Good morning, and welcome to today's Dogwood Therapeutics Incorporated Investor Call. At this time, all participants have been placed in the listen-only mode, and 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 Greg Duncan, Chief Executive Officer for Dogwood Therapeutics. Please proceed, Mr. Duncan. Thank you. Good morning, all, and thank you for joining today's exciting investor call for Dogwood Therapeutics. I'm pleased to be joined by our Chief Medical Officer, Dr. Mike Gendreau, and together we have the distinct pleasure of sharing how we at Dogwood Therapeutics are expanding our commitment to improve the lives of cancer patients who are suffering from the debilitating effects of chemotherapy-induced peripheral neuropathy, a condition for which there are no FDA-approved treatments. This expanded commitment is enabled by a very exciting global license to both develop and commercialize SP16, a first-in-class LRP1 agonist as a complement to our lead development compound, Halneuron. SP16 is administered intravenously and has demonstrated in preclinical research an exciting dual mechanism of action which we think has great utility for patients with chemo-induced neuropathy. Specifically, SP16 has both anti-inflammatory and analgesic effects, and that's complicated, excuse me, complemented by increased protein signaling that's associated with cell survival, cell growth, and cell proliferation. Succinctly put, SP16 could be used adjunctively with Halneuron as a treatment for chemo-induced peripheral neuropathy, and we also believe SP16 has potential to be used concurrently with chemotherapy to prevent or repair damage that's often associated with the off-target effects of chemotherapy, and I'm pleased to tell you this exciting new license is enabled by a highly efficient licensing deal. This is an all-stock transaction. The consideration is all Dogwood Therapeutics stock. SP16 is moving forward into phase I-B clinical research, and the forthcoming phase I-B trial is fully funded by the National Cancer Institute, so there's no need for Dogwood to utilize cash in the short term to get SP16 to its next important clinical milestone. We're very excited about the deal, and Mike and I will spend the next few minutes highlighting the details of that transaction as well as the exciting science that underpins SP16. Before we do that, though, we'd like to provide you with an update on the great progress we have on our ongoing Halneuron phase II-B chemotherapy-induced pain study. After we give you that great update, we'll talk about the SP16 deal, the science, and then finally we'll open up the discussion to questions about the SP16 deal or our Halneuron research program. So let me start with an update on Halneuron. For those of you who are not familiar with the program, Halneuron is a Nav1.7 inhibitor, sodium channel inhibitor, that's presently the focus of an ongoing phase II-B study. Halneuron effectively inhibits peripheral nerve transmission of pain signaling and has delivered clinical benefits to patients with both cancer and for those who have cancer and progressed to chemotherapy with the resulting neuropathy that's associated with chemotherapy all too often. We believe Halneuron has potential to treat broader cancer-related pain. We have completed a phase II study, and with success in the phase II-B CINP study, we think we can expand the Halneuron research program to include cancer-related pain, and we're also considering over time post-acute surgical pain study where we think Halneuron could have great benefit for patients. To summarize the benefits of Halneuron, for those of you who are new to our story, as I mentioned, Halneuron has reduced pain in both cancer-related pain studies and CINP studies. Two phase II studies completed to date. The response for patients who respond to Halneuron therapy is on average for about two months. There is no evidence of addiction, euphoria, or tolerance built up with continued administration of Halneuron. We have demonstrated a very acceptable safety profile in testing, including over 700 patients to date. We have composition of matter intellectual property protection that's complemented by both manufacturing know-how and trade secrets, and as I mentioned earlier, there are no drugs approved to treat CINP, highlighting the very large commercial opportunity that exists for a drug that gets to market, and we hope Halneuron will be the first to get to market to treat these patients who are in desperate need of novel new therapies. I'd like to provide you with an exciting update on the ongoing phase II-B study. I'm very pleased to tell you that under Mike's leadership, working with Ralph Grosswald, our Senior Vice President of Operations, we've already enrolled 82 patients into the current trial. By way of background in the trial, these are patients who will be administered either tetrodotoxin or Halneuron, as we call it, or placebo, so it's a two-arm study. Patients will be dosed with Halneuron over a course of two weeks, four injections week one, four injections week two, and we'll assess patients' pain scores over week one, week two, week three, and week four, and that average pain score at week four will be where we conduct the primary endpoint analysis. These are patients who have moderate to severe chemo-induced neuropathy. We will effectively assess patients not just on their pain reduction, but also from a global health perspective. We'll assess their fatigue, their anxiety, depression, and a whole battery of neuropathic pain symptom inventories. As we've communicated previously, and we're well on track based on the 82 patients who've currently enrolled, we're targeting enrollment of 200 patients subject to any modification of the phase II-B study by an interim analysis, which remains on target for quarter four of this year. We hope to assess the data in this interim analysis by December of this year. 82 patients in the study, over 50 patients have completed, and to date, only two patients have dropped out of the study, highlighting again the acceptable safety profile of Halneuron. We have very high conviction in this program and are very, very excited with the progress of the recruitment and the community's interest in this novel, important trial. Now let's turn our attention to the key features of the SP16 IV transaction. This is a royalty-free global license to both develop and commercialize Serpin Pharma's IV formulation of SP16 as a treatment for neuropathy and potentially to repair or prevent nerve damage that's associated with off-target effects of chemotherapy. SP16 provides alpha-1 antitrypsin-like activity, specifically by LRP1 agonism. Specifically, as I mentioned before, SP16 has demonstrated anti-inflammatory effects by a reduction of IL-6, IL-8, IL-1B, and TNF-alpha. These are cytokines as part of your immune response when overexpressed can actually cause damage, and that reduction in that type of inflammation is complemented by an increase in protein signaling, specifically for AKT and ERK, that regulate fundamental processes such as cell growth, proliferation, and survival. SP16 is a clinical stage asset poised to enter phase I-B treatment for patients with chemo-induced peripheral neuropathy. We're very excited about this candidate both on its own merit and its potential synergistic complement to Halneuron to reduce pain. As I mentioned before, the phase I-B trial is both endorsed and fully funded by the National Cancer Institute. The NCI grant proceeds are already sitting with Serpin Pharma. The study is to be run in collaboration with the University of Virginia to determine the best doses for phase II-A, and I'm pleased to tell you that based on communication between NCI and Serpin, the phase II-A study is also potentially eligible for NCI funding. We're currently planning to file an IND for this exciting new program in quarter four of this year and expect to commence dosing in patients in the first half of next year. A little bit more about the deal and the construct of the deal. We're very excited because Serpin has really terrific research expertise in this particular area. They've identified the active portion of alpha-1 antitrypsin and converted that into SP16. Serpin consideration for the deal is via DWTX stock. There'll be 382,000 common shares and 179 preferred shares, A2 shares, which will provide Serpin with ownership of DWTX stock of about 7%, 7.31% specifically, on a fully diluted basis. That calculation presumes a shareholder vote to convert preferred shares to common shares, which we anticipate sometime in quarter four of this year. The benefits to Serpin are that the DWTX or Dogwood Therapeutics management team has experience in late-stage development, specifically expertise in both pain and neuropathy conditions. As evidence of that expertise, both Mike and I have either developed and/or commercialized Celebrex, Lyrica, and Savella, three drugs that have actually gone through the development process and made it to market. The license includes a mutual support agreement between Serpin Pharma and CK Life Sciences to convert their respective preferred shares to common shares at this forthcoming special meeting. Serpin will own 7.31% of our shares on a fully diluted basis, and CKLS ownership will be 83% on a fully diluted basis post that conversion, subject to shareholder vote. That's important for us because it gives us a very large, stable shareholder, a shareholder that's committed to Halneuron and has been so for the past 15 years. Why are we excited about this? For those of you who know somebody who's had cancer, you know that cancer patients who progress to chemotherapy, and that represents about 50% of newly diagnosed cancer patients, often suffer from chemotherapy-induced neuropathy. In fact, roughly seven out of 10 patients, while they're going through chemo, experience neuropathy, in some cases so bad that patients peel off of their chemotherapy, the very treatment they're reliant on to save their lives. The group we're focused on is that 30% of patients who are full six months after their last diagnosed dose of chemotherapy are still suffering from neuropathy. That's a population that needs new therapies, and now we have a second shot on goal. Halneuron specifically inhibits pain signaling and has proven to have great potential to treat neuropathic pain. SP16, the LRP1 agonist, could also reduce pain by its analgesic and anti-inflammatory processes, but also has potential to reach numbness, tingling, muscle weakness, and loss of coordination, very troublesome symptoms of neuropathy as a complement to their pain symptoms and something that could be very complementary to our Halneuron focus on pain. So we're very excited about the second shot on goal, the complementarity and the synergy of these two potential assets used either alone or in combination moving forward. So that's an overview of the deal and the construct. I'd like to turn it over to Dr. Gendreau to talk through the science that underpins SP16 and to talk about the phase I-B trial that we plan to execute moving into 2026. Mike. Hi, thanks, Greg. My goal here is to cover some of the biology underpinning the activity of SP16, how it's complementary to our Halneuron program, and why we're very happy to add this to our stable development technology. As shown on the slide and as Greg summarized a little bit previously, alpha-1 antitrypsin is a member of what are called the Serpin family, and these are serine proteinase inhibitors, and they have a role in biology to offset the activity that happens with inflammation, with pathogens, with insults to cells such as chemotherapy. We get an inflammatory response that's evolutionarily protective of the organism, but you get local cell damage, you get inflammation, and what has evolved of this Serpin family is to offset or to restore the balance, to turn down that inflammation, to turn down the cell damage, and get back the homeostasis. So the alpha-1 antitrypsin is a member of that Serpin family, and it's important in regulating, as I said, inflammation. It has activity specifically on one of the enzymes that's important is neutrophil elastase. This is one of the proteases that causes damage. And what this activity of alpha-1 antitrypsin does is that, again, it restores the homeostasis. What Serpin and the company discovered was that the active part of alpha-1 antitrypsin could be reduced to a 17-amino acid peptide called SP16, which is the subject of this license, that has that same activity in terms of restoring homeostasis. So we now have a 17-amino acid peptide that can give us that activity that was previously required a large protein molecule. So LRP1 stands for low-density lipoprotein receptor-related protein 1. This is the molecule that's actually activated by SP16 or by alpha-1 antitrypsin that causes the molecular biology changes that lead to the reduction in inflammation and cell recovery, cell survival. All of these biological effects are related to this activity of LRP1, so that is the subject of the license, and we'd like to move on to the next slide here and talk a little bit about what LRP1 is specifically doing. As I said, it's LDL receptor-related protein. It is a signaling protein that's fundamental to cell biology. Almost all cells have it, and it's related to turning down inflammation, increasing cell survival, reversing apoptosis, and as shown in this slide, it really is something we want to have when we have damage to the cells, such as chemotherapy. We want to be able to reverse these effects, so that's what we have in terms of mechanism. On the next slide, it shows some of the activities we've seen with LRP1 activation. This is some preclinical work in mice that shows the ability of SP16 dosing to reduce both mechanical and temperature hypersensitivity that you get with nerve damage. In this case, this is a paclitaxel model where the chemotherapy agent, this is commonly used in breast cancer, for example, is given to the test animal. It causes nerve damage, and if we give SP16 in conjunction with the chemotherapy, we protect against that nerve damage, as shown by reduction in the pain signaling that you see in the animal that we get with the chemotherapy alone, and also a reduction in the mechanical hypersensitivity where they are very sensitive to touch. So giving SP16 in conjunction with chemotherapy seems to be protective against the neuropathic pain that results from the chemotherapy commonly. Next slide. Now, this is another pain model. This is a nerve ligation model where, again, the mice undergo a surgical procedure where you ligate the nerve and you directly damage the nerve, and what happens over time, if you do that and don't treat the animal in conjunction, again, they get very sensitive to pain, to touch, so that's mechanical hypersensitivity again. In this case, giving SP16 in conjunction with that surgical procedure is protective against the development of that mechanical hypersensitivity, again, showing that anti-inflammatory cell recovery ability that we're seeing with SP16 administration. Next slide. In another study that's been done by the Serpin Pharma in conjunction with the University of California, San Diego, they used a model to show that you can reverse nerve damage or be at least protective against nerve damage by having these neurotropic effects. Given SP16, you see nerve recovery and you see neurons sprouting, which is a sign that the nerves are regenerating. You're signaling to the cell to go into recovery mode where you protect the nerve and/or cause it to recover from whatever damage was done, in this case, with chemotherapy. Now, another important consideration as you start thinking about using this in conjunction with chemotherapy is that we need to make sure that the dosing of SP16 doesn't somehow interfere with chemotherapy itself. So this is a series of studies that were done to show and to convince the National Cancer Institute that SP16 would not interfere with the chemotherapy these patients need to receive when they're going in for their cancer chemotherapy. So on the left panel, we show that SP16 is being used with two common anticancer drugs, a platinum-class drug or a taxane-class drug. These are commonly used in breast and colon cancer. And what this study shows is that the effect of the cancer chemotherapy on the cancer cells is not diminished by the use of SP16 in conjunction. So you get very similar curves in terms of ability to kill the cancer cells with or without SP16 in conjunction. On the right panel is a different model. This is a pancreatic cancer model, again, done in a mouse model. And here we're using a different class of cancer drug. This is a PI3K inhibitor. And again, the addition of SP16 in conjunction with that cancer chemotherapy does not seem to diminish its cancer effect at all. So again, safe to use in conjunction with cancer chemotherapy, which was an important consideration when you consider we'd like to use this in conjunction with active chemotherapy for its protective effects. Finally, the study that's been funded by the National Cancer Institute that we'll be getting going in the first half of next year is a dose escalation study where patients with metastatic cancer will be eligible for the study who are receiving taxanes or platinum drugs that are known to cause neuropathy. In this case, there'll be cohorts of eight patients, six of which will get a Serpin SP16 dose, and two will get placebo in each of those cohorts. Every eight patients will, assuming the safety looks good, go to the next higher dose, and there's four potential dose escalation steps in this study design. Patients will get their baseline chemotherapy. They'll get SP16 or placebo in conjunction with that therapy. The study endpoints will be looking for safety, tolerability, prevention of neuropathy development, and whether the patients stay on their chemotherapy regimen. One of the problems we get with neuropathy in a lot of these patients is they can't keep taking the chemotherapy because of the development of neuropathy. So if we can protect against that, they're more likely to be able to complete their entire cancer chemotherapy regimen, which, of course, is very important for survival. So this is the plan that NCI is funding, and we said that'll be going in conjunction with the University of Virginia in the first half of next year. Thank you, Mike. So we're pretty excited about this. As you can probably tell, Serpin has a terrific scientific discovery that we helped you now apply in the clinic in this phase I-B study. Just to summarize from a deal rationale perspective, our conviction in Halneuron, late-stage asset best suited for treating the pain that's associated with chemotherapy, is now complemented by SP16, an LRP1 agonist, which we think can be used for both treatment of chemo, attenuation of chemo-induced peripheral neuropathy symptoms, but could have protective effects as well. What we also like about this is these are common call points. So the doctors that treat cancer and pain are relevant to both Halneuron as well as SP16. Co-promotion at targeting infusion sites and pain clinics, and both independently and together, allows us deeper penetration into the global CINP marketplace, which at present is estimated to be about $1.5 billion, with the potential to expand into cancer-related pain markets. The increased shots on goal, we really believe, is doubling down on our commitment to these cancer patients that go on to be treated with chemotherapy. There's value both as independent programs and in combination, and positive readouts in either arm create unique revenue pathways while combination studies are designed in the future, presuming success in both of the programs. So we're very excited about the complementarity of these two programs. I'm also pleased to tell you that by expanding the pipeline now to include SP16, we have a rich progression of milestones over the next 12 to 18 months, specifically for Halneuron. We expect to file new synthetic IP sometime this quarter. That new synthetic IP will allow us to reset our intellectual property protection clock a full 20 years, which will support phase III and commercialization moving forward. We expect to communicate recruitment of the 100 patients we are targeting with the interim analysis, with the interim analysis planned in the end of the fourth quarter of this year, with final data for a 200-patient study, presuming no change to the sample size, sometime in the middle of 2026, less than a year away. SP16, our novel new treatment development candidate for a broader milieu of peripheral neuropathy symptoms, will be underpinned by activities quarter four of this year to file the IND to support the phase I-B study, which is funded by the National Cancer Institute, and will begin enrolling patients sometime in the first half of next year. So we're very excited about the complementarity and now this broad, rich clinical milestone portfolio. I would like now to open it up to any questions that people on the call have. We'd be more than happy to answer specific questions about SP16, Halneuron, the complementarity, anything that you see fit to ask the management team. Mike and I are here to answer your questions. So Ali, I'll open it up back to you to open up to questions. Thank you, sir. Ladies and gentlemen, at this time, we will be conducting our question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. A 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 poll for questions. Thank you. We have a question from Sean Lee with H.C. Wainwright. Your line is live. Hey, good morning, guys, and congrats on this new transaction. I just have a couple of questions on SP16 deal and the clinical plan. So to start off, for the transaction itself, you mentioned that it's all stock with no royalties. So I was wondering whether there are any notable developmental or regulatory milestones associated with this deal. Thank you, Sean, for joining us this morning. It is an all-stock transaction with no royalty obligations, and there are no future development milestones associated with the deal. This is an all-stock transaction providing value to Serpin in the form of Dogwood stock, and that is the full consideration for the asset. Obviously, we hope to progress the asset through continued progress in the clinic, but that does not come with any future anticipated payments back to Serpin. Great. My second question is on the upcoming phase I-B study. How is SP16 dosed in these patients, and what's the expected primary efficacy endpoint that you are looking for? So the dosing is IV, so it's an intravenous infusion that's going to be done contemporarily with the chemotherapy itself. So it'll be done the same day. In terms of, well, I'm sorry, what was the second question? Primary efficacy. Primary efficacy. This is really going to be a tolerability and safety study. It's really first in man in being used for chemotherapy, and also the IV form is going to be first in man. So the primary from the National Cancer Institute, what they're funding is primarily looking at tolerability and safety. We will be looking for neuropathic endpoints, but that really is a secondary endpoint. Thank you. We are working with Cohava Gelber and the Serpin team and Dr. Dillon at UVA to finalize the design of this study, so the frequency of administration, what week in the chemotherapy dosing regimen is still TBD, but we have the opportunity, as Mike mentioned, to put in several exploratory endpoints to give us a sense of what would be in the phase II-A study from a proof-of-concept perspective. Got it. Thank you for that. My last question is on whether SP16 has gone any other previous in human studies before, since Serpin is a private company, so the information is not readily available? Yes, it has. Serpin, the company, has two other open INDs that have done other indications besides cancer chemotherapy. I don't know that they've disclosed the results of those, but there have been several other studies conducted to date. I see. Thank you for that. And that's all the questions I have. Thanks again for taking my questions. Thank you, Sean, for attending and for your questions, and happy to chat outside of today's call as you see fit. Thank you. As a reminder, ladies and gentlemen, if you have any questions, please indicate so now by pressing star one on your telephone keypad. Okay. As we have no further questions on the lines at this time, I would like to hand the call back over to Mr. Duncan for any closing remarks. Sure. Thank you. And once again, I want to thank you for those dialing in to today's call. We're very pleased to expand our commitment to cancer patients suffering from peripheral neuropathy. We're really excited about the SP16 license as a complementary asset to Halneuron. The asset has already demonstrated in preclinical research good anti-inflammatory activity to reduce harmful inflammation, complemented by increased protein signaling, which is essential to cell growth and survival. So a really interesting dual mechanism of action. We think it's a very efficient transaction. It's an all-stock deal, royalty-free, and the phase I-B study, which will include safety as a primary, but all these exploratory assessments that we hope to add into the protocol, is fully endorsed and funded by the NCI. Those funds are in hand with Serpin, so this program will start in the first half of next year. So our conviction in Halneuron is now complemented by our interest in the exciting new asset, SP16. We appreciate the time and energy, and as always, we'll provide updates as we progress through both clinical, IP, and other milestones. And I went through that list of milestones, so it should be a very active quarter four for us. And now with SP16, we're very excited to say the first half of next year, we'll put our second asset into the clinic. Thank you and have a very nice day. Thank you, ladies and gentlemen. This does conclude today's call. You may disconnect your lines at this time, and we thank you for your participation.