Hello, welcome to the Life Sciences Investor Forum. On behalf of OTC Markets and our co-host, Zacks Small-Cap Research, we are very pleased you've joined us. The next presentation is from Imunon. Their session will be moderated by David Bautz, Senior Equity Analyst with Zacks Small-Cap Research. Please note you may submit questions for the presenter at any time. You can also view a company's availability for one-on-one meetings by clicking "book a meeting." At this point, I am very pleased to welcome Stacy Lindborg, President, Chief Executive Officer, and Board Director of Imunon, which trades on NASDAQ under the symbol IMNN. Welcome, Stacy. Thank you very much. It's a pleasure to be with you. Thank you to Zacks for this introduction and for this opportunity to talk about our exciting work that is ongoing. Let me, with no further ado, move forward. Included in our deck are our disclosures and forward-looking statements. When we ultimately step back and reflect on the opportunity from an investment thesis perspective, I would say that we have an incredibly strong thesis that I'll be walking through in terms of the framing and then also the background, and ultimately what stands behind and gives really robust confidence to these points. We're in the middle of a registration trial, which will be a frontline in newly diagnosed women with ovarian cancer. The funding opportunity is to enable full funding of this trial. When we step back and think about the context of this product is expected, if we are successful in phase III, it will be a first-in-class immunotherapy in ovarian cancer. There are no immunotherapy agents that have been successful, and we'll talk a little bit about why that is and why we have the evidence that we should be the first that would be approved in immunotherapy. It would also be a first-in-class IL-12 immunotherapy, which is another conversation that I think is really important that we'll dive into in some subsequent slides. Basically, there has been no change to the standard of care. Whether you care about the mechanism and how the product is working, the frontline ovarian space, the standard of care has remained unchanged for almost three decades. We're talking about changing the lives of women with ovarian cancer, compelling data that we have generated from a very large, well-controlled phase II trial, which allows very simple interpretation because we've actually taken patients and randomized them to receive the standard of care, which is neoadjuvant and adjuvant chemotherapy with surgery that basically is removing the cancer in between those two treatment periods with chemo. Then half of the patients were randomized to that arm, then the remaining half were randomized to receive that standard of care plus Imunon. When we compare the treatment arms, we know that this allows us to really understand and appreciate what's different between these treatment arms as a result of the novel experimental treatment. We know that this data is very strong and is unprecedented. We also know that because of this represents a multi-billion dollar unmet medical need. This is something that's true with just the frontline indication, the first indication that we're going after with ovarian cancer. We know that also we believe that there is rich and broad application of this product, and then further to the technology platform that could go after other indications. What I'm really painting is the smallest entry-level opportunity, and what we would expect would be peak revenue sales for frontline in really the U.S. is already a multi-billion dollar opportunity. We know that we're very aligned with FDA on top of the advancement of our trial. FDA granted Fast Track. We have orphan drug status in the U.S. and Europe, and we have brought in and really cultivated incredible skills within the company that ultimately will be incredibly important when we get to the commercial market. Namely, very specifically, one of those skills and capabilities is the clinical-grade GMP suite that we have in Huntsville, Alabama. We are manufacturing the core API, the active pharmaceutical ingredient for this product, and it allows us to keep cost amazingly in check. Ultimately, when we get to the commercial setting, to be able to produce product in-house with robust gross margins. You'll hear over the course of my slides that we have a really strong alignment with FDA, including already knowing and agreed upon potency assay. What this really sets us up for is replicating findings that we've already observed in phase II, and a very strong phase II that has really taken a lot of interest by the medical community. We're actively advancing this. We have the definitive endpoint, which allows for a confidence in a single study filing. On top of that, we do have, as we've discussed before, a protocol that, with FDA's blessing, has two interim analyses that could allow for even earlier stopping and full approval. Let me go through just some background in case you're new to our story. What is IMNN-001? What is our technology platform? Why ovarian cancer as our first indication to go after? Number one, if you look in the literature, you'll see that immunotherapy has always, those that develop them and from a market standpoint, has looked to epithelial ovarian cancer as a really highly valued target because the disease itself is immunologically cold. When we reflect on ovarian cancer, effectively it's evading our immune system, the natural defense that we have. Therefore, if you can tap into the immune system and alter the tumor microenvironment, you would have an ability to then harness the immune system, therefore making an immunotherapy very attractive. Our product is a IL-12 DNA-based plasmid. It is encoded with IL-12, so we're not administering IL-12, we're administering a product that basically is carried through a synthetic nanoparticle, a lipopolymer that allows our novel therapy to go directly, it's administered directly into the peritoneal cavity, which is exactly where the tumor is residing. The cells in the peritoneal cavity uptake the novel product, and these cells start producing IL-12. We're not delivering IL-12, we're effectively delivering a recipe, and the body is then able to take over and produce this naturally occurring cytokine that is very effective and very well understood. IL-12 and immunotherapy, the IL-12 that we are producing, what we call IMNN-001, really is renewing this promise for ovarian cancer survival. In fact, when we reflect on the approaches, this has been such an incredibly sought-after and really highly thought of in terms of being able to really revolutionize the standard of care. Why do we believe IMNN-001 will result in a different approach? I would say for multiple reasons. Number 1, when we look back over the last 25 years, the reasons products have not been successful in going forward is they were administering IL-12, recombinant IL-12 directly intravenously, so IV, which resulted in safety side effects, and those safety side effects in some instances didn't allow them to actually titrate up to effective doses. What is very different, again, about IMNN-001 is it's going directly into the peritoneal cavity, and I'll show you data that conclusively we know that the product that is stimulating higher levels of IL-12, it's not systemically being distributed. It's staying in the peritoneal cavity. We have an ability, and we know that the dose is effective because when we look at our clinical data, we see something that no product, not just relying on immunotherapies, but there's been no product that's ever been able to show an overall survival benefit. We have an unprecedented clinical effect. We have the ability to look at our biological response, which I'll show you in just a second, and we also can measure levels systemically being distributed, and we see that we do not have an elevation. Fundamentally, we've overcome the challenges that stopped previous attempts, and we've been able to generate evidence that shows that this is an incredibly, very strong platform, that we have incredibly high hopes and, I would say, estimates from a probability standpoint of this being an effective treatment that we want to deliver in phase III for approval. I mentioned before that ovarian cancer is the first indication that we chose to go after. We've done actually quite a bit of animal research, discovery work in other indications. This is actually a very small representation of the studies that we've done, but it's meant to really illustrate that there are very attractive targets, including pancreatic cancer, colorectal cancer, bladder cancer, glioblastoma. You can see there are different routes of delivery that we could consider, and even, you note on here, combination with immune checkpoint inhibitors. This is something that gains a lot of interest in our conversations. We know that immune checkpoint inhibitors have been very effective in other cancers, yet have failed in ovarian cancer. The effect that we are having in the tumor microenvironment may in fact allow for a bigger effect and a synergistic effect with a combination therapy. That is definitely an area that would be of interest for future research. We know the unmet need is high. This is, again, with no change to the standard of care in over 3 decades. We also know that the concern with this specific cancer is that women, the symptoms are so nondescript that 80% of diagnoses in women that have ovarian cancer don't come until the cancer is already in late stage, so stage 3 or 4. That really stacks the card against these treating physicians and the women who are fighting this disease, and unfortunately means that we see that only 40% or less will make it to five years after their diagnosis. We know that even of the cases, so if you take in the U.S., there's about 20,000 new cases every year, very consistent, 13,000 deaths. We know that even of those that respond to chemotherapy, to the frontline chemotherapy, and have the best response possible, almost 70% will recur. It really is critical that we're making advances, and this really puts IMNN-001 in a very, very important role and a place where we would expect if we replicate what we've shown in a large phase II trial, in phase III, we would expect to revolutionize the standard of care. This just goes into a little bit of the data that I'll be showing you. Again, no frontline cancer trial has been able to show an overall survival improvement until our phase II trial that I'll show you. We're up now. The final readout of our OVATION 2 study showed almost 15 months over the standard of care. The median was prolonged, and we're talking well over a year women were living over those that only received chemotherapy. The ability for this to truly transform the standard of care, I think, is very well understood. You can see in the third strike here, the third bar, the 14.7 months, and I'll show you this data in just a minute. Of course, the knowledge that we are actively enrolling in our phase III trial. FDA is fully aligned with our plans and, in fact, we're continuing to beat the enrollment projections in our forecast internally. We're on a track to, with each passing month, to be getting closer to the end of the trial. It's very important that we continue with this acceleration. A big part of this is really being driven by the fact of the magnitude of the effect that we've observed. This is carrying an enormous response by the medical community. On the safety front, it's always important to talk about benefit-risk. I've been talking about efficacy, but the benefit-risk is incredibly favorable. It's a very highly favorable benefit-risk profile. If we talk about the largest study that we've done, but the comments I'll make are cumulative across all of our exposures, all of our treatments, we have not seen systemic dose-limiting toxicities, and we were watching very closely for the side effects that were seen through IV administration of IL-12. They weren't observed. An adverse event of special interest that we were monitoring for, cytokine release syndrome, did not occur with IMNN-001. We've not had elevation of immune-related adverse events. Really, the common treatment adverse events you see here are managed and our principal investigators are very accustomed to, as many of these are associated with the chemotherapy that's been given in combination with IMNN-001. Getting into first the biological response, because when you ultimately look at clinical data, it's really, I think, helpful to step back and say, "Okay, what's happening in the tumor microenvironment, and do we know what's actually causing this extension in overall survival?" In our case, we do. We see that the product is working exactly as intended. You'll note that really, as we go across a couple of slides, and these are published data, we have more extensive data, but you'll see that we really are fundamentally altering the tumor microenvironment. When we start to look at individual biomarkers that are of interest and are very important, we can see that IMNN-001 is not simply resulting in a high level of IL-12, and that certainly is happening. I'm going to go to the next slide so you can see that as we look across on the right, we see the doses from 36 up to 100. It's very clear we have an exponentially increasing level, fold change of IL-12 at the highest dose, which is what we are studying in Phase III, compared to the lower dose. What is exciting, though, if this were a simplistic response of IL-12, we would not see movements that really are showing that we are having a cascade of effects and that our product is actually having an influence on both of the major arms of the immune system, both the innate and adaptive immunity. We see this fundamental decrease in immunosuppressive biomarkers, which, as I said before, is a hallmark of the cancer itself. It's one of the problems why our bodies are constrained from being able to appropriately attack this cancer on its own. Again, I've already spoken about the potential for this in a future set of studies. This could open up combination therapy that really could be very fruitful as we look down the path for patients fighting this disease. There are two other points I want to make on this slide. Number one, interferon gamma is the potency assay that FDA has already approved that we could use in the commercial domain. If the product's approved, interferon gamma would be our potency assay. You can see that we have the same Really high elevation. At 100 milligrams, we're above 60, a 60-fold change from baseline. We have this substantial effect, and interferon gamma on its own is critical. One of the things I want you to look at in both of these graphs are we're focusing on the teal bars, but if you look at the dark blue bars, this is the critical point from a safety standpoint, that as we were increasing dose, you can see that the systemic distribution. If we measure IL-12 and interferon gamma and many other molecules, we would be able to see that, in fact, it is being contained to the peritoneal cavity. The drug is actually in the compartment where the cancer is. That's exactly where we want it. The safety profile that we see, we really do believe is largely driven by the fact that there is no systemic distribution. This is a very effective result, and in fact, it shows that the product, what is actually causing now the clinical data that we're very excited by. I described before a 15-month, 14.7 to be precise, difference in the median overall survival. You'll remember if you've followed us for a while, if you're new to it, when we first looked at the data from this study, we had an 11-month difference in the medians. We continued to monitor and observe overall survival, and we now have closed the trial, and we've ended with again, an unprecedented, but an even larger effect of close to 15 months. You can see how we get to that. Women that were treated with the standard of care plus Imunon, the median overall survival was 45 months. For those only receiving chemotherapy, it was 30 months. We're talking over a year, a substantial amount of life, that these women get to experience, and ultimately from a very short treatment course. What we're studying is consistent with phase II, and we're excited ultimately down the path to be able to explore what further and longer treatments would be. This is the course that we would go after for registration trial. You can see the effect in all comers. The next slide goes through women that receive PARP inhibitors. On both treatment arms, we know that women were receiving the treatments that they were randomized to, and then this shows if they received PARP treatment on top of that. You can see that previously we had not yet reached the medians. That meant that in both treatment arms, that we still had more than half of the women still alive in the trial. We now have reached a mature study endpoint for this subgroup, and you can see that we have a 24-month difference. Women with Imunon treatment are living on average two years longer. This is one metric of how excited the medical community was. Last year at ASCO, we were invited to give a platform presentation, and we had immediate, the simultaneous publication of the results in the pre-eminent journal, "Gynecologic Oncology," which has open access. Really I'll wrap up fairly quickly because I want to allow time for Q&A, but this plot is in our manuscript. What's really important, we don't have time to go through all the secondary endpoints and other subgroups, but you can actually see that across every single endpoint and every single subgroup, we observed an Imunon treatment effect in OVATION 2. This is an amazing consistency going back to the biomarker data, what we know is actually happening in the tumor microenvironment, and then ultimately what is coming downstream. This is revolutionary, certainly to ovarian cancer, even more so for immunotherapy. We have a phase II trial ongoing. We can talk about it if you want me to go into further detail, but this is really a very similar, it's a confirmatory trial, so we're implementing a trial that's very consistent with our phase II trial design. I'll close basically with this slide, which is a summary of what I've gone through. Consistency with FDA, full alignment on our plans, which includes the CMC plans and the treatment in the trial, which is coming from our labs. The confidence ultimately in this product is coming from clinical data and the consistency of the data and the ability to enroll it. We have set a forecast that I've talked about openly on our earnings calls. We expect to be at 60 patients by the end of the year, 80 by the end of Q1, and we are 100% on track to meet that. With that, I'll pause and entertain questions. All right. Thanks, Stacy. That was a great overview. There's a couple points that I want to drill down a little bit if we can. The first of which is the use of IL-12. Some of the feedback that I've heard is investors are a little bit skeptical maybe, or nervous about IL-12 given past issues with toxicity with systemic IL-12 treatments. Maybe you can just walk us through what are really the big differences between IMNN-001, and then those previous IL-12 therapies that led to those toxicity concerns. It's a great question, David, and it's an important point. I'd say there really are twofold. Number 1, route of administration is radically different. All of the historic attempts were administering directly into a vein, so IV, which then allowed it to systemically distribute throughout the body. We're taking a catheter, which is implanted just under the skin of women, right in your abdomen, and it allows for direct injections into that catheter over the course of our trial, and it stays, as we showed, our product is actually delivered exactly where we want it. Route of administration is number 1. The side effects that were coming because of the systemic distribution didn't allow some products to even titrate up to effective doses. They also had significant safety findings. Again, the route of administration is at the heart of it. We're fundamentally also different in that we're not delivering IL-12. Our vials do not contain IL-12. They contain, effectively, a recipe, which is allowing our body to produce this cytokine, which all of us, this protein that we all have. As you see, there's a cascade that's incredibly effective. It's igniting the immune system, and it's working very well. All right. Thanks for that. The other thing I wanted to drill down into was the interim analyses that you talked about with the deaths that are planned in the OVATION 3 trial. What exactly will those interim analyses be looking at, and then what are the potential outcomes of those interim analyses? The way the protocol was designed and aligned with the FDA, you ultimately look at, this is a fatal illness that we've seen enormous unmet need and no change to the standard of care. Companies like Imunon always have an urgency. If we have an effective treatment, we want to move beyond treating women in the trial as quickly as we can get it in the hands of women that are fighting for their lives. The strategy with the interim analyses was to allow for an early read on the primary endpoint, fully specified, fully alpha controlled, and fully blessed by the FDA, such that if we were to hit positively, then we would have the ability to file the data at that time for full approval while we continue to monitor and allow the trial. The treatments are going to be long done. We would be just basically observing overall survival. We set up two, and as I've talked about in the past, you choose the earliest time point where you could really have an effect. Obviously, the later you wait, the more likely it is that you hit. We're using a method that is very well understood, and therefore the FDA didn't have any concerns with the methodology. It's called a group sequential trial. We appropriately adjust for Type I error rate. It's actually a very small hit. There's enormous upside. If it hits, you then immediately file, and we would have our application ready, such that it would be a very short timeframe from the data monitoring committee looking at the data, triggering an early submission, and then the filing. If the first interim is not successful and there's more time that's needed, at the end of the day, we've designed a trial to be very effectively powered. We would continue to the timing of the second interim. The timing of those are based around events or deaths, so they're event driven. If we have success at that second, the same thing would happen that I described before. If we're not, we would go to the end of the trial. What we see through, we've done lots of clinical trial simulations that basically with each passing time, of course, the probability of success is going up. It's a very well thought out design, but gives a confidence that if we see a bigger effect than we are conservatively assuming, then we will be able to act on it. We've got a couple questions from attendees about partners. As the phase III trial has been progressing, have you seen any more interest from big pharma, larger company partners, and how are you thinking about partnering, say, in the U.S. versus ex-U.S.? Maybe can give some insight into that. We'll always be open to partnerships that will further our goals, which is to bring forth a transformative treatment, starting with ovarian cancer, and that's in the best interest of our shareholders. We approach conversations from a very open perspective, and we are agnostic as to the geography. In fact, we do have ongoing discussions with a company that is outside the U.S., and we continue to turn, as requests for information come in, we turn things around quickly, and I hope it's something that I have an opportunity to give a formal update on in the future. We'll continue to engage in discussions, and have had and will continue to have conversations with bigger pharma. Right now, I have nothing formal to announce other than we remain engaged and look for opportunities that can propel the company forward. Stacy, thanks for the overview today. We really appreciate it. Thanks for tuning in. I appreciate the opportunity to present this, and really appreciate everybody that has joined into the presentation for the Q&A. We'll make sure we capture it and have a way that we can respond to questions, and I look forward to giving updates in the near future. Thank you very much.