Dogwood Therapeutics, Inc. Common Stock Status update

Please go ahead, Greg. Thank you very much, Tara, and welcome to everybody attending this morning's presentation.

We're delighted to share why we're so excited about Halneuron as a potential new treatment for patients who are suffering from chemotherapy-induced neuropathic pain. For those of you who are new to the Dogwood story, Dogwood is a clinical-stage biotech company. We are focused on novel new treatments for both pain and neuropathy. We believe our approach is further differentiated given our focus on cancer and chemotherapy-related pain. We have two assets in the pipeline. We'll spend most of the time today on Halneuron, which is a NaV1.7 inhibitor, but we also have SP16, an LRP-1 agonist, which is poised to go into development as adjunctive therapy alongside chemotherapy to prevent immersion to neuropathy during chemotherapy treatment.

The trial will likely dose patients the second half of this year, and the trial is fully funded by the National Cancer Institute based on very exciting preclinical data supporting the program. I'm also pleased to tell you I work with a terrific team. We have a team that has extensive experience in developing blockbuster medicines, including two significant additions to the pain armamentarium, CELEBREX and LYRICA, several billion-dollar drugs, or drugs that have either been developed and/or commercialized by our team. We have a group of people who have managed successful pain programs and are bringing that effort to bear on the development of Halneuron. Next slide, please. We will be making forward-looking statements during today's presentation. All of our forward-looking statements are contained in this presentation are relevant as of today, September 1, 2026. Next slide, please. I'm pleased to tell you we've assembled a first-class faculty for today's presentations.

We'll go through several topics. Our first speaker is Dr. Iain Dukes. Iain is a venture partner at OrbiMed who brings more than 20 years of pharmaceutical research and development and business development leadership to today's discussion. Iain has deep experience in the field of ion channel therapeutics, and this is obviously quite relevant to the development of Halneuron, our NaV1.7 sodium channel inhibitor. He was previously a board member of Kartos Therapeutics, which Ipsen acquired last month. Iain previously led all licensing deals for Merck Research Laboratories as the Senior Vice President for Business Development and Licensing, and has held senior R&D roles at both Amgen and GlaxoSmithKline. Earlier this summer, we were pleased to welcome Iain as the chairman of our scientific advisory board.

Today, Iain will speak to the role of Nav ion channels in pain signaling and how Halneuron differentiated mechanism of action. Next up will be Dr. Mike Gendreau, our Chief Medical Officer, who has led Dogwood's clinical development programs since early 2021 and has been guiding the Halneuron phase IIb study from its design through enrollment, which I'm pleased to tell you exceeds 230 patients as of today in the ongoing trial. Mike's career spans senior R&D and Chief Medical Officer roles at Cypress Bioscience, where incidentally he helped bring SAVELLA through FDA approval for fibromyalgia, another pain condition, and MicroProbe Corporation, along with two decades of independent consulting on late-stage pain and CNS drug development programs.

Mike will walk us through the phase IIb clinical research summary to date and share with you what you can expect when we unblind the ongoing phase IIb study later this fall. Following Mike, we're joined by Dr. Mark Joyce, a board-certified psychiatrist and investigator with CNS Healthcare of Jacksonville since 2003. Mark earned his MD from the University of Alabama and completed his psychiatry residency at my alma mater, Emory, and presently serves as a site investigator on our current Halneuron phase IIb study. Mike will share his perspective on the unmet need in chemotherapy-induced neuropathic pain and his blinded observations from the ongoing trial. Finally, we're joined by Dr. Jerry Evarts, a chemistry and manufacturing specialist with over 20 years of industrial experience in small molecule synthesis, including CMC leadership roles at Calistoga, Acerta, and Day One Bio.

Jerry has supported programs from early scouting through phase III and NDA submission. At Dogwood, he's overseeing the complex synthetic manufacturing of tetrodotoxin, a process requiring more than 30 complex synthetic steps to the development of Halneuron drug product. Jerry will provide us with an update on advancing the first-ever synthetic formulation of tetrodotoxin to support Halneuron phase III development and ultimately commercialization. At this point, we're going to turn off the camera to maximize view on the slides. We'll bring the speakers back on camera as we get to the Q&A. Next slide, please. I thought it would be helpful to give you a sense of the patient journey, as we progress Halneuron through its development, because this is ultimately what the problem we're trying to solve.

As you may be aware, chemotherapy-induced neuropathy results in somewhere between two-thirds and three-quarters of patients experiencing some form of neuropathy, most notably for today's discussion, moderate to severe pain. These patients can also experience numbness, tingling, sensitivity to cold, insensitivity to temperature, muscle weakness, and balance disturbance. Gait disturbance, if you will. As I mentioned, it's roughly 2 out of 3 or 3 out of 4 patients who experience this as they go through their chemotherapy because of the off-target damage to the neurons in the periphery, generally speaking, the hands and the feet. When oncologists observe this, there's several courses of action they can take. If the pain tends to be mild, the doctors will wait and watch and continue on with the chemotherapy treatment regimen. Unfortunately, as that pain goes to moderate to severe stages, we begin to think about altering the chemotherapy regimen.

At moderate levels of pain, oncologists will often either reduce the dose or increase the intervals between doses for patients who are being administered chemotherapy. That is a terrible outcome, but it gets even worse when we get to severe pain, where doctors and the patients have to come to the very difficult choice of on, off. Do they carry on with the chemotherapy, or do they stop the chemotherapy altogether? This problem is not inconsequential. This is germane to patients maximizing their chemotherapy regimen. At present, oncologists are not treating the pain component of chemotherapy-induced neuropathic pain. Those patients get referred to a pain specialist, often a neurologist, anesthesiologist, or an internist with a specialty or a pain clinic specifically. At present, these pain specialists are left with very little choice. Right now, the most commonly used drugs are used off-label.

That includes duloxetine, or Cymbalta, as you may know it, pregabalin or gabapentin, the alpha-2 deltas, and opioids. Unfortunately, none of these drugs really get the job done once you get to that moderate to severe stage for most of these patients. As Mike Gendreau will come on to tell you in a minute, we have about half of the patients in our current trial who are on these medications, yet still qualify for having moderate to severe pain. That pain specialist represents our initial call point.

Based on the profile that is emerging with Halneuron, which appears to be quite safe, have little incidents with other drugs and drug-drug interactions, we think over time, oncologists represent a very significant market development opportunity as we consider lifecycle management plans where we plan to, presuming success in the current trial, move upstream and use Halneuron concurrently with chemotherapy, not just to address the pain, but potentially to maximize the efficacy of the chemotherapy regimen. The less tinkering we do with that regimen, the better the outcomes are likely to be. That is the patient journey. These are ultimately the patients whose lives we hope to help as we move forward with Halneuron's development. Next slide, please. To quantify this, and I will use U.S. data, I will provide a global estimate in a minute, there are about 18.5 million cancer survivors in the U.S. as of today.

A little under 58% of those patients are treated with chemotherapy, which is a pretty large number. That is 10.7 million patients. Of those 10.7 million patients, about 7 in 10 go on to develop moderate to severe neuropathy of some form. Of that 7.5 million patients, a little over 40% actually go on to develop painful or severely painful neuropathy. That is the group of patients we are looking to treat. Right now, there are 3 million people in the U.S. that qualify for this particular diagnosis. A very large opportunity, I think you will agree. Unfortunately, this big problem gets even bigger. As time goes on, we are increasing cancer diagnoses. Each year, in fact, estimates are that there is 2 million newly diagnosed cancer patients in the U.S.

If we run through those same filters of those treated with chemotherapy, those who develop moderate to severe neuropathy, and those who have painful or severely painful neuropathy as their dominant symptom, we are seeing an increase of over 330,000 patients each year added to the already existing 3 million patients. This is a very large opportunity, which gets larger. Just forecasting to the future based on rough timelines, if we were to launch Halneuron in 2030 or 2031, we are talking about 4 million people here just in the U.S. who are suffering from CINP of moderate to severe variety. The global incidence of CINP is about 10x that of the U.S. So if you think of 3 million patients here in the U.S. today, that is roughly 30 million people worldwide who are potential candidates for Halneuron therapy based on their own specific journey.