change: There are really two pillars to the pipeline. First is the NAV1.7 platform, the focus of which is how neurons, and specifically our Phase IIb program in chemo-induced neuropathic pain.
Speaker Change: I will mention we're excited about data, some data that Mike will share with you in the next few moments.
Speaker Change: and how neurons 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.
Speaker Change: 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 antiviral program featuring IMC-1, the combination of famciclin and alciclir,
Speaker Change: and the Long COVID or PAST program, which features IMC-2, which is a combination of valacyclovir and celotoxib.
Speaker Change: 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.
Speaker Change: So with that background, let me turn it over to Dr. Gennaro to talk a little bit about the mechanism of the NAV1.7 platform and some of the data that has us really excited about L neurons potential.
Speaker Change: propagate electrical signals through them to the spinal cord and ultimately to the brain, and the particular
Speaker Change: Nav 1.7 channel, which Hell Neuron is specifically targeted for, is very involved with peripheral pain.
Speaker Change: So there's nine known sodium channels, some of which are more involved with cardiac conduction and other parts of the body, but the NAB 1.7, 1.8 and 1.9 are those that are most associated with pain and inflammation.
Speaker Change: 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.
Speaker Change: and we'll talk about the opportunities for what we think the applications for Helnurin 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.
Speaker Change: That is, they took people who had cancer, had pain from that cancer, and then treated them with injections of Hal-Neuron 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.
Speaker Change: In that study generated statistically significant reductions in pain, you know in a study that had enrolled a hundred and sixty-five patients That was encouraging to us and we were specifically
Speaker Change: encouraged by the duration of the improvement we saw in some of those patients, which we'll talk about in a minute.
Speaker Change: The other study that was done prior to our combination was a Phase IIa signal-seeking study in chemotherapy-induced neuropathic pain. So that is the indication our next study will be focused on.
Speaker Change: 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
Speaker Change: So, given that background, we were very excited about the potential for Hal-Neuron in treating pain secondary to chronic conditions like cancer-related pain.
Speaker Change: So, this is data from that cancer-related pain I mentioned, where we had statistically significant results in terms of pain reduction.
due to Hal neuron. This is a responder analysis.
Speaker Change: where we looked at patients who had at least a 30% reduction in pain from their baseline before they were treated with Hal-Neuron. And what we saw was that there was a statistically significant increase in the rate of response.
Speaker Change: in the patients treated with Haloran 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.
Speaker Change: 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.
Speaker Change: If they were a responder, they would continue to be followed on a weekly basis to see how long that pain improvement lasted.
Speaker Change: And as they continue to be followed, you can see that...
Speaker Change: 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.
Speaker Change: was on the order of 10 days before they lost their effect. The mean change in the Hal-Nurin 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.
Speaker Change: between the duration of 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
Go to the next slide, please.
Speaker Change: I think, Greg, we're going to hand it back to you 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 three doses and two different dosage regimens of HAL neuron to treat specifically CINP.
Speaker Change: The results of this study are arrayed 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.
Speaker Change: 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 colorability profile.
Speaker Change: How neuron pain relief was evident four weeks post-treatment in this particular study and the how neuron high doses in particular delivered clinically meaningful pain reduction for 35 to 40 percent of patients in this relatively small study.
Speaker Change: A CINP, we believe, represents a very significant market opportunity. Presently, there are no FDA-approved treatments for chemo-induced neuropathic pain.
We know from our
Speaker Change: secondary market research data that more than half of the sales for the global pain market are actually prescribed for opioids.
Speaker Change: 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
Speaker Change: or reduce the utilization of opioids. We have something that's, commercially speaking, a winner.
Speaker Change: Over time most patients get some form of neuropathic pain. If you look at the background data for chemo there's 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%.
Speaker Change: But even at six months, you have 30% of patients exhibiting neuropathic pain. This is six months after the discontinuation
Speaker Change: of the Ochemotherapy. 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 chemo-induced neuropathic pain patients.
Speaker Change: in just those territories, when you add in developing markets and other potential markets across Europe.
Speaker Change: you have well north of two and a half million patients.
Speaker Change: that are actually suffering from chemo-adduced neuropathic pain. So, the size of the opportunity, the heavy utilization of opioids.
Speaker Change: 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.
Speaker Change: 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 pain therapeutics and specifically non-opioid in its particular mechanism.
Speaker Change: This is a validated mechanism supported by both preclinical and clinical data
Speaker Change: We've seen, as Mike and I just shared 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 space well both from a development and a commercialization potential.
Speaker Change: So we are really excited to add Hell Neuron to the Dogwood Therapeutics pipeline and are very excited about the interim analysis we plan for the second half of next year
Speaker Change: 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 unmet medical need.
Speaker Change: IMC1 is poised to progress into phase three 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.
Speaker Change: We have agreement with FDA based on our Phase IIb study for a four-part Phase III program. That program will consist of a pharmacokinetic and food effect study with a new formulation. We progress into Phase III development for fibromyalgia.
Speaker Change: two 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.
Speaker Change: 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.
Speaker Change: We're presently exploring Phase III partnership opportunities, both to conduct the study as well as to develop an extended release dosage formulation to extend the IP of IMC1 beyond its current intellectual property protection.
Speaker Change: We'll report out on that sometime in the first half of next year. And then we have IMC-2, the combination of valsiclavir and silicoxib, the focus of a phase 2 long COVID study.
Speaker Change: We had a proof-of-concept study complete in 2023. Michael will share the data with you that have us excited about this particular mechanism. That study allowed us to file a new IP with patent protection if granted to 2044.
Speaker Change: Importantly, this study gave us the data to go to FDA and work out what the development requirements are for IMC2 to treat long COVID symptoms. And in particular, we've now agreed with FDA that for the first time to our belief.
Speaker Change: is the first time FDA has approved fatigue as the primary endpoint for a development candidate.
Speaker Change: There's a three-armed phase two investigator-initiated study ongoing right now, top-line data of which we expect in the middle of this month.
Speaker Change: 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?
Mike Genro: Sure, Greg. So, we did have a proof-of-concept study previously run by the Begman-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?
Speaker Change: The Bateman Horne Center has a long COVID clinic where they had a number of patients they were monitoring and taking care of.
Speaker Change: 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 L-Cyclovir and Celecoxib to treat their long COVID symptoms.
Speaker Change: This study was conducted open label, so these 22 patients were aware they were getting the antiviral treatment.
and their results were compared to 17 match controls.
Speaker Change: from the same population and they were matched for their gender, for their age, for how long they'd had long COVID, whether they'd 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 mass control population.
Speaker Change: 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 longstanding, long COVID, had been difficult to treat with other therapies, and then.
Speaker Change: treated with this antiviral combination to see if we could really improve their symptoms.
Speaker Change: And as you can see on the slide with the study endpoints,
Speaker Change: There was a fairly dramatic improvement in a number of symptoms in this patient population.
Speaker Change: They were very interested in seeing if we could improve fatigue in this population. And the NIH PROMIS 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 Change: Fatigue was also measured on a 0 to 10 numeric rating scale sort of standard scale.
Speaker Change: who's improved on that as well. We saw some movement and pain. We asked a patient global impression of change question two 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.
We also had an assessment of orthostatic intolerance.
Speaker Change: 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
Speaker Change: on the orthostatic intolerance, it's common in the long COVID population, and we saw significant movement on the orthostatic intolerance scales in this study as well. That was something the Bateman Horne Center was specifically interested in. It was new to Dogwood, but we were quite pleased with the results that we saw on this orthostatic intolerance.
Speaker Change: scale, and we even saw some movement in mood disorders probably because patients were feeling that their symptoms overall were improving.
Speaker Change: really suggested this could be a first-line treatment if it continues to do well.
Speaker Change: Being open-label, we wanted to confirm this in a more classic double-blind placebo-controlled study.
So we did approach
Speaker Change: David Horne 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 at three arms, one to one to one, at high doses, the antiviral combination, low-dose antiviral combination, and a placebo arm.
Speaker Change: That result is still blinded. We will be getting the results shortly.
Speaker Change: But we're looking forward to seeing if we can replicate the results we saw in the proof-of-concept study.
Speaker Change: Primary 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.
Speaker Change: And as we've already mentioned, the top line results are expected in the next few weeks.
Greg Duncan: So with that, 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.
Greg Duncan: Data are pretty clear that this is a major global event. Estimates from CDC suggest that long COVID has impacted around 400 million individuals across the globe.
Greg Duncan: 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.
Greg Duncan: 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.
Greg Duncan: In the U.S., we estimate that six and a half percent of the non-institutionalized U.S. adult population has experienced long COVID since the introduction of COVID back in 2019 or 2020.
Greg Duncan: As Youre, probably aware, there's nothing approved to treat non covered by the food and drug administration and to date therapeutic research has exhibited very little progress.
Greg Duncan: 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.
Greg Duncan: Notably Pfizer's tax a little bit, which people had high hopes for failed in this one long cobalt trial, we think that's rational because we don't think long cobalt is associated with the Sars virus, which is the focus of tax law, but we believe it's the reactivation of secondary herpes viruses, which are delivering the symptoms and the sequela associated with loan Covid illness.
Greg Duncan: notably Pfizer's Paxilovir, which people have high hopes for, failed in this 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 Paxilovir. We believe it's the reactivation of secondary herpesviruses, which are delivering the symptoms and the sequelae that are associated with long COVID illness.
Greg Duncan: The Bac results are shortly forthcoming.
Greg Duncan: 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 set before us both traditional financing and non dilutive funding options to advance <unk> two into phase II phase III development for the treatment of long cause of illness.
The BHC results are shortly forthcoming.
Greg Duncan: And we believe one of the unique benefits of the formation of dogwood is that enables us ample time to consider
Greg Duncan: the value-enhancing development pathways that sit before us, both traditional financing and non-dilutive funding options, to advance IMC2 into Phase 2B development for the treatment of long-COVID illness.
Greg Duncan: And really just to summarize on our next updates, but we believe this pipeline has very significant value creation potential alone Cobra data are due in the middle of this month, we're very excited to report that out in the next week or so.
And really just to summarize on our next updates.
Greg Duncan: We believe this pipeline has very significant value creation potential along COVID data are due in the middle of this month We're very excited to report that out in the next week or so
Greg Duncan: Fibromyalgia program I M. C. One is poised to progress into phase III and we'll do an update on partnership in the first half of next year and then as Mike went through very nicely. We have the phase two be interim data from the Hal neuron C. O M. P program due in the second half of next year.
Greg Duncan: 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 Hell Neuron CIMP Program due in the second half of next year.
Greg Duncan: With that background to the program, let me open it up to questions. So back to you Ali as our operator.
Greg Duncan: With that background to the program, let me open it up to questions. So back to you, Ali, as our operator.
Speaker Change: Banki at this time, we'll be conducting a question and answer session.
Greg Duncan: Thank you. At this time we'll be conducting our question and answer session.
Speaker Change: If you would like to ask a question. Please press star one on your telephone keypad.
Greg Duncan: If you would like to ask a question, please press star 1 on your telephone keypad.
Greg Duncan: A confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue.
Greg Duncan: The confirmation tone will indicate your line is in the question key.
Greg Duncan: And you may press star two if you would like to remove your question from the queue
Greg Duncan: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Greg Duncan: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Greg Duncan: One moment, please while we poll for questions.
One moment please, while we poll for questions.
Speaker Change: Thank you.
Speaker Change: Our first question is coming from Jason Mccarthy with Maxim Group Your line is life.
Greg Duncan: Thank you. Our first question is coming from Jason McCarthy with Maxim Group. Your line is live.
Jason Mccarthy: Hey, guys. Thanks for taking the questions. Greg maybe you guys could talk a little bit about the how neuron.
Greg Duncan: Hi guys, thanks for taking the questions. Greg, maybe you guys can talk a little bit about the Hal neuron, a little bit more rather, durability of response when patients
Greg Duncan: A little bit more rather a durability of response when patients.
Greg Duncan: Stop taking drugs was how far out that that goal kind of what are you and is there a dose response high versus low that's associated with that and what do you hypothesized might be the reason for it.
Greg Duncan: 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
Speaker Change: Well, Jason Thank you for joining today and I'm going to turn the question over to Dr. General who is best placed to answer that question for you.
Speaker Change: Well, Jason, thank you for joining today. And I'm going to turn the question over to Dr. General, who's best placed to answer that question for you.
Dr. General: Sure Jason So in terms of durability of response. The study that was conducted that had durability information with that cancer related pain study we showed.
Speaker Change: The median.
Speaker Change: Response time are that actually average response time was 57 days for the.
Speaker Change: response time or the 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 three weeks they were followed to see how long that response lasted.
Speaker Change: Hell neuron group and 10.5 days for the placebo group among responders. So if they were initial responders are three weeks. They were followed to see how long that response lasting.
Speaker Change: Now.
Now,
Speaker Change: that's due to that's from a single cycle of four you know four days of injections twice a day for four days