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  Title	OTC Markets Hosts Virtual Investor Presentation with Stacy Lindborg, President, CEO, and Board Director of Imunon, and David Bautz, PhD, Senior Analyst at Zacks SCR
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  Published Date	June 25, 2025, 4:50 a.m.
  Summary	OTC Markets Hosts Virtual Investor Presentation with Stacy Lindborg, President, CEO, and Board Director of Imunon, and David Bautz, PhD, Senior Analyst at Zacks SCR Zacks Small Cap Research Wed, Jun 2
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  Content	OTC Markets Hosts Virtual Investor Presentation with Stacy Lindborg, President, CEO, and Board Director of Imunon, and David Bautz, PhD, Senior Analyst at Zacks SCR Zacks Small Cap Research Wed, Jun 25, 2025, 2:50 AM 26 min read In This Article: IMNN -5.85% NASDAQ:IMNN John Viglotti: Hello, and welcome to Virtual Investor Conferences on behalf of the Life Science Investor Forum and our co-host, Zacks Small Cap Research. We're very pleased you joined us for our quarterly conference. Our next presentation is from Imunon . Please note, you may submit questions for the presenter in the box that are left of the slides. And you can view a company's availability for one-on-one meetings by clicking Book Meeting in the top toolbar. At this point, I'm very pleased to welcome Stacy Lindborg. She's the president, chief Executive officer, and board director of Imunon and David Bautz. David is a senior analyst with Zacks Small Cap Research. Imunon trades on NASDAQ under the symbol IMNN. Welcome, Stacy and David. Stacy Lindborg: Thank you, John. It's a pleasure to be here and to represent Imunon and to give you some insights into what we have going on right now. A lot of excitement. In fact, our daily trading of our ticker IMNN, as you can see on our slide, has had extremely high volumes over the last few weeks, with 3/4 of a billion shares traded in a single day. So, I anticipate there are investors who could be new to our story on this call. SL: So, I'd like to start with an overview of our two novel platforms, which are both in clinical development. So, these are DNA-based products that are in our pipeline. The first technology in our lead technology is TheraPlas. You can see it in the teal on the left side. We've started phase three trial with our lead product, IMNN-001, and we're targeting women with advanced ovarian cancer, which is a disease that is almost always fatal, is diagnosed in 80% of women in late stage, stage 3 or 4, and it does carry around 20,000 new diagnosis a year in the US and around 300,000 in the world. It is a devastating disease, very high unmet need, and the standard of care remains largely unchanged for 25 years. Our phase two data that I'll be walking you through today suggest that we will transform the standard of care if we replicate these findings in phase three. We've an experienced management team and talented staff, which resulted in the ability to take high-quality phase three plans and go through a very smooth review process with the FDA which includes not only elements of our phase three trial design, but also the strategic decision to remove to move the manufacturing of active pharmaceutical ingredient for IMNN-001 inside our labs, inside our clinical G&P labs from an outside vendor, which carries real benefits not only to the cost of our phase three trial, but also really an advantage in the cost of product sold assumptions in the commercial setting. So, from a competitive landscape perspective, it's also important for you to understand that when we look at the frontline indication which we're targeting, you can see all four of the trials that are represented on this slide, two of which have been completed and two are ongoing. We are the only trial that is enrolling patients in this frontline indication, which means that we really have a very high expectation of a high capture rate, as women are diagnosed. Story Continues SL: The second technology, which is in purple, is a derivative of TheraPlas. It's called PlaCCine. It's a novel vaccine platform that you may recall for those who have been following us. We have decided and communicated very clearly that the advancement of this product will be done through partnership, and we are not going to use internal resources to advance this product at this time. We have had some exciting data. In fact, we have just learned we'll have an oral presentation in November at the International Conference of Vaccine R&D here in Boston, and we'll share that we have observed 6-month durability data. So, this platform really offers an opportunity for non-dilutive funding, and in the process, we expect to have the ability to contribute significantly to advances in the vaccine world. SL: So, what is IMNN-001? IMNN-001 is an experimental immunotherapy and gene therapy. The gene delivery system comprises a DNA plasmid, which is encoding the with the IL-12 gene. I'll speak a little bit about that gene in case you're not familiar with it. It's enclosed. This plasmid is enclosed in a synthetic carrier, a lipopolymer, that facilitates the delivery of that plasmid into the nucleus of cells. What is incredibly powerful is that our product, this novel product, is administered directly into the peritoneal cavity, which is where the cancer burden that these women are fighting exists. So, in doing so, IMNN-001 is able to modify the tumor microenvironment through local production, which translates into a safe production of durable levels of IL-12. I'll be sharing those levels with you, but this becomes a powerful anti-cancer immune agent. So it is critical that these are expressed locally. They exhibit multiple fold-dependent increases, which I will provide a viewpoint to in just a minute. And we know that IL-12 really recruits the entirety of the immune system that's being put to work against cancer. SL: So, IL-12, and really the dawn of immunotherapy, if you go back to the 1980s, actually, the discovery of IL-12 really put the role of immunotherapies as a cancer-fighting tool into motion. And the reference that's on the bottom of the side, I note that there's one missing, but there was an article that was published in 2010, which showed that T cells that are engineered to express IL-12 dramatically improved the anti-cancer fighting activity of T cells. And this has become really a very well-established mechanism of action. And when we looked at the activity in the pharmaceutical world, we saw a very rapid pace of trials that were started. So about 40 clinical trials were conducted in the early 2000s. And what we know from those experiences is that dosing IL-12 proved to be a challenge for drug development. And in fact, the administration of IL-12 was being done systemically, administered IV, and all of these products experienced those limiting toxicity, toxicities primarily in the liver and bone marrow, some of which were severe. And we saw an adverse of interest that we have tracked very closely that now is referred to as cytokine release syndrome. IMNN-001, using a plasma DNA administered directly into the microtumor environment, has proven to really be a game changer in this desire to harness this really powerful gene. And certainly, we know that because of the setting of ovarian cancer, which is highly immunostimulatory, we know that IL-12 really is an ideal candidate for a tumor immunotherapy. But knowing how to deliver it really has proven to be the key. And this is precisely the area where we have pioneered. SL: Unlike the fate of these earlier trials that I was describing, we now have phase two data in house and delivered, and we've been able to see that in this phase two trial, we've observed a highly favorable benefit risk profile in the clinic. And it's important to highlight the safety findings that we've observed, especially in the context of these historical trials. So, the key observations you can see on the side, we did not observe systemic dose-limiting toxicities, unlike these historic trials. We have not observed this key adverse event, which is the cytokine release, did not occur with IMNN-001. We have not seen the elevation of immune-related adverse events, and we've also seen adverse events that, frankly, physicians are accustomed to managing with the routine standard of care in chemotherapy. These are common side effects. So, the safety profile and especially in the context of the efficacy, which I'll be showing, has proven to be a very highly, highly favorable balance. From our translational data, we've observed durable local secretion of IL-12. And if you look on the right side of the slide, we're looking at two different cytokines, IL-12, which, of course, is the important payload that we're wanting to see delivered locally. Then we see interferon gamma, that's below. And if you focus first on the teal bars, you can see that local secretion that we're observing after treatment with IMNN-001 occurring, and if you compare the teal bars to the blue bars, what that tells us is: there is not systemic administration. So, the difference of the levels in ascites, which is in the peritoneum versus blood. So that's very important, and it's very consistent with the safety profile that we've observed. We also see that we have a dose-dependent response in IL-12 and interferon gamma, in addition to many other important cytokines that we published. So, while we look at this and we see that we have not hit any dose-limiting toxicities from a safety perspective, the data from phase two that you can see at the far right of the slide, this was the highest dose. This is the dose that we studied in phase two, and we will be taking it into Phase 3. When we look biologically at the response, it seems that we might be at a plateau in terms of the biological response. So, we're very excited by the evidence that we're seeing, and we know from the clinical data that I will that I will share in an upcoming slide that we have fundamentally changed the micro tumor environment. SL: So, I mentioned that ovarian cancer is characterized by a prevalence of a highly immunosuppressive tumor environment, which really does make immunotherapy an attractive approach. And thus far, I focused on IL-12 and the development history specifically with this mechanism of action, but it's important to broaden and to really think about immunotherapies more broadly. So, we know that there have been numerous attempts at frontline approaches using immune checkpoint inhibitors. In fact, when we look at recent press releases, there were press releases at the end of last year and new data that were shown at the Society of Gynecological Oncology and also at ASCO trials such as the Key LINK trial, the first trial, which are attempts at employing immune checkpoint inhibitors in this frontline newly diagnosed patient population. And what we've observed consistently across these attempts to bring immune checkpoint inhibitors that have been successful in other settings, other cancer settings, have not been successful in ovarian cancer. What I mean by that is while we've seen progression-free survival with the endpoint of progression-free survival being hit in these trials, there has been no overall survival improvement. And as the data has been shared in greater detail than just the press releases, we know that there's not even a trend of a response from an overall survival endpoint. SL: So, turning to the slide, I've touched previously on two really important cytokines, IL-12 and interferon gamma. These have both been extensively published, and we know they are central to mounting a really strong immune response against pathogens and cancer. Unlike immune checkpoint inhibitors, where we're going after a damaged DNA pathway, with IMNN-001 and really by leveraging an IL-12 mechanism of action, we're employing a multifaceted approach, which is really critical and that really results, as we'll see in the efficacy data of inducing an anti-cancer immunity through these mechanisms. So specifically, through activation of the immune system, both innate immunity and also acquired immunity, we're shifting, we observe a shift in the tumor microenvironment, which turns cold tumors into hot tumors, the cellular response that we see is anti-angiogenic, which leads to an inhibition of cancer growth and regression. And what we've observed, our clinical data shows evidence of this. We've observed a 13-month improvement in overall survival over the standard of care, which is chemotherapy. SL: The trial design for phase two: we have a randomized trial design, which is taking the current standard of care, which has been the standard of care for the last 25 years, it involves chemotherapy, a combination of chemotherapy, and before and after surgery. So, we refer to that as neoadjuvant chemotherapy followed by surgery, which is reducing the cancer burden through surgery, shrinking the tumors through chemotherapy, and then following the same course after surgery. The experimental arm adds IMNN-001 to the standard of care, and it allows us to really be able to assess very acutely and very cleanly what the advantages of this experimental immunotherapy added to the course that were already following as patients are treated. SL: You can see the endpoints that we studied in this trial. Primary was safety and progression-free survival, leading into the planning of phase three. Also, a very critical endpoint, overall survival, as this has been the place where immune therapies have not been successful in any drug development thus far. So, this is really critical data, and you see other endpoints, and of course, as is common in phase two trials, the study wasn't powered to reach statistical significance. We all understand that the ability for P values to get increasingly small is impacted by the sample size, and we're now seeking to confirm these findings in phase three. SL: So, turning to the endpoints which are recognized by the FDA as registration endpoints, we see a clinically meaningful response observed in the trial focusing on these two most important endpoints. So, progression-free survival and overall survival. We'll start with the top half of the slide, the intent to treat population, which is the full trial; it's an all-comers population. And you can see there are advantages to treatment with IMNN-001, one on both endpoints relative to the standard of care. So IMNN is the blue line, and the standard of care chemotherapy is the red line. If you look at the hazard ratios and the differential in terms of difference in time to median PFS and OS, we see a three-month differential in PFS in this all-comers trial. In the overall survival, we see a 13-month advantage and overall survival. So, what that means, I just want to pause for just a minute. It's easy to look at these numbers and really not internalize that. But what that means is that women who were treated with IMNN-001 on top of the standard of care live for longer than a year, so more than a year than those that received the standard of care alone. SL: So, if we look at the bottom part of this slide, we're focusing on a subset of women who receive PARP inhibitors. This is about 40% of the trial, and that's what we would have expected based on the practice and the treatments with PARP inhibitors. We know that women that have BRCA mutations and other HR deficiencies are often treated with PARP inhibitors as part of maintenance therapy as standard of care. And what we see here is that in the subgroup, progression-free survival, the hazard ratio was fairly similar to the full population, but we see a staggering drop in the hazard ratio with overall survival. So, the hazard ratio went from 0.69 and the all-comers population down to 0.38. The median overall survival, importantly, has not been observed in the IMNN-001 arm, which means that half of the women in this arm are still living. And we see the median has been reached in the standard of care arm, and that was at 37.1 months. So, this is a remarkable overall survival benefit, and it's a result that played a central role in the design of the phase three trial. SL: Another aspect of ovation to data that is quite remarkable is the consistency of the results and, this plot, which is common, it allows for really, an efficient understanding of all the results, carries all of the clinical trial endpoints that were in OVATION 2, and also within these two very important endpoints of overall survival and progression free survival, we're sharing the pre-specified subgroups such that we're capturing all patients in these subgroups. So, before, I showed you the HRD, the women who were treated with PARP inhibitors, I also want to show you these women who did not receive PARP inhibitors. Similarly, we often look at baseline characteristics, so women that have BRCA mutations or other HRD mutations, which really end up with an HRD positive diagnosis, then with those that are HR proficient. In the upper part of the slide, we're focusing on endpoints that are using time to event so that they're comparable. The bottom half has the remaining clinical endpoints. And really, at the end of the day, what's powerful behind these four spots is that you have this dotted line, and everything that's to the left of this line shows that we saw a result that favors IMNN-001. And of course, you can see that across all subgroups and all clinical endpoints, we're seeing an advantage, a benefit, a clinical benefit, as measured by these endpoints in IMNN-001. SL: The importance of these data to the medical community resulted in two very recent events. And I think they speak volumes to how the medical community is receiving this data and their eager anticipation for phase three. So, the importance, we were first offered an invitation to present an oral presentation at the 2025 ASCO meeting, which took place just last week. It's highly unusual for a phase two trial to have a podium presentation at this preeminent conference. The talk was delivered by Dr. Premal Thaker. She's our study PI from phase two and will continue in the same role in phase three. And she presented to a packed audience on the last day of the conference. By the way, the slides are available from this on our website under the News and Investor tab and under the Scientific presentation folder if you're interested in seeing them. The primary manuscript was also simultaneously published in the Journal of Gynecological Oncology. I have a link included on the slide, but it is also available in the same location as the slides. And this journal, in case you're not familiar with it, is an international peer-reviewed journal that serves as the official publication of the Society of Gynecological Oncology. We targeted this journal because of their prominent position they play in gynecological oncology. And if you look at their impact factor, it really suggests a very strong influence in the field. And they're ranking, amongst journals, they're in the top 10% of all obstetrics and gynecological journals, and they're in the top third of all oncology journals. And I have to say that the strength of data resulted in an accelerated review and acceptance, unlike anything I've seen in 30 years of my career. And it is a true honor for us to be published in this journal. SL: So often when I'm talking to investors, there are questions about the similarity between phase three and phase two. Phase 3 is a confirmatory trial, which obviously implies that there are a lot of similarities. I thought I would summarize the trial in this way to allow you to understand the places where there are enhancements and then others that are really remaining the same. So, as you can see from the left-hand side, we have many aspects, including the same dose, the same study schema, the treatment protocol, the control arm, the inclusion criteria, all remain the same as we conducted in the OVATION 2 trial compared to the Phase 3, OVATION 3 study. There are some really important enhancements to the phase three trial. Number one, overall survival is the definitive regulatory endpoint. It is an expectation for approval that you're extending the life of women, and it's obviously the endpoint that patients care about. It's also an endpoint required by European regulators. We expect that by having overall survival as the primary endpoint that if this study is successful, we can expect approval in Europe based on this trial. We've chosen to stratify this trial rather than simply relying on randomization and the effect of randomization. We will be stratifying by the stage of cancer outcomes we know are worse as you get to later stages of cancer. And if you had an imbalance, for example, in stage 4, you can control that through stratification as well as through biomarker information that we're stratifying by. This trial I've also referenced is employing A biomarker strategy that is well understood in cancer broadly and also in terms of ovarian cancer and the impact that this biomarker can have not only on outcomes but also in terms of the disease. So, we know from literature, there was a great study done by MIT that suggests that when we incorporate biomarkers into the fundamental aspects of the design as we are, this increases the probability of success. So, this paper actually suggested that this could be increased as high as 40% by including biomarkers, and we know this will have a big effect on our trial. SL: Other enhancements include, as we actually implemented in phase two, prophylactic pain regimen upfront as part of the protocol. We have quality of life scales that we know will be important for pricing and reimbursement that have been added, and we've defined the maintenance therapy. Again, all of these instances, these enhancements, are really bringing a consistency so that when we're looking at the results, we know that the differences in the treatment effect that we're expecting to see are due to the treatment and not some underlying imbalance. So, this trial is set up to initially focus on an HRD-positive subgroup is the initial cohort. This is the highest probability subgroup and enables early stopping for success with positive results, and what will result in a simultaneous fast track submission for full approval. SL: So, in summary, the potential for IMNN-001 to be a breakthrough for patients with ovarian cancer, we believe, is extremely high. When we think about the treatment landscape and the attempts at using immunotherapy, employing immunotherapy in ovarian cancer, we know that these approaches have not been successful, and therefore, we expect IMNN-001 to have the potential to be the first and perhaps only immunotherapy in ovarian cancer. The view of the breakthrough is really based on the strength of the data and the knowledge that we have not seen any trial deliver an overall survival benefit and a consistency of results across the endpoints, and everything that we measured in the OVATION 2 study, including translational data, in addition to the clinical endpoints. In the setting, we saw a 13-month improvement in overall survival with an even greater differentiation in patients who received PARP inhibitors. SL: The phase three trial is FDA approved, and we are actively working and enrolling patients who will be treated with IMNN-001. Again, I noted that in this trial they will be treated with product that was manufactured inside of Imunon's clinical GMP facility, which is contributing to the cost benefit of this trial. So, in short, this is a phenomenal point in time for an investment in a promising therapy of IMNN-001. And with that, David, if you would like to join our Q&A? David Bautz: Hey, Stacy, can you hear me? SL: I can. DB: Excellent. All right. So, I wanted to start, first of all, with the results that you presented at ASCO. If I'm not mistaken, that was the first time those results have been presented at a major medical conference. So, how were they received? What kind of feedback did you get from physicians? SL: It's a great question, and you're spot on. When we read out trials, you have to look at the abstract deadlines and where it falls relative to these major, major conferences. So, this really was a very important conference as goes the preeminent oncology conference, and it was a phenomenal setting to really be on a platform presenting. The talk was presented in the session that Doctor Thacker presented, and there were three presentations and there was a panel discussion, and we were able to then take live Q&A much like we're doing today. And it was really interesting. So, we got a couple of questions directed to us, including a comment that was reflecting from a clinical perspective of the importance of this advancement. So, there was a comment from a physician that said this is a true milestone for ovarian cancer and for immunotherapies for ovarian cancer, and really reflecting on the importance for patients, which we were delighted for that perspective to be shared. We were also approached in the meeting hall and following through email with MDs that are expressing interest as being PIs everywhere from Hawaii to countries in Europe to even Japan. So, I really think we could not have expected a better reception. DB: That's great. And as far as the phase three trial goes, what is the next update that we can expect from the company? And do you have any estimate now for how long that trial is going to take or when the first interim analysis might take place? SL: Yes. So, we've shared that we initiated the first site. We have a couple of sites and have been initiated, and the next update will be the first patient visit, the first patient that is actually randomized and treated. Our corporate goal is for that to be in this quarter, so in this month. We're working really hard to make that happen. Of course, what we really care about is the last patient visit, which is, I think, where your question really goes, David. The ramp is important, and our target of site activation and getting 15 sites at a minimum up and running this year is very important to us. What you can expect in terms of timing, so we have a base case associated with our enrollment assumptions, and the first interim we're expecting will occur about a year to a year and a half after the full year role trial. So, we'll be all hands on deck working on getting women in. And I think one of the aspects that we have to reflect on when you're going after a newly diagnosed population, as we are unlike in other tumors or other cancers or other diseases where you can tap into a set of established patients in an area and really ramp up enrollment, we're waiting for women who are just now receiving this diagnosis and will be coming straight in into our trials. So, the timing of the first patient visit, we will see the uptick, I'm confident of this, but the first one is just a little bit uncertain, as these sites ultimately are waiting for women to get what we know is a rather sobering diagnosis. DB: OK. And kind of related to the phase three, you talked a little bit a little bit about manufacturing. You have all that in-house. Maybe you can talk a little bit about why that's so important as you run this phase three trial. SL: Yeah, before I stepped into my role as President and CEO, I was on the board, and we were observing over time, when you license in and buy in the core ingredients, the active pharmaceutical ingredients, so the DNA plasmid, the PPC which is the synthetic carrier, we were seeing kind of an exponentially increasing price associated with those, which of course at the end of the day, when we seek to produce a product that is really appropriate we're able to price it at a manner that allows it to get in the hands of all the women that will need this around the world. It also could become cost-prohibitive even in the R&D undertaking. So, our ability to have a phase three trial with the price tag that's associated with it really is quite staggering. And it's because of that ability to manage these costs, but also with high quality. SL: So, we actually did some work early on to compare taking that were produced outside the company and then to look at our processing right to get it ready for treatment. Our yields were consistently higher than the vendors that we were in licensing this for. So, you're talking about greater yields; we know the quality, we don't have to compete with timelines and other priorities, which CDMOs, of course, will, and then the price tag. So, there are many reasons, and we're really delighted that now this trial will have the active pharmaceutical ingredient fully, the FDA has given a green light for patients to be treated with product coming out of our labs. DB: Alright, that sounds great. So, following the recently completed PIPE, curious what the company's strategy is going forward as far as financing goes? SL: Yes, so in our most recent financing, we have warrants which we expect will be we fully expect will be exercised and could generate up to nine and three-quarters million gross proceeds. These warrants were announced as part of the last financing, and we fully believe that they're reflected in the current share price. But that will, when we ultimately think about the close to 10 million in gross proceeds, when you reflect on the cost— which we've shared in the public domain of our trial—this amount really takes us very far, it extends us and, and gives us cash runway even with this alone, into the first quarter of next year. So, we're very pleased by the competitive nature of the deal that we closed. If you look at other deals, we're delighted that this was priced at the market and that really could generate a sufficient amount of capital to get us to a transition point. DB: Alright, that sounds good. Well, Stacy, thank you for this overview today, and thank you, everyone, for joining us for the webinar. SL: Thank you, David. It's a pleasure to be here. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks Investment Awareness (ZIA) is a Zacks SCR product. This text is not a verbatim transcript. This transcript has been edited and does not reflect the video-recording exactly. You may find the video recording in its entirety here. Full Disclaimer HERE . View Comments Terms and Privacy Policy Your Privacy Choices CA Privacy Notice More Info Recommended Stories
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