IMNN

Image source: The Motley Fool. Tuesday, Aug. 11, 2026 at 11 a.m. ET President and Chief Executive Officer - Stacy R. Lindborg Chief Medical Officer - Douglas V. Faller Interim Chief Financial Officer - Joshua Blacher Executive Chairman - Michael H. Tardugno Managing Director of Investor Relations - Walter Pinto Operator: Good morning. I will be your conference operator for today. At this time, I would like to welcome everyone to the IMUNON second quarter 26 Financial Results and Business Update Conference Call. I will now turn the call over to Walter Pinto, Managing Director of Investor Relations at KCSA Strategic Communications for introductions. Please go ahead. Thank you, operator, and good morning. Welcome to the IMUNON Second Quarter 26 Financial Results and Business Update Conference Call. Joining us today are Stacy R. Lindborg, President and Chief Executive Officer Doctor. Douglas V. Faller, chief medical officer and Joshua Blacher, chief financial officer. Michael H. Tardugno, the company's Executive Chairman is also on the line for the Q&A portion of today's call. Before we begin, I would like to remind everyone that our remarks today include forward looking statements. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 2 thousand. Include, but are not limited to, statements regarding the timing and enrollment of the company's clinical trials, potential of the company's therapies to address unmet medical needs, the market potential for its product candidates if approved, and the company's plans and expectations for its development programs. Words such as may, will, expect, plan, anticipate, estimate, and intend, identify these forward looking statements actual results may differ materially from those projected. Additional information on the factors that could cause actual results to differ is detailed in Imunon's filings with the Securities and Exchange Commission, which are available at sec.gov. And on the company's website. Forward looking statements made on the call speak only as of today's date, company undertakes no obligation to update them except as required by law. With that, I would now like to turn the call over to Dr. Stacy R. Lindborg. Stacy, please go ahead. Stacy R. Lindborg: Thank you, Walter, and good morning, everyone. Thank you for joining us today and for your continued support of IMUNON. The second quarter marked another period of focused execution and key validation of both IMNN-001, our lead asset, and our TheraPlas Platform. Across our clinical programs, we continue to demonstrate the strength of our data, which is earning growing recognition within the scientific community while remaining disciplined in our execution. Our North Stacy remains unchanged. Bringing a much needed new treatment option to women with ovarian cancer. A disease that affects approximately 300 thousand women worldwide each year, has a 5 year survival rate of roughly 40% and has seen little meaningful advancement in the standard of care for nearly 3 decades. Before we dive into this quarter's progress, I want to invite our investors and members of the media to join us for our R&D Day on September 23 in New York City. We look forward to providing a deeper look at the science, behind IMUNON the progress we have made, and the opportunities that lie ahead. Onto the second quarter, I will begin by highlighting 3 themes that have shaped this quarter. First, the continued validation of our technology and platform, second, the strong pace of enrollment in our pivotal Phase III OVATION III study. And third, the disciplined financial and operational execution across our company as we maintain focus and remain focused on advancing our phase 3 clinical trial. So first up, continued validation of our technology and platform. Turning to the clinical foundation that underpins everything we are doing, the final data from our completed phase 2 OVATION II study, which continues to strengthen our conviction in IMMUN-1. Across successive analyses, we have observed a consistent and clinically meaningful improvement in median overall survival. Most recently, 14.7 months in the intention to treat an all comers population of newly diagnosed patients. This alongside a highly favorable safety and tolerable tolerability profile that successfully addresses the historic barriers associated with systemic IL-12. Complementary translational findings, including lower rates of minimal residual disease, higher circulating tumor DNA clearance, and increased encouraging rates of no evidence of disease, following frontline therapy further reinforce the biological activity of localized durable IL-12 expression at the tumor site. These consistent clinical and translational signals give us high confidence as we advance the pivotal Phase III program. Staying with the first theme and really focusing more on the additional validation that comes through, our phase 2 m MRD or minimal residual disease trial. As a reminder, in July, we reported encouraging preliminary data from this trial. The study is being conducted in collaboration with Breakthrough Cancer and is led by investigators at MD Anderson Cancer Center. The study is designed not only to evaluate clinical activity, but also to better understand how MU9 thousand remodels the tumor immune microenvironment. Following frontline treatment. Among patients who had reached the study's primary assessment and endpoint, a second look laparoscopy treatment with IMNN-001, was associated with a lower rate of MRD positivity compared to the control arm, 44% versus 67%. It was associated with a higher circulating tumor DNA clearance with IMUNON arm 87.5% versus 62% in the control arm. And a higher proportion of patients achieving no evidence of disease following frontline therapy, which was 100% the IMUNON treatment arm versus 56% in the control arm. Now these are preliminary findings from a small cohort, they provide encouraging evidence of deeper antitumor activity for IMNN-001. The translational analyses continue to support IMNN-001's proposed mechanism of action. We observed robust IL-12 expression within macrophages, activation of downstream cytokines, including the FDA endorsed potency assay interferon gamma, We observed evidence of both macrophage and T cell activation consistent with remodeling the tumor microenvironment from an immunologically cold state to 1 that is immunologically active or hot. Finally, these encouraging biological and clinical findings continue to be accompanied by a highly favorable safety profile. Across the MRD study, which is also true more broadly, we have observed no cytokine release syndrome, no systemic toxicities, and no serious immune related adverse events. Further reinforcing our belief that MU901 has successfully overcome the historic safety challenges associated with IL-12 based therapies. Enrollment in Phase III and turning to our lead Phase III asset we remain very encouraged by the continued pace of enrollment in our pivotal OVATION III study. The trial continues to generate strong engagement from investigators and patients, reflecting the strength of the data generated in OVATION II. Which includes a well established safety profile and compelling overall survival and efficacy results. That we believe are unlike anything previously reported in the setting. Operationally, the team has executed with discipline and speed, from protocol finalization through site activation and first patient enrollment, we have moved at a pace meaningfully faster than industry benchmarks for phase 3 study start ups. Enrollment rates are exceeding our internal assumptions, with the majority of activated sites performing at or above plan, This momentum reflects the strength of our data and the enthusiasm of investigators at leading cancer centers. That are involved in our trial Combined with the efficiencies gained from our sharpened organizational focus, and in house manufacturing, we are demonstrating the operational excellence required to advance a late stage program of this importance. With that, I will turn the call over to Dr. Douglas V. Faller, our chief medical officer who can expand on these data and offer perspective on the phase 3 progress in more detail. Douglas V. Faller: Douglas? Thank you, Stacy. As Stacy mentioned, OVATION III is our pivotal phase 3 trial. Evaluating IMNN-001 in combination with standard of care neoadjuvant and adjuvant chemotherapy in patients with newly diagnosed advanced epithelial ovarian cancer. We continue to be very encouraged by the trial's execution and momentum. Site activation has proceeded efficiently and enrollment continues to exceed our planned assumptions. We are currently enrolling approximately 0.5 patients per site per month. Compared with the 0.3 patients per site per month assumed in our trial plan. And compared with historical ovarian cancer study rates, of about 0.2 patients per site per month. From a clinical perspective, we believe this enrollment trend reflects several factors. The encouraging survival and biomarker data generated in the OVATION II study growing familiarity with IMNN-001 among investigators, a high conversion rate from pre screening to randomization, and operational efficiencies that simplify study participation without delaying initiation of standard of care treatment. Equally important the quality of the study remains very strong. Patient compliance with scheduled study visits treatments have been excellent. Electronic case report forms continue to be completed in a timely manner. And the resulting data are supporting the ongoing maturity of the trial database. Finally, and very importantly, the safety profile remains highly favorable and completely consistent with our prior experience. To date, we have observed no cytokine release syndrome, no systemic toxicities, and no serious immune related adverse events. Safety therefore remains comparable of across both treatment arms and a recent schedule independent IDMC, independent data monitoring committee review identified no new safety concerns. These enrollment and safety findings build on the foundation established by OVATION II. Which demonstrated a 14 point 7 month increase in median overall survival 45 point 1 months versus 30 point 4 months. And a 24 point 2 month increase among patients who received ARP inhibitor maintenance. 65 point 6 months versus 41 point 4 months with zero serious immune related adverse events observed. The interim data, survival data, have been published in gynecologic oncology and were presented at the ASCO Annual Meeting in 2025. And we plan to submit the final overall survival data, which I just specified, to a major medical conference and expect to present those findings in early 27. In addition, because of the unique technology of the TheraPlas platform, which enables the safe and efficacious delivery of interleukin-12 to tumors, and thereby solves a decade long barrier We were invited to present at the inaugural AACR drug Discovery and Development Congress the d 3 Congress, in July. Additional emerging translational data fully documenting the ability of IMNN-001 in our clinical studies to effectively reprogram the immunologically cold tumor microenvironment of advanced ovarian cancers into a hot anti tumor environment was just accepted for presentation at the annual society for the Immunotherapy of Cancer SITC, conference in November 2026. Stacy R. Lindborg: I will now hand the call back to Stacy. Thank you, Douglas. I would like to turn briefly to how we are managing the business, because we are managing the business. Because our actions speak to the confidence that we have in IMMUN-1 and the opportunity ahead. Every decision we make is guided by a single priority, advancing our pivotal Phase III OVATION III study as efficiently and thoughtfully as possible. That commitment is also reflected in how the leadership team and employees have chosen to be compensated Leaders across the organization as well as members of their teams have voluntarily elected to receive a meaningful portion of their compensation in equity rather than cash. This is a tangible demonstration of the confidence we have in the program our belief in the long term opportunity, and our alignment with shareholders. At the same time, we remain disciplined stewards of capital carefully allocating resources to maximize the value of our clinical programs while maintaining strong alignment with our investors. On the financing front, in June, we completed a financing of up to $10 million to support the OVATION III clinical program. The structure was designed with our shareholders in mind preferred stock, which is both nonredeemable and nonconvertible, along with secured promissory notes. In this financing, there were no warrants, thus minimizing shareholder dilution and reducing financing overhang. Looking ahead, we will need to continue to strengthen our balance sheet with additional capital to support the full execution of the Phase III trial as well as our DNA needs. We are actively exploring options that maintain the same discipline that I just spoke of. With that, let me turn the call over to Joshua Blacher, our recently joined us as interim CFO to review our financial results. Joshua Blacher: Joshua? Thank you, Stacy, and good morning, everyone. Details of Imunon's second quarter 26 financial results are included in the press release we issued this morning and in our Form 10 Q, which we filed before the market opened this morning. Research and development expenses for the second quarter were $1.5 million compared with $1.2 million for the same period last year. Primarily reflecting higher clinical and manufacturing costs related to the OVATION III study. General and administrative expenses were $1.3 million for the second quarter, down approximately 20% when compared with the $1.6 million in the prior year period. This trend speaks to the ongoing cost containment initiative to which Stacy referred earlier. This remains 1 of the highest priorities for management. Net cash used for operating activities for the second quarter was $3 million down from $4 million used in the first quarter of 26. As of 6/30/2026, we had cash and cash equivalents of $6.9 million Together with the financing we completed in June and our ongoing cost discipline initiatives, we believe this supports an operating runway through the end of the year. With that, I would like to turn the call back to Stacy for closing remarks. Stacy R. Lindborg: Thank you, Joshua. I would like to start with, operator, to open the line for questions. First before my closing remarks. Operator: Thank you. And we will now begin the question and answer session. Reminder, if you would like to ask a question, please press star followed by the number 1 on your telephone keypad to join the queue. If you would like to withdraw your question, simply press 1 again. If you are called upon to ask your question and are listening via loud speaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. And your first question comes from Emily Bodnar from HC Wainwright. Please go ahead. Emily Bodnar: Hi, good morning. This is Joey on for Emily. Congratulations on all the progress and thank you for taking our questions. To start off on the phase 2 MRD trial, you believe that the MRD improvement rates that you have been seeing with IMUNON-001 be sufficient to show statistically significant improvement versus control? And how is this and how important is this numerically higher rate of no evidence? Versus disease versus control? And on top of that, also, when you discussed the September R&D Day coming up, do you plan to disclose any data from the ongoing trials including the MRD trial and the OVATION III? And lastly, for the rapid site activation that you have been discussing, Is this sustainable what is increasing your confidence in this going forward, and is there any adjustment to enrollment timelines that might be quicker than the first half 29 timeline. Stacy R. Lindborg: Great. Thank you. Thanks, Joey, for the questions. Douglas, you want to start with the MRD trial, the question about how the trial was set up and is it likely to reach statistical significance? Douglas V. Faller: Be happy to. MRD trial is a small trial. And we certainly may reach statistical significance. The trial is still ongoing. We are still enrolling patients and still assessing MRD by multiple means at the time when the patients have finished their adjuvant chemotherapy. But because it is a small numerically small trial, whether we reach statistical significance or not, we will have to see as the trial progresses. We think that we will The importance of this trial, I think that was also part of your question. Is that this is another way of showing the increased depth of response that we get by adding IMUNON to standard of care therapy. We have been able to see quite clearly that many of the patients after having neoadjuvant interval debulking surgery and adjuvant therapy, still have disease either macroscopically or microscopically. And we have been able to substantially decrease that by adding IMUNON. Clearly, the emerging field of MRD, as you well know, is a way of determining, for example, whether additional therapy might be used, using it as a prognostic factor. But clearly, when you have completed therapy, having residual disease is not a good thing to have. So the fact that we can decrease, clearly decrease molecularly and microscopically and macroscopically the amount of any disease remaining. Is quite important, I think, prognostically for the patients and completely consistent with the improvements in survival the very impressive improvements in survival that we saw in the OVATION II study. There was 1 other part of your question. I think you were asking are we gonna be talking about MRD in OVATION III We are assessing things like circulating tumor DNA in the in the phase 3 study. But we do not have that data available at this time to discuss at R&D Day. Stacy? Stacy R. Lindborg: Sorry about that. Thank you. Thanks for both. I will offer a few other comments. So in terms of the statistical significance of the MRD trial, it is always important to understand how a trial is was planned. So that trial was the sample size was not determined because of statistical power. So at the end of the day, we know that is 1 influence of the likelihood of a statistically significant finding. This really is an important trial that ultimately is designed to answer some critical questions We will hear Dr. Amir Jazari, who is the national PI, reflecting on the trial at the R&D Day. And if the effect continues to be large, then 1 might see statistical significance, but that was not the goal, as Douglas pointed out. We will be putting out an agenda for the R&D Day and look forward to releasing that in the near future and you will get some greater insight into what we plan to cover. We do think it will be a very, very compelling set of presentations and will allow for interaction with some key experts and clinicians who have been treating patients with IMNN-001 for a couple of decades. Number 3, your question about enrollment, is it sustainable? I would say yes. And a large part of that is the knowledge and experience that we have from OVATION II. And the planning that we have done, including using clinical trial simulations to look at what we would expect in terms of enrollment over time and looking at trial sites, we are very, very carefully activating sites to make sure that we stay ahead and that we are able to complete the enrollment on our target timeline, and we are tracking extremely well to that. So you know, the plan and bringing on new sites really brings new reinforcements and the excitement level that we are continuing to see from the sites that were early in the trial. So we are we are feeling extremely confident, and we will be working closely with these partners to ensure that we are we are delivering this trial as we promised. Emily Bodnar: Great. Thank you for taking our questions, and congratulations again. Operator: Your next question comes from Jason McCarthy from Maxim Group LLC. Please go ahead. Jason McCarthy: Hi. Good morning. Thank you for taking the questions. This is kind of a multipart question all related to the MRD. Stacy, if you would bear with me. So what is the expected timing to complete the smaller MRD study and will the study ultimately or the results be published? Is the gynecologic oncology group or the GOG involved? In any way, or were they potentially becoming involved given that there is currently no MRD standard for ovarian cancer? And following that up, can you discuss a bit about how--the way I see it is that study is kind of breaking new ground in how ovarian cancer could ultimately be managed Thank you, Jason. Stacy R. Lindborg: Those are great questions. So let me start and then Douglas, I will turn it over to you. I know you have spent a lot of time thinking about how this the innovative approaches and really the translational data that we have will help advance the treatment paradigm and really understanding how we can assess and measure the disease. But the expected timing you know, the trial--this is an emerging endpoint. The second look laparoscopy is something that the FDA has expressed interest in. But does require a second procedure with patients. And the trial itself is growing and increasing and we have continued to have discussions with breakthrough cancer and the lead PI. Around the progress of the trial, and we are delighted that we have already accomplished a couple of goals. Number 1, that we know now that IMUNON can be safely treated, administered concomitantly with bevacizumab. That was 1 internal goal that we had and wanted knowledge of. That has already been accomplished. Number 2, is focused on the ability to treat women with IMUNON in the maintenance setting, and we have women that are receiving that are receiving treatment in the maintenance setting. So outside of the questions that you have you have asked relative to this landscape. We are very pleased with those learnings, and we would expect, I would say, you know, as we go through the end of the year, we are expecting and hoping that the trial will reach full enrollment and then there is a timeframe that is required to observe patients. Through second look laparoscopy. But that is the general landscape. The GOG is not involved in any formal way in the MRD trial. We have involved them in our thoughts and plans, strategic inputs, specifically to the phase 3 trial. We had an advisory board with them. And we have DoD sites that are involved in our phase 3 trial. But right now, they have not been integral the plans around the MRD trial. Douglas, would you like to pick up and comment on any of the 3 questions that you would like to add to? Douglas V. Faller: Certainly. Certainly. there is a fast I am sorry. Did you have were you speaking, Jason? No, no, no. I did not say anything. Okay. I heard something. Sorry. With respect to the question, will the MRD data be published? Absolutely. We are in discussions with the principal investigator as to when we will start when he and we will start presenting data from this trial in national forums. Excuse me. The Stacy's comments about GOG I would like to expand them a little bit. Stacy R. Lindborg: Because part of the question, GOG, like everybody taking care of patients with advanced ovarian cancer, is very interested in having a set of guidelines with respect to measurable residual disease This would be very helpful most helpful if we had additional therapies to give to patients. 1 of the hard parts about determining the prognostic abilities of measurable residual disease. The best way to do that is to have a therapy which actually impacts on the outcomes of the patients. And we believe that we did this quite impressively in OVATION II, We improved overall survival. Douglas V. Faller: We believe that we can do this. We certainly hope that we can do this, repeat in OVATION III. And therefore, we would have a population of patients in which we use studies like circulating tumor DNA in a population in which we advanced and improved on overall survival. it is those kind of studies that can validate and make the FDA look at something like circulating tumor DNA as an important prognostic marker. So we hope in OVATION III to be able to contribute to the ongoing work to develop a good MRD assay for ovarian cancer. Jason McCarthy: Thank you. Great. Thanks. And I thought that this question might have been asked and answered about the continued or the potential continuation of the 0.5 patients per site per month rate Is there any seasonality to enrollment for ovarian cancer? Is summer historically a little bit more challenging winter? Are there fluctuations that can change that number? Douglas V. Faller: Douglas, what is your observation over the years you have been doing trials? Yes. For reasons I still do not quite understand, Jason. There is a lower rate of diagnoses and certainly enrollment on to clinical trials for many, many malignancies in the summer, including very acute malignancies like acute myeloid leukemia. But particularly with diseases like ovarian cancer, many patients in the summer try to ignore their symptoms for a longer period. that is not a great way of saying it. But try to suppress the their concern over the summer and do not see do not get as many diagnoses over the summer as we would expect to see in the fall. Stacy R. Lindborg: Jason, we have just continued was just going to add with the continued enrollment that we are seeing, we have we fully expected that, and it gives us even more confidence in the timeline because we are we are still seeing very strong numbers manifesting. Douglas V. Faller: Yes. Jason McCarthy: Okay. And just lastly, going back to the MRD trial, is getting that second look laparoscopy commitment from patients challenging just given that it is a second procedure? Or does everybody kind of commit to doing that? Stacy R. Lindborg: Well, to enroll in the trial, they would have to be, you know, all trials require there to be a review of the protocol and the procedures they will go through, the all patients will go through. So to enroll in the trial, it is something you would have to align with. I do think that, you know, it is an innovative very innovative protocol, and it is ultimately establishing, you know, a relationship ultimately with endpoints that we would hope in the future would be easier to access. Right? This is part of how we advance science. We start out with, you know, if it is imaging, it could be know, other diseases, more comprehensive explorations, and then what you hope is to be able to get it down to something in the a blood test. And I do think that there are some really powerful translational assays that are being explored and in this trial ultimately should have a really compelling set of insights that are brought not only from doing the second look laparoscopy. This is a very compelling endpoint that ultimately gives confidence that in fact, which women are truly not seeing. Seeing advance advancement of the cancer and seeing minimal residual disease. Versus those that are not. But then ultimately being able to connect that to other measures that we have which should advance the field. So I do think it is it is going to be very, very, very exciting to see what we gain at the back end. Jason McCarthy: Great. Thanks for taking the questions. Look forward to the next updates. And when do you plan on putting out registration for the R&D Day? Stacy R. Lindborg: It will be coming soon. It will be coming soon. We will issue a press release, and we will we will, share details of the agenda. Look forward to the to those that come that come in person and also we will we will have a webcast. So it will be an exciting day. Well worth coming in. For those in the city, coming to be with us in person and being able to interact with the esteemed faculty in person. Great. Thank you. Operator: Thank you. And your next question comes from David Bouth from Zacks Small Cap Research. Please go ahead. David Bautz: Hey. Good morning, everyone. Appreciate you taking the question. I have got a couple on enrollment. Kind of as a follow-up to Jason's question. But do you see a site productivity increase kind of the longer the site is open? So I know you talked a little bit about seasonality, but just do you see any increase in kind of that average 0.5 patient per month per site increase the longer the site is open And then I am also wondering if you are seeing any meaningful differences in screening or enrollment rates for HRD positive versus HRD negative patients? Douglas V. Faller: Douglas, do want to start? I would be happy to. David, your point about enrollment increasing as the site becomes more comfortable with it, I would say that is a generally something that we have seen, although the exception to that rule is the very first site that we opened which enrolled amazingly from day 1. But certainly, in sites that for example, sites that were not part of OVATION 2, there is a learning curve. The pharmacy learns how to prepare the drug, administer the drug, etcetera. But it is a very fast learning curve. Once 1 patient has been in, I think everybody becomes comfortable as they would with any new technology. And more patients are identified. And I have forgotten the second part of the question, which I thought I had written down. What was the second aspect? Is there any meaningful difference that you are seeing in the screening or HRD positive versus HRD negative? Yeah. Yeah. Thank you. No. No. Absolutely not. Patients have been enrolled essentially equally. Okay. David Bautz: And lastly, I know it is going to be too early to start thinking about this, but about the timing of the 2 interim analyses. And mostly, I am thinking about if you can comment on when those might be occurring in relation to, you know, the current overall enrollment timeline? Stacy R. Lindborg: Yeah. I will I will take that. David, a great question. It is early, but it is always great to be looking down the path. 1 of the things that is important when we think about the timing of interims, which is, as you all know, from our protocol and our plans, agreed upon in advance with the FDA. So they are event driven time points. And we will start that process once we have fully enrolled trial. The trial is fully enrolled, so it is something that we could actually talk about in greater detail in a later call and maybe go further into the trial design. But was arrived at not only with extensive simulations and understanding what the timeline is likely to be and when you might expect the events, which are, you know, deaths, unfortunately, but are critical to have in the standard of care arm so that you can ascertain and see the treatment effect that exists. So there is very careful thought given to confidence in decisions and ultimately for the FDA to see these characteristics and align that if we meet the criteria that is set that it would be worthy of a BLA filing for full approval. And we will certainly be able to talk more about that in the in the future. David Bautz: Okay. Great. Appreciate you taking the questions. Stacy R. Lindborg: Thank you, David. Operator: And your next question comes from Kemp Dolliver from Brookline Capital Markets. Please go ahead. Brian Kemp Dolliver: Hi. Thanks, and good morning. Just 1 topic, which is plans for site activations over the next few months. Stacy R. Lindborg: Thanks, Ken. I will just offer comments on that. So we have been extremely focused on activating sites to stay on track with our target timeline. We are tracking very well with that against our plan, as we have described. So to kind of give a broad sense of that, we have 35% of the plan sites that are already active or are in the process of being activated. So that is currently. And we have for the sites that remain to fill out the number of sites which we have planned We have close to double the number of sites identified that are required to fill those slots. So we are tracking extremely well, and feel very good about really about the engagements we are having. We still continue to have some incoming calls in addition to the calls that we are making. And it looks like we will be able to put together the full plan, really, in the time frame that aligns with our plan. Great. Brian Kemp Dolliver: Thank you. Stacy R. Lindborg: Thank you, Kemp. Operator: There are no further questions at this time. I would now like to turn the call back over to Stacy R. Lindborg President and CEO, for the closing remarks. Please go ahead, Thank you, Stacy. Stacy R. Lindborg: And thank you to everyone who joined us today and for all the thoughtful questions You guys always ask very meaningful questions. That allow us to talk more about our plans and how we are executing. So thank you for that. As you have heard today, we continue to make meaningful progress against every area that matters the most for our company and for the patients we serve, Our clinical data continue to strengthen Enrollment in OVATION III is progressing ahead of expectations. External validation of IMNN-001 continues to grow. And we have remained disciplined in how we are deploying capital and executing the business. We recognize there is still work that is important, ahead of us, and we believe the foundation we have built leaves us well positioned for the next stage of development. Our priorities remain clear, Execute on the phase 3 study, generate high quality data, and ultimately deliver a much needed treatment option for women with advanced ovarian cancer. With a clear clinical path a differentiated product profile, and a capital strategy designed, to support our path forward efficiently. We believe IMUNON is well positioned to deliver meaningful value creating milestones in the periods ahead We also look forward to seeing you at R&D Day in New York on September 23. Please mark it down. You will have an invitation to register soon. We look forward to keeping you updated on our progress and appreciate your continued interest and support. Have a great day, everybody. Operator: Ladies and gentlemen, thank you all for joining, and that concludes today's conference call. All participants may now disconnect. Before you buy stock in Imunon, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Imunon wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the strong pace of enrollment in the pivotal OVATION III study to the compelling Phase II overall survival data and growing investigator enthusiasm. The Phase II OVATION II study demonstrated a 14.7-month improvement in median overall survival in the intention-to-treat population, providing a high-confidence foundation for the Phase III program. Preliminary data from the MRD trial showed IMNN-001 was associated with a 100% rate of 'no evidence of disease' following frontline therapy compared to 56% in the control arm. Translational findings suggest IMNN-001 successfully remodels the tumor microenvironment from an immunologically 'cold' state to an 'active' or 'hot' state through localized IL-12 expression. The company is maintaining strict operational discipline by utilizing in-house manufacturing and sharpening organizational focus to advance late-stage programs faster than industry benchmarks. Management and employees have voluntarily elected to receive a significant portion of compensation in equity, signaling internal alignment with long-term shareholder value. OVATION III enrollment is currently tracking at 0.5 patients per site per month, significantly exceeding the initial plan of 0.3 and historical benchmarks of 0.2. The company expects to present final overall survival data from the OVATION II study at a major medical conference in early 2027. Management anticipates the MRD trial will reach full enrollment by the end of 2026, followed by a period of observation via second-look laparoscopy. Current cash and equivalents are expected to provide an operating runway through the end of 2026, with plans to explore disciplined capital-raising options for full Phase III execution. The company is actively activating sites for OVATION III, with 35% of planned sites already active or in process and a surplus of identified sites available to fill remaining slots. A June financing of up to $10 million was structured using non-convertible preferred stock and promissory notes specifically to minimize shareholder dilution and warrants. Management highlighted the absence of cytokine release syndrome and systemic toxicities across all studies, addressing the historical safety barriers of IL-12 therapies. The company noted that while the MRD trial shows encouraging signals, the small sample size means it was not specifically powered for statistical significance. Seasonality was identified as a potential headwind, as ovarian cancer diagnoses and trial enrollments historically fluctuate during summer months. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that the MRD trial was not powered for statistical significance but serves to demonstrate the depth of response and biological activity of IMNN-001. The trial confirmed that IMNN-001 can be safely administered alongside bevacizumab and in the maintenance setting. Management expressed high confidence in maintaining enrollment momentum due to extensive clinical trial simulations and a large pool of pre-identified backup sites. The learning curve for new sites is reported as very fast, with pharmacy and clinical teams adapting quickly after the first patient is enrolled. Interim analyses for OVATION III are event-driven (based on mortality events) and will commence once the trial is fully enrolled. The analysis plan was agreed upon with the FDA to ensure that meeting specific criteria could support a BLA filing for full approval.

IMNN-001 is the first frontline treatment candidate to demonstrate the potential for a clinically meaningful overall survival benefit in women newly diagnosed with ovarian cancer Enrollment in the Phase 3 OVATION 3 Study of IMNN-001 is expected to be completed by the first half of 2029, supported by strong Phase 2 clinical data showing significant overall survival benefit Company to hold conference call today at 11:00 a.m. EDT LAWRENCEVILLE, N.J., Aug. 11, 2026 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the three months and six months ended June 30, 2026, and highlighted recent business updates including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer. “The second quarter brought continued momentum for IMNN-001,” said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. “Enrollment in our pivotal Phase 3 OVATION 3 study continues to exceed our planning assumptions, reflecting the compelling survival data generated in OVATION 2, our highly favorable safety profile, and growing confidence among investigators in IMNN-001’s potential to improve outcomes for women with newly diagnosed advanced ovarian cancer.” “We were also encouraged by new preliminary data from our ongoing Phase 2 minimal residual disease (MRD) study, which showed a deeper antitumor response in patients treated with IMNN-001, including higher rates of circulating tumor DNA clearance and no evidence of disease following frontline therapy. We believe these findings provide further independent evidence of IMNN-001’s biological activity and reinforce the mechanism underlying the survival benefit observed in the OVATION 2 study, while we remain fully focused on our highest priority of efficiently advancing OVATION 3. Based on the data generated to date, we believe IMNN-001 has the potential to become the first frontline immunotherapy to meaningfully improve overall survival in advanced ovarian cancer and establish a new standard of care for women facing this disease.” RECENT DEVELOPMENTS IMNN-001 Corporate Development: Upcoming Events: FINANCIAL RESULTS FOR THE SECOND QUARTER 2026 Net loss for the second quarter of 2026 was $2.8 million, or $0.54 per share, compared with a net loss of $2.7 million, or $2.15 per share, for the second quarter of 2025. Operating expenses were $2.8 million for each of the second quarters of 2026 and 2025. Research and development expenses increased to $1.5 million in the second quarter of 2026 compared to $1.2 million in the same period of 2025. During 2025, the Company initiated enrollment in the OVATION 3 Study and in 2026 closed out the OVATION 2 Study. General and administrative expenses decreased to $1.3 million in the second quarter of 2026 compared to $1.5 million in the same period of 2025. FINANCIAL RESULTS FOR THE SIX MONTHS ENDED JUNE 30, 2026 Net loss for the first half of 2026 was $7.1 million, or $1.38 per share, compared with a net loss of $6.8 million, or $6.08 per share, for the same period of 2025. Operating expenses were $7.1 million for the first half of 2026 compared to $6.9 million for the same period of 2025. Research and development expenses increased to $3.8 million in the first half of 2026 compared to $3.4 million in the same period of 2025. During 2025, the Company initiated enrollment in the OVATION 3 Study and in 2026 closed out the OVATION 2 Study. General and administrative expenses decreased to $3.3 million in the first half of 2026 compared to $3.5 million in the same period of 2025. Net cash used for operating activities was $7.0 million for the first half of 2026, compared with $5.8 million for the same period last year. This increase was primarily due to trial-related expenses associated with the OVATION 3 trial. As of June 30, 2026, cash and cash equivalents were $6.9 million. Conference Call and Webcast The Company will be hosting a conference call to review second quarter 2026 financial results and provide a business update today, August 11, 2026, at 11:00 a.m. EDT. To participate in the call, please dial (800) 715-9871 (U.S. and Canada/Toll Free) or (646) 307-1963 (U.S./Toll) and ask for the IMUNON Second Quarter 2026 Financial Results Call (Conference ID 8021948). A live webcast of the call will also be available here. An audio replay of the call will be available for 90 days and can be accessed at (800) 770-2030 (U.S. and Canada/Toll Free) or (609) 800-9909 (U.S./Toll) using replay access code 8021948#. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2) and is currently conducting a Phase 3 clinical trial (OVATION 3). The first patient was dosed in the Company’s Phase 3 pivotal study in the third quarter of 2025. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com. Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing of enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), and include statements regarding our planned stock split. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, risks and uncertainties related to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Investor Contact:Valter PintoKCSA Strategic [email protected] (Tables to Follow) IMUNON, Inc.Condensed Consolidated Statements of Operations(in thousands except per share amounts) IMUNON, Inc.Selected Balance Sheet Information(in thousands) #  #  #

LAWRENCEVILLE, N.J., Aug. 04, 2026 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company developing DNA-mediated immunotherapies, today announced that the Company will host a conference call at 11:00 a.m. EDT on Tuesday, August 11, 2026 to discuss financial results for the second quarter ended June 30, 2026 and provide an update on its clinical development program with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy, including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer. To participate in the call, please dial (800) 715-9871 (U.S. and Canada/Toll Free) or (646) 307-1963 (U.S./Toll) and ask for the IMUNON Second Quarter 2026 Financial Results Call (Conference ID 8021948). A live webcast of the call will also be available here. An audio replay of the call will be available for 90 days and can be accessed at (800) 770-2030 (U.S. and Canada/Toll Free) or (609) 800-9909 (U.S./Toll) using replay access code 8021948#. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA-based gene therapy technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy being developed for the localized treatment of advanced ovarian cancer. IMNN-001 has been evaluated in multiple clinical trials including one Phase 2 clinical trial (OVATION 2) and is currently being studied in the ongoing Phase 3 clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com. Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing and enrollment of the Company's clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company's products, if approved, the potential efficacy and safety profile of our product candidates, and the Company's plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON's filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Investor Contact: Valter PintoKCSA Strategic [email protected]

Image source: The Motley Fool. Tuesday, May 12, 2026 at 11 a.m. ET Chief Executive Officer — Stacy Lindborg Chief Medical Officer — Douglas V. Faller Interim Chief Financial Officer — Jeffrey W. Church Executive Chairman — Michael Tardugno Need a quote from a Motley Fool analyst? Email [email protected] Stacy Lindborg: Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Faller, our Chief Medical Officer; and Mr. Jeff Church, our Interim Chief Financial Officer, who likely needs no introduction given his tenure with Imunon. He'll be walking through and reviewing our financial results for the fourth quarter and full year of 2025. Mr. Michael Tardugno, the Executive Chairman of our Board, is also on the line and will be available for Q&A. We entered 2026 with strong momentum following a truly transformational year in 2025. Our proprietary IL-12 immunotherapy, IMNN-001, continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer based on all available data thus far, both translational and clinical. And IMNN-001 is rapidly advancing in the OVATION 3 pivotal Phase III study. The urgency of this program remains front and center for our efforts to create value for our shareholders and to address the unmet need in ovarian cancer, which continues to claim far too many lives as the standard of care traditional chemotherapy in the frontline setting has not advanced in over 30 years. In our OVATION 2 study, IMNN-001 demonstrated the first ever overall survival benefit in a randomized frontline clinical trial for this patient population with a final overall survival readout showing continued improvement in median overall survival across the trial through 3 different analyses that were conducted. Starting first with the original Phase II clinical trial data readout in July of 2024, which was across all endpoints. The median overall survival benefit was reported as 11.1 months. The median overall survival improvement observed in the subsequent clinical data readout in December 2024 was 13 months. And as we disclosed this week, has now expanded to 14.7 months in the final review of the trial results. Moreover, patients treated with PARP inhibitors as maintenance therapy in addition to IMNN-001 and standard of care chemotherapy demonstrated a median increase in overall survival of more than two years. The timing of this final analysis was defined in the protocol to occur when the last patient enrolled in the trial had reached three years post treatment, and these truly unprecedented Phase II results have given our laser-focused execution of the ongoing rigorous Phase III trial, which was as agreed to with the FDA, is designed to confirm the Phase II results and support full regulatory approval. Throughout 2025, we showcased the strength of these Phase II clinical data and the compelling translational insights at major scientific forums highlighted by the platform presentation at the 2025 ASCO Annual Meeting and the simultaneous publication of the OVATION 2 study results in the peer-reviewed journal, Gynecological Oncology. We capped off the year with a highly successful R&D Day we hosted in November in New York City, and the investment community and leading clinicians heard directly from key opinion leaders about Imunon's ability to turn immunologically cold tumors hot, to remodel the tumor microenvironment and deliver meaningful clinical survival benefits to women with newly diagnosed advanced ovarian cancer where none had existed before. This momentum carried into 2026 with OVATION 3 trial enrollment well ahead of plan. In a protocol that is virtually identical to the Phase II study, OVATION 3 is a 1:1 randomized trial to evaluate IMNN-001 plus standard of care neoadjuvant and adjuvant chemotherapy, which includes interval debulking surgery versus the standard of care alone in women with treatment-naive advanced ovarian cancer. The adaptive trial design with interim analyses for early efficacy stopping rules provides 95% power on the primary endpoint of overall survival while offering the potential for accelerated time lines of a BLA for full approval. Key updates since our Q3 2025 results conference call underscore the strength of our Phase II foundation and the accelerating progress in Phase III based on the strong response from patients, our clinical trial investigators and the broader medical community. And I'll just highlight a few areas, starting with site activation status. Phase III trial enrollment remains strong with 7 clinical sites actively enrolling patients and up to 43 additional high-quality centers under evaluation or in start-up mode. Returning investigators from the OVATION 2 study have been joined by new top-tier centers, many proactively reaching out following our data presentations and publications. We have contracted a global CRO to support rapid advancement of Phase III trial site activation and the study overall. Turning to enrollment velocity. Building on the strong progress we reported in late 2025, patient randomization and treatment in the Phase III trial have continued at an impressive pace and enrollment remains ahead of plan. The early sites have delivered higher than the assumed rate of 0.3 patients per month with some sites delivering as high as one patient per month. This early momentum driven by the compelling Phase II study overall survival benefit positions us well for continued acceleration of site activation and patient enrollment. Our goal is to have approximately 80 patients enrolled in the trial within the next 12 months and enrollment completed in 2029. Turning to regulatory and design validation. Based on the FDA's endorsement of overall survival as the primary endpoint of the Phase III trial combined with a robust statistical framework and precedent in oncology clinical drug development, OVATION 3 continues to derisk the path to a potential regulatory approval in both the U.S. and Europe. On translational data and the MRD trial data, we have data from the ongoing Phase II minimal residual disease or MRD study in collaboration with Breakthrough Cancer Foundation. This trial further reinforces IMNN-001 novel mechanism of action with demonstration of preferential uptake of peritoneal macrophages, profound tumor microenvironment remodeling, complete pathological responses and durable IL-12 and interferon gamma expression with excellent tolerability, even in combination with bevacizumab. We've successfully capped our enrollment in the MRD study at 30 patients, allowing the trial to meet all core objectives and upon completion, channel resources and highly productive sites fully into the Phase III OVATION 3 trial. Preliminary data from the Phase II MRD study continue to align with the overall survival benefit shown in the Phase II OVATION 2 study and support potential label expansions in the future. I'll now turn over the call to Dr. Douglas Faller for clinical commentary. Douglas? Douglas V. Faller: Thank you, Stacy. The enthusiasm within the gynecologic community that we saw at our R&D Day in November and throughout 2025 has only grown. The Phase II OVATION 2 clinical data showing a clinically meaningful 14.7 month median overall survival benefit and the ability of Imunon to activate both innate and adaptive immunity continue to resonate strongly with our investigators. Our multiple presentations at leading congresses in 2025 highlighted Imunon's unique profile, localized IL-12 delivery with negligible systemic exposure, favorable safety and clear signals of immune activation predictive of superior outcomes. Interestingly, after seeing our data presentations, many investigators have been approaching us asking us to join our Phase III OVATION study rather than vice versa. I find this kind of initiative to be most unusual in my long experience conducting clinical trials and also very gratifying. It further supports the consensus of the significant potential of IMNN-001 to address the unmet medical needs in newly diagnosed ovarian cancer. OVATION 3 has leveraged this interest from day 1. As Stacy said, study start-up was completed in record time and early sites have exceeded enrollment forecast. Safety data remains clean, mirroring the excellent tolerability seen across our IMNN-001 clinical programs. The Phase II MRD study has provided real-time confirmation of the favorable safety profile with no dose-limiting toxicities, no discontinuations due to IMNN-001 and very encouraging trends in progression-free survival and MRD negativity. These consistent findings across our studies give us high confidence as we scale the Phase III pivotal trial. Back to you, Stacy. Stacy Lindborg: Thank you, Douglas. Before turning to our financial update, I want to highlight that 2025 was defined by disciplined execution and strategic focus. We advanced the most important development program in our history while navigating a challenging capital markets environment with prudence and foresight. Our multipronged financing strategy, combining targeted equity raises, opportunistic ATM usage and ongoing partnership discussions has allowed us to extend our cash runway while minimizing dilution and advance IMNN-001 as quickly as possible. Shareholder equity remains paramount. Every decision is stress tested against our commitment to fully fund the OVATION 3 study with long-minded investors. We're making solid progress on this front and believe that once we secure a lead investor, we will be able to assemble a syndicate quickly. While the markets are improving and our ongoing calls with strong investors remain highly encouraging, we recognize that this time -- this process inherently takes time. We will continue to balance the ultimate goal of financing the trial with long-term oriented investors against the need to prudently extend our cash runway. We firmly believe that successfully completing this full financing is in the best interest of all of our constituents, including patients who are at the center of everything we do and all shareholders as we believe this will enable our investors to realize significant value. We are encouraged by continued interest in potential nondilutive partnerships for our TheraPlas technology platform and IMNN-001. On the financing side, prudence of our -- prudent use of our ATM facility and warrant exercises supplemented our cash position in 2025. Monthly cash usage has been further optimized, and we announced a strategic reorganization in February 2026 to reduce nonessential costs and to sharpen our operational focus exclusively on OVATION 3, streamlining operations and focusing scientific leadership while preserving all critical expertise in the interest of all Imunon stakeholders. These actions, combined with our continued manufacturing efficiencies, which are great, are designed to deliver on our milestone with maximum efficiency. Now over to Church for a review of our fourth quarter and full year 2025 financial results. Jeff? Jeffrey W. Church: Thank you, Stacy. Details of Imunon's fourth quarter and full year 2025 financial results were included in the press release we issued this morning and in our annual report on Form 10-K, which we filed before the market opened this morning. As of December 31, 2025, cash and cash equivalents were $8.8 million, reflecting disciplined cash management and net proceeds from warrant exercises and targeted ATM uses during the year. We project that this cash balance, together with our ongoing financial activities and cost-saving initiatives extends our operating runway into the second half of 2026. Research and development expenses for 2025 were $7.8 million, which was significantly lower than 2024, primarily due to the completion of the OVATION 2 study, optimization of the MRD study and focused spend on the OVATION 3 study manufacturing and start-up activities. General and administrative expenses were down 8% year-over-year through streamlined operations and renegotiated commitments. Net loss for 2025 was $14.5 million or $6.83 per share compared to $18.6 million or $16.94 per share, reflecting meaningful improvement driven by our cost discipline. I just would like to remind everyone that all share and per share amounts reflect the 15-for-1 reverse stock split effective in July 2025 and the 15% stock dividend declared in the third quarter of 2025. With that financial review, I'll turn the call back to Stacy. Stacy Lindborg: Thank you, Jeff. And Desiree, with that, we'll open the call for questions. Operator: [Operator Instructions] Our first question comes from the line of Emily Bodnar with H.C. Wainwright. Emily Bodnar: My first one, have you presented the final data from OVATION 2 to the FDA, particularly on the PARP inhibitor patient population? And have you received any feedback from the FDA on focusing on this patient population first in your OVATION 3 study? And then maybe if you could just kind of outline how you're thinking about upcoming milestones and catalysts for 2026 and any OVATION 3 updates that you're considering for this year? Stacy Lindborg: Thanks, Emily. A very well formulated and comprehensive question. So let me take it in steps. So first, we have not presented the OS data to the FDA. We are incredibly excited by the fact that it continued to improve. But really, this last analysis reinforces exactly the plans that we have in place. I think you specifically asked about the PARP-treated patients. And while this is even a larger effect than what we see in the intent-to-treat population, we know that this is a relatively small group in the trial, and it becomes important that we're replicating the findings. So we will be presenting the data to the investor community, and we'll also be presenting it to the clinical community. In fact, we got an abstract submitted over the weekend to a meeting that will really afford us to have some great discussions with potential new principal investigators. So our focus right now is really around the Phase III trial ensuring that we're continuing to build the amazing momentum and excitement in the medical community around this data and then ultimately delivering on the trial. So maybe I'll stop there really quickly and see if there's anything else, Douglas, you want to add to the latest data. Douglas V. Faller: Just that although we're very excited about the results in the patients treated with PARP inhibitors, we're equally excited about the results that we see in the entire population. And this greater than a year increase in survival is, as you know, Emily, unprecedented in ovarian cancer. No one has seen anything like this in the entire time I've been practicing medicine. So the ability as we replicate this in the Phase III, this will be incredibly meaningful for patients and the whole population of patients is what I'm getting at, not just the patients who received PARP inhibitors. If they continue to benefit as much as they did in the Phase II, that's wonderful. But we're focused on benefiting -- providing benefit to the entire population of newly diagnosed women with advanced ovarian cancer. Stacy Lindborg: Thank you. Emily, if I remember correctly, the other questions were focused around upcoming catalysts and our plan for this year and beyond. And I would say that we have catalysts that we're going to be very excited to report back, one of them being around the momentum of the trial. And so you heard in my prepared remarks, that we are -- our goal is to have 80 patients enrolled by this time next year. And reporting our momentum will be a very critical component of ultimately the overall time line that we've been committed to. So that will be one catalyst. We will continue to have presentations at medical and scientific congresses. We have samples -- tissue samples still from OVATION 2 that we intend to analyze and have in the near term, a comprehensive analysis and publication around translational data that we think will really be very compelling for the scientific and medical community that we'll be able to go beyond what we've presented to date. And I think that will be a very meaningful contribution. We have the potential for partnership progress that may provide opportunities to extend the runway further. And of course, we are continuing with our strategic goal of financing the trial with long-minded investors. And those are all things that we're very, very actively involved with. So our plans for 2026 really are going to be focused on our funding for the company, making sure we have the cash runway and that we are really increasing our institutional base in the -- in parallel. And then second, enrolling the trial and ensuring that we're spending a lot of time with our partners that are involved in this trial and the broader medical community as we're really helping translate the value for women newly diagnosed and bringing forward a product that really should revolutionize the standard of care. Operator: Our next question comes from the line of James Molloy with Alliance Global Partners. James Molloy: Could you walk us through -- I know you gave excellent guidance, very clear guidance on 80 patients by this time next year and 2029 to complete enrollment of the trial. Could you walk us through what potential cut points for interim looks we might be able to anticipate going forward over the next 12 months? Stacy Lindborg: Yes. Great question, James. Thank you. So the interim analyses, which have been laid out are all very carefully designed through comprehensive simulations, which are always looking at the time frame in which you might expect to be able to see a successful hit, if you will, so a p-value that would allow you to file your BLA. And as you know, we've described this in the past, and we've had reviews of our protocol. We've designed these steps for there to be 2. So the important component, given what we know very well from the literature and other Imunon agents, we need to observe patients long enough to be able to see events in the control arm for there to be really the ability to have success. So we've designed these interims to occur after the point that we would have fully enrolled trial. And we expect based on the simulations that we've done in the past that the first interim would occur about a year after that. So that is what we're actively working towards. And it's, as always, designed to allow for if we see a bigger effect than we have assumed in the protocol, this interim, in fact, the first interim may provide and would provide an opportunity for us to act more quickly than waiting. But it also is important that we're being very careful with these interims and of course, because you're using type 1 error rate as you're ultimately doing these formal analyses. So that's kind of a bit of an insight into how we balance the various dimensions and what we can expect going forward. James Molloy: And then maybe a follow-up question on the final data on the OVATION 2 showing the excellent survival data. How did that change the potential partnership environment, if at all, that you can share with us? Stacy Lindborg: So it's obviously very early. We just released the data last week. We are participating tomorrow in the MedInvest Biotech & Pharma Investor Conference, and we are getting new inquiries that are occurring even as of this week. But I expect that to continue to develop. These kinds of partnerships, whether they're geographic in nature or they're more fundamental with big pharma really ultimately has to fit with a strategy and an interest and an intent from a timing standpoint. So -- but we're very pleased to see renewed and new inquiries. Operator: Next question comes from the line of Jason McCarthy with Maxim Group. Jason Mccarthy: Going back to OVATION 2, is there going to be an opportunity when you continue to mine that data? Will you have anything related to minimal residual disease or any SLL, looks for MRD or any more immune data that might be suggestive of T cell memory or something that's keeping these patients' disease kind of in check and that could be driving these longer-term survivors? Stacy Lindborg: Yes. Maybe I'll start and then I'd like Douglas to pick up. So we won't have anything from OVATION 2 that relates to the minimal residual disease or second look laparoscopy because it's an additional procedure that is not part of standard of care, and therefore, it wasn't implemented in OVATION 2 nor will it be implemented in OVATION 3. So that is an exploratory and it's an endpoint that I think has gotten a lot of interest as a potential predictor of overall survival that was incorporated into what we call the MRD study. So the OVATION 2 won't give insights into that, but we will continue to contribute not only to our own learnings, but also the literature from the trial that we're doing in combination with breakthrough cancer. But we do have other data that we'll be able to get from OVATION 2, and I'll let Douglas go into some of that. Douglas V. Faller: Yes, we've been -- over the last 9 months or so, as you know and alluded to, we've been releasing more and more translational data, and we have additional translational data to present, and we will -- we're planning on publishing that also. This may include looking at peripheral responses in addition to the responses that we've shown so dramatically in the tumor and the tumor microenvironment. So we're very excited about the translational data. Just to expand on what Stacy said, even though we call one of our trials MRD, MRD is not really officially established for ovarian cancer. There's no -- there are no criteria that have been shown to be predictive of a patient's outcome. The MRD study is an approach to start working on that. But that data has yet to evolve. And we will try to determine over time what the best approach to MRD might be for it to be predictive in ovarian cancer. It's something of great interest. This is in part why breakthrough cancer got involved in the MRD study because they also would like to be able to generate a test like MRD, which could be predictive of patient outcomes. And in addition, in our Phase III, we will be looking at circulating tumor DNA. This may end up being a marker for MRD. It's not established yet in ovarian cancer, but our trial might be one of the ones that could establish circulating tumor DNA as a predictive marker. So that's yet to come. Jason Mccarthy: Great. Are there going to be updates from the MRD study in 2026 that we could look towards as potential catalysts? Stacy Lindborg: It's possible. I think that it will ultimately depend really on the -- our interactions with the study PI, [ Dr. Amir Jazaeri. ] We know that he presented data that was very exciting to see the analytical data, and he decided to really take a cohort of patients and analyze them together rather than continuing to analyze patients over time, individual patients over time. And the clinical data, of course, will be continuing to evolve. So we're in early discussions with him around where we may present that in the medical community, and we'll be thinking very much about bringing forward insight. It will be an exciting other arena for information. Jason Mccarthy: And I don't know -- last question. I don't know if I'm overlapping what James had asked previously about enrollment timing. But when you get to the 80, are you going to release any details on the HRD status of the patients just so people can get a sense of the percentages that are in the trial or maybe in the trial? Stacy Lindborg: It's an interesting question. I think right now -- and if I just step back and I look at what we've learned with this final analysis, our -- the overall effect that we've observed in the all-comers population has continued to grow so substantially that while the underlying genetics, which right now plays a critical role in the maintenance therapy and become central to how the treating community is taking care of patients. What's interesting is that our principal investigators are probably as excited about the effect in the HR-proficient patients as they are in the HRD positive. And so it will continue to be a very interesting and important part of our Phase III trial. But I think that we will really be looking holistically at the full trial and be very excited because we're able to influence and extend the life of an all-comers population. So it's -- that's my thinking of this. And I think that we'll have to think very carefully about the exposure that we give to an ongoing Phase III trial. It's an open-label trial, and we'll have the ability where we find it important from an investor standpoint to think about maybe secondary endpoints and provide updates, but those will be taken with great caution just to preserve the integrity of the trial. Douglas, anything more? Douglas V. Faller: Yes. The only thing I wanted to add is, although this is an open-label study because to preserve data integrity, we and the company are blinded in terms of efficacy, not safety, but efficacy. So we will not even ourselves be seeing the efficacy data as the trial progresses in terms of the primary endpoint. Jason Mccarthy: Okay. So just also -- sorry, one more, just a hypothetical. I'm not sure if you'd have the answer for this or not. There is a trial that's going to read out in the second half of this year for an oncolytic virus in the relapsed/refractory setting for PROC for ovarian cancer that the expectation is that it can resensitize to platinum. So for chemotherapy, it suggests that if they're successful that it could change the standard of care potentially even in the neoadjuvant setting. And I'm bringing it up because this trial is going to take a long time OVATION 3 and if you thought about how some potentially new therapies that could be on the market could influence how patients are managed by the time you get to the OVATION 3 full top line data. Douglas V. Faller: Thank you for that question. We're certainly very aware of the drugs that are being developed in the relapsed/refractory space, both platinum-sensitive and platinum-resistant. The most patients, interestingly, their tumors are sensitive to platinum. The idea that you'd have to sensitize patients in the neoadjuvant setting or the adjuvant setting really is not something that is at all mainstream. Most patients do respond to chemotherapy. Unfortunately, durable responses are rarer and then you get into second and third-line treatments. As you know, there have been at least one and soon two drugs approved in different settings in second, third, fourth line patients who are not being treated with platinum again. And that's wonderful. We're very happy that there are drugs that provide a bit of a survival benefit in second or third line. But as we all know on the phone and in this call, putting the best therapy upfront and making the biggest impact on the tumor is critical if you're going to treat ovarian cancer successfully. So we're very happy to be in frontline, very proud of the fact that we're in frontline, and we believe that we will be providing advantage over time in terms of increases in survival to the patients that we are treating. Operator: Next question comes from the line of Kemp Dolliver with Brookline Capital Markets. Brian Kemp Dolliver: First, are the savings from the restructuring of any significance that we would see them -- the impact of them in the first half of this year? Stacy Lindborg: So Kemp, really, what we reported as a strategic restructuring really is around ensuring that we are using all of our resources to the best of our ability and focused on Phase III. So we're ensuring that we have the ability to hire and bring in needed expertise for the future as we're thinking about the commercial setting, and we're looking to the upcoming year and beyond. So it really is not about a pure number, but it is about just an ongoing evolution of making sure that we're taking the talent we have in-house that we're focusing our attention for each person to ensure that we're bringing the most value possible and that we're really removing anything that is off target from the OVATION 3, which is our sole focus right now. Brian Kemp Dolliver: Okay. And with regard to your commentary regarding the pace of enrollment at the site level, I'm going to split a hair, if I can, because it may be informative. Is that pace increasing, say, month-to-month? Or is it just -- has it just been consistently above your forecast? Stacy Lindborg: So I'll give you -- we only have, of course, the time frame from the very first patient to now. But we see that for the entire trial, we are above the assumption of 0.3 patients per month per site. So the -- if you look across all the sites, the average is above that. And when we -- the numbers that I was reporting of these sites that actually are delivering one patient per month or even just slightly below, that is across the whole time period that they're delivering. So I do think you tend to see kind of episodic enrollment that can happen, but the numbers that we're reporting are not singular months. They're summarizing the entire time thus far. And I do think we're hearing phenomenal feedback. We're spending time in the site -- in our sites that are actively enrolling patients. We're having calls regularly as well. These conversations in terms of the data, we get to see a broader set of the community, for example, with the abstract we were putting in over the weekend, you have quite a few PIs that were part of OVATION 2. They all got to be on this abstract and to see the excitement and their responses. Gratitude for being included and really just pure excitement with the data. Douglas, why don't you comment more? Douglas V. Faller: No, that's exactly right. This is the first time that they had seen the final data in terms of survival, and there was a great deal of enthusiasm. As you might expect, they were very happy that their patients have seen this much benefit. Stacy Lindborg: So we really think this will be a difference maker for OVATION 3 compared to OVATION 2. Going into OVATION 2, we had a lot of promise. We had a mechanism of action that made a lot of sense, was very clearly established in the literature. Phase III now, we have evidence of a clinical effect that's never been seen. And we continue to really hear that, that becomes very critical. We can actually see the numbers that are entering prescreening, and we see a very high rate ultimately coming through to randomization with really the exceptions being things like inclusion criteria not met, that will always be the case or inability, perhaps somebody that's traveled a very long way and doesn't feel like they can make the schedule. But really, the rate of being exposed to this potential the way that our -- one of our PIs who's been involved with our program for a long time, talks about this with patients is you're going to get the standard of care, which you'll get in this trial. If you do not have interest in research and in this protocol, if you want to consider being in this protocol and if you're randomized to the experimental arm, then you have a chance at a product that may extend your survival. So it's been a very straightforward discussion as they're describing it to us, and we're getting, as we might expect, a positive response from patients and from the sites. Operator: And our last question comes from the line of David Bautz Bouts with [indiscernible] Research. Unknown Analyst: So I just have a couple of financial questions. So as resources become available, is the company going to look to open additional sites in the U.S.? Or will you be looking ex U.S. to get any international sites open? And then as far as payments for the Phase III trial, I guess I'm just trying to look at how is it being paid for? Did you have a bulk paid upfront? Is it pay as you go? Like how is it structured? Stacy Lindborg: So David, great questions. I was having a little trouble hearing you. So let me respond to your questions. And if I don't hit on them, we'll have you ask further. So we are actively enrolling and accelerating the enrollment of trials. And right now, those are focused in the U.S., although we have sites in Canada that we know are very interested, and we have had conversations as we're looking to consider the strategy of if we want to accelerate further adding a European country as well. So we've already had some discussions with leading sites in Central Europe. So that's a conversation that we expect to advance over the next year. But right now, we believe that we'll be able to meet our enrollment accelerations, and we have a lot of confidence with the sites that we're going after and we're starting with in the U.S. So we think that's actually the best way to start. In terms of payments for the trial, these trials are structured -- this trial is structured pretty traditionally. You have contracts with individual sites. There are start-up fees and then fees as patients are being treated as part of the protocol. We have an ability to take advantage of what is standard of care and to have that be paid through the traditional routes and some of the procedures not be due to be paid by Imunon and we've taken full advantage of that to really structure the contracts accordingly. Operator: This concludes the Q&A. I'll turn the call back to Dr. Lindborg for closing remarks. Stacy Lindborg: Thank you, Desiree, and thank you all for joining this call. With the Phase III study enrolling ahead of plan, as we've just been talking about, the enduring strength of our Phase II overall survival data and the compelling translational evidence that Douglas spoke about and our sharpened financial discipline, we really know that Imunon is well positioned for milestones that will create value inflection in 2026 and beyond. We remain steadfast stewards of the resources you have entrusted to us and are fully committed to delivering a potential paradigm shift for ovarian cancer treatment while creating lasting shareholder value. We thank you for your continued support and look forward to future calls. Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining in. You may now disconnect. Before you buy stock in Imunon, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Imunon wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $463,900!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,294,401!* Now, it’s worth noting Stock Advisor’s total average return is 978% — a market-crushing outperformance compared to 211% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of June 1, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Imunon IMNN Q4 2025 Earnings Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Imunon Inc (NASDAQ:IMNN) reported strong progress in its Phase III Ovation 3 study, with patient enrollment on track and positive feedback from the medical community. The company's Immunon-001 treatment demonstrated a significant 14.7-month median overall survival benefit in Phase II trials, which is promising for future outcomes. Imunon Inc (NASDAQ:IMNN) has implemented a disciplined bridge financing strategy to advance its Ovation 3 study while minimizing dilution and maintaining shareholder value. The company has received positive reactions from the investment community regarding its progress and data presented, indicating strong investor confidence. Imunon Inc (NASDAQ:IMNN) plans to host an R&D Day in Q3 2026 to showcase its clinical and translational data, further engaging with the medical and investment communities. The capital funding environment remains challenging for Imunon Inc (NASDAQ:IMNN) and the biotech sector, potentially impacting future financing efforts. The primary challenge for the Phase III Ovation 3 study is the time required to fully enroll 500 patients and generate sufficient data for a BLA filing. The company's net cash used for operating activities increased significantly to $4 million in Q1 2026, compared to $2.8 million in the prior year, due to trial-related expenses. There is a risk that the time required for data to mature and reach a formal readout may be longer than some investors prefer, potentially affecting investor sentiment. Despite positive clinical data, the competitive landscape in ovarian cancer treatment is evolving, with new therapies potentially impacting Imunon Inc (NASDAQ:IMNN)'s market position. Warning! GuruFocus has detected 2 Warning Sign with IMNN. Is IMNN fairly valued? Test your thesis with our free DCF calculator. Q: I noticed you gave initial guidance on enrollment and completion for the first time. Can you walk through what gives you confidence in this timing and how demand for Ovation 3 enrollment has played into those assumptions? A: (Dr. Douglas Fowler, Chief Medical Officer) We are enrolling 500 patients in total and expect the last patient to be enrolled in Q1 2029. We are increasing the number of sites activated, and we expect to have approximately 80 patients enrolled a year from now, which should be a significant percentage of the total for the trial. Q: You've indicated that enrollment has been ahead of schedule. Can you quantify that and explain what's driving it? A: (Dr. Stacy Lindborg, President and CEO) We have consistently had more patients enrolled than forecasted. This is due to strong partnerships with early sites from Ovation 2, who are familiar with our product and have shown enthusiasm. (Dr. Douglas Fowler, Chief Medical Officer) The excitement and engagement from investigators have been strong, with some sites enrolling a significant number of patients upon activation. Q: Could you review the powering assumptions around Ovation 3 and how many months of overall survival (OS) you'd need to see? Also, how do you see the treatment landscape potentially shifting in ovarian cancer over the duration of the Ovation 3 trial? A: (Dr. Stacy Lindborg, President and CEO) The trial is unblinded due to ethical considerations. We have seen the treatment effect grow, with an improvement in median OS from 11 months to close to 15 months. We have interim analyses planned to allow for early stopping for efficacy. (Dr. Douglas Fowler, Chief Medical Officer) While there are new therapies being developed, they offer small advances. Our focus on frontline care with significant OS benefits remains critical. Q: How should we expect the SG&A spend to look going forward, given the recent reorganization? A: (Jeffrey Church, Interim Chief Financial Officer) We expect SG&A spending to remain consistent with the first quarter, around $4.5 million to $5 million per quarter. This will increase as we bring on more sites and enrollment steps up for the Ovation III study. Q: Have there been any discussions with the FDA about utilizing pathways like accelerated approval as you get to interim reads? A: (Dr. Stacy Lindborg, President and CEO) Our trial is designed for full approval, with interim analyses allowing for early stopping if thresholds are met. We have received positive engagement from the FDA, and our focus remains on achieving full approval. (Dr. Douglas Fowler, Chief Medical Officer) The FDA's recent guidance emphasizes OS as the primary endpoint, which aligns with our trial design. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Image source: The Motley Fool. Tuesday, May 12, 2026 at 11 a.m. ET President and Chief Executive Officer — Stacy R. Lindborg, Ph.D. Chief Medical Officer — Douglas V. Faller, M.D., Ph.D. Interim Chief Financial Officer — Jeffrey W. Church Executive Chairman, Board of Directors — Michael H. Tardugno Need a quote from a Motley Fool analyst? Email [email protected] Stacy R. Lindborg: Thank you. Good morning, everyone, and welcome to Imunon's First Quarter 2026 Financial Results and Business Update Conference Call. During today's call, management will be making forward-looking statements regarding Immuneon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, May 12, 2026. Imunon undertakes no obligation to revise or update comments made during this call except as required by law. With that said, I would like to turn the call over to Dr. Stacy R. Lindborg, Immunon's President and Chief Executive Officer. Stacy? Thank you, Brandon, and good morning to everyone joining us. On the call this morning. Joining me on the call is Doctor. Douglas V. Faller, our Chief Medical Officer, and Mr. Jeffrey W. Church, our Interim Chief Financial Officer. Who will review our financial results for 2026. Mr. Michael H. Tardugno, the Executive Chairman of our Board, is also on the line and will be available for Q&A. We have entered 2026 with continued momentum following what was truly a transformative year in 2025 and we have made strong progress since our last conference call. Douglas V. Faller: We recently announced the final clinical data from our completed Phase II study OVATION II of IMNN-001, our proprietary IL-12 immunotherapy continues to demonstrate its potential to redefine frontline treatment. Stacy R. Lindborg: For women with newly diagnosed advanced ovarian cancer. The pivotal phase 3 study, OVATION III, is advancing well and we remain on track to randomize approximately 80 patients by the end of 2027. The capital funding environment has been challenging not only for Imunon but also for the biotech sector generally. We continue to take steps to sharpen our focus on enrolling this important OVATION III study as rapidly as possible and to conserve cash. The reaction from the investment community to our progress and the data we have presented to date including the results from our OVATION II Phase II clinical study. Has been very positive. Focusing now on our phase 3 study, we do understand that the primary challenge is the time it will take to fully enroll this 500 patient trial and to generate sufficient data for a future BLA filing. Given the significant improvement in overall survival that we have seen in phase 2 and we expect to see in phase 3, our primary endpoint overall survival is both a major strength and a practical time consideration. On 1 hand, overall survival remains the gold and definitive standard for demonstrating efficacy in oncology. And would support a BLA filing based on a single pivotal trial. On the other hand, it requires some time for the data to mature and reach a formal readout. In fact, longer than some investors might prefer. We are solving this dilemma in 2 ways. First, through a disciplined bridge financing strategy that raises targeted capital to advance OVATION III and bring us closer to trial readout positioning the company to attract new fundamental investors. Second, by structuring these financings in a creative manner, designed to minimize dilution and limit pressure on immunon share price. This could include the upside of a deal utilizing preferred shares which are not immediately tradable have no warrants, with redemption at the market and would also increase shareholder equity. This kind of a deal could compare favorably to registered direct deals that are dilutive and often include investors with little long term interest in the company. We will have more to say on this in the near future and we will provide updates as they become available. As always, our goal is to finance the company while not forgetting our shareholders and to keep a sharp focus on our North Star, which is bringing an innovative and much needed new treatment option to women with advanced ovarian cancer. Our approach has always intended to be as investor friendly as the options available to us permit. Based on our unprecedented IMNN-001 clinical data thus far, we are confident that our program will attract investments from 1 or more strategic partners that is minimally dilutive or non dilutive. Looking ahead, we are planning an R&D Day event in 2026. And I look forward to inviting you to hear from our Immunon team trial investigators, and oncology experts on the value of our IMNN-001 program to clinicians and patients. The strong response from our current trial investigators patients, the broader medical community supports our belief in the significant potential of immunon001 to make a meaningful difference in women's lives. I know your attendance will be rewarded with the inspiring attitude of the physicians and scientists who are intimately involved with our unique proprietary DNA-mediated recruitment of the entirety of the body's defense against road malignancies. Something that we have the pleasure of experiencing on a regular basis. I will now turn over to Dr. Douglas V. Faller for clinical commentary. Douglas V. Faller: Thank you, Stacy. Building on your comments, the enthusiasm within the gynecologic oncology community continues to grow. Our Phase II OVATION II clinical data showing a clinically meaningful 14.7-month median overall survival benefit with IMNN-001 treatment plus standard of care chemotherapy and the ability of IMNN-001 to activate both innate and adaptive immunity remains highly compelling to investigators. Our scientific presentations have reinforced Immunon001's unique profile: localized IL-12 delivery with negligible systemic exposure, favorable safety, and clear signals of immune activation predictive of superior clinical outcomes. In addition, we look forward to presenting the final OS results from OVATION II at an upcoming national conference. As Stacy also mentioned, we are thrilled to share that our next R&D Day will be scheduled in Q3 2026. This event will showcase the final efficacy analysis from OVATION II, along with additional promising safety, efficacy, and translational data from our MRD study, and a new highly supportive translational data from OVATION II. Building on the transformative clinical and translational results we have already reported in the public domain, these presentations will further highlight the significant potential of IMNN-001. I am happy to say that investigators continue to proactively approach us about joining our phase 3 OVATION study. As Stacy said, enrollment is progressing nicely and remains on track. With current sites performing well. Safety data remains clean and consistent with prior clinical results, including data from the ongoing phase 2 MRD study. Which further support the favorable tolerability and unique mechanism of action of IMNN-001. These consistent findings give us high confidence as we advance the pivotal Phase 3 trial. Back to you, Stacy. Stacy R. Lindborg: Thank you, Douglas. Before turning to our financial update, I want to highlight that we remain focused on disciplined execution and strategic focus as we advance the most important development program in our company's history, IMNN-001, and, of course, with our initial sites on ovarian cancer. Our multipronged financing strategy continues to balance the need to extend our cash runway while minimizing dilution and moving IMNN-001 forward as quickly as possible. Shareholder value remains paramount, and every decision is stress test against our commitment to fully fund the OVATION III study. Now over to Jeffrey W. Church for a review of our first quarter 2026 financial results. Jeffrey W. Church: Thank you, Stacy. Details of Imunon's first quarter 2026 financial results are included in the press release we issued this morning and in our Form 10 Q, which we filed before the market opened this morning. We continue to manage our cash position prudently through targeted financing activities cost saving initiatives and operational efficiencies. Our disciplined approach, including the strategic reorganization announced earlier this year and the completion of the Ovation II study supports our ability to advance the OVATION III study while extending our operating runway. Research and development expenses increased to $2.3 million in 2026, from $2.2 million in the same period last year. During 2025, the company initiated enrollment of the OVATION III study. Also, in 2026, we have closed the OVATION II study. General and administrative expenses, remain unchanged at $22 million in each of the first quarters of 2026 and 2025. Net cash used for operating activities was $4 million in 2026. This compares to $2.8 million in the comparable prior-year period. This increase was largely due to the trial related expenses associated with starting up the OVATION III study. With that financial review, I will turn the call back to Stacy. Stacy R. Lindborg: Thank you, Jeffrey. Tina, that concludes our prepared remarks. If you could open the call for questions at this time. Operator: I would like to remind everyone if you would like to ask a question, press *1 on your telephone keypad. Again, that is *1 to ask a question. And our first question comes from the line of Emily Bodnar with H. C. Wainwright. Please go ahead. Analyst (Emily Bodnar): Hi. Good morning. Thanks for taking the questions. I noticed you gave initial guidance on enrollment completion for the first time. So maybe just kind of walk us through what gives you confidence in this timing and how demand for OVATION III enrollment has kind of played into those assumptions? Stacy R. Lindborg: Douglas, can you apprise us of our goals of fully enrolled when we expect the trial to be fully enrolled and other reflections on the interest in the trial. Douglas V. Faller: Yep. I am happy to. Hi, Emily. Thanks for your question. We are enrolling 500 patients total, as you know, in our study. And we expect the last patient to be enrolled in Q1 29. We are increasing the number of sites that we have activated and that is been a push this year. And we are expecting to have 80 patients enrolled, approximately a year from now, as I think you know, which should be 16% of the total that we will enroll for the trial. Stacy R. Lindborg: Great. Operator: Thank you. Your next question comes from the line of David Bouth with Zacks Small Cap Research. Please go ahead. Analyst (David Bautz): Hey. Good morning, everyone. Thanks for the update today. So, another question about enrollment. So you have been indicating, for a while now that enrollment has been, I guess, remaining ahead of schedule. Was I was wondering if you could just quantify that a little bit. Is this due to, you know, site efficiency investigator enthusiasm, patient demand? Stacy R. Lindborg: what is kind of driving that? Yeah, maybe I will start and, Douglas, you add. You know, trials always have an assumption of patients per site per month. And when we look at early in a trial, when you are starting with your early sites, always have internal targets by month that we are hoping to accomplish. And when we say we are ahead of target, it really reflects that by month we have consistently had more patients enrolled than we were than our forecast. I think that as we ultimately set goals, and it is very critical that we are completing the enrollment of this trial very expeditiously. You heard me reflect on our last earnings call that we were targeting this to be complete in 2029. That then becomes our true target, and it becomes critical that we are enrolling sites up to the number that we believe we need to be successful in doing so. And I would say we are tracking very well with the process of now a brand-new cohort of sites that are coming on board. I am really delighted by the early sites. These are obviously strong partners from Ovation 2, they know our product. They comment when we are with them in their centers of how visible it is to them when they are doing surgery on their patients, how different women who have been treated with IMNN-001 look relative to the control. And therefore it is not surprising that some of these are substantially above the assumptions that we have made for the number of patients you know, per site across the whole study, but it is been quite remarkable, you know, from that viewpoint. But Douglas, why do not you offer some additional perspective? Douglas V. Faller: Well, I will echo what Stacy said and also just mention that we have been very gratified at the excitement and the number of patients, some of the sites have enrolled upon just starting up. it is really a I think, a testimony to the belief of our investigators in the potential benefit of IMNN-001 that they are very aggressively identifying patients who should benefit and talking with the patients and putting these patients on study. So, again, just as Stacy has been pleased, our whole team, clinical team has been very happy with the strong engagement of the investigators. And as I said, in some cases, a flurry of activity as soon as their site is activated. Stacy R. Lindborg: Okay. Great. Analyst (David Bautz): And do you think this rate of enrollment has had any, like, any increased collaborator interest? at all? Stacy R. Lindborg: Collaborative, meaning partner, BD partner? Yeah. I do not think that is necessarily, interacting in terms of those 2 streams, but I do think that the opposite would be true if we are not successfully enrolling the trial, then you can expect that would have a negative impact on BD and I would say even investor interactions. But I think that this really ultimately being able to describe which Douglas has spoken of in the past, I think could elaborate on if you would like, but, you know, we continue to have sites that were not part of OVATION II that reach out, that are seeing our data presented in the scientific community when the paper came out with the full publication from OVATION II, We had outreach from centers, not just in The US, but in other parts of the world. And that enthusiasm tied with the other aspect of the visibility that we have gotten in the medical community really speaks volumes, and I do think all of those positively impact you know, all of our endeavors, partnerships, investors, etcetera. Analyst (David Bautz): Okay. Great. Appreciate you taking the questions. Stacy R. Lindborg: Thanks, David. Operator: Your next question comes from the line of Jason McCarthy with Maxim Group. Please go ahead. Analyst (Jason McCarthy): Hi, Stacy. Thanks for taking the questions. Could you just more of an abstract question. Could you just review with us-- sorry. Review with us the powering assumptions around OVATION III and how many months OS you would need to see And I know it is far off, but that interim data sometime in, call it, 20, 30 or so is that expected to be blinded or unblinded in terms of sacrificing some of the power and more broadly, there is been an uptick in clinical trial activity around PD-1 inhibitors. there is new ADCs. That have come after in HER 2. there is been a lot of activity around the PI3Ks in different categories. So how do you see the treatment landscape potentially shifting in ovarian cancer over the duration of the OVATION III trial potentially having an impact? Positive or negative. Stacy R. Lindborg: So those are great questions. Jason. Let me try to take them 1 at a time, and I think that, I will start with the first 2. Number 1, it is an unblinded trial in the sense of that patients and the treating clinicians are unblinded. As you know, the reason for that is the insertion of a catheter really makes it unethical to run a blinded trial, which the FDA agrees with us on that front. We would not want to have to insert an unneeded catheter in the standard of care patients who are randomized to standard of care. So that is separate from saying, is there structure and appropriate protection of the trial and integrity of the data that is occurring in the trial. And so there are components of what we do that really we will be operating in a manner in terms of access to data unless it is truly needed for the job and would fit best practices, we will be acting in a manner as if it is blinded internally. And in terms of the assumptions, you know, we have continued to see the treatment effect grow across the number of times that we refreshed the OVATION II data, and then finally, of course, the final readout as we prepared and now have closed out the trial. So we saw the trial go from initially an 11-month benefit over the standard of care in overall survival, median overall survival upwards to close to 15 months, which is really quite remarkable. And, you know, you will hear more from us in the future. We are really looking at how we can harness the final data set and how we can bring that to bear in terms of the phase 3 trial and if, in fact, it would permit us to pull forward the final analysis. So I would say it is early for us to talk about that, but it is something that we are carefully thinking through as any company would. When you have new information, you always want to make sure that your trial is really operating in the best information possible. So the trial that we have described in the past in this will continue, will have interim analyses. We have 2 planned, and right now they are designed to allow for an early stopping for efficacy that would occur about a year or a year and a half after the patients are fully enrolled. The second would occur about a year later, and I think that we will be offering more guidance on this front. So in the last piece is that in terms of the blinded and unblinded aspect as we are ultimately talking to investors and thinking about how we can align a financing with long-term minded investors that are really thinking about the course of this trial we will have the ability to spread the amount that we will need to run the full trial really over the course of this trial And 1 of the exciting aspects of the fact that it is an unblinded trial, it will, you know, permit us to allow for consideration of gaining and giving insight publicly into the secondary endpoint. So to really build some confidence that we are observing what we are observing in secondary endpoints, which are all hard endpoints pathological scoring, and other such endpoints that were part of our OVATION II and really building a confidence that could de risk financings and tranches, especially over time. So those are things that we are working through and have resonated well with our discussions with investors. On the front of the changes happening in the competitive landscape, Douglas, can you offer some perspective? Douglas V. Faller: I would be happy to, Jason. So as a clinician, I am very excited that there are second line plus therapies being developed, including the ADCs you mentioned. And also actually bare antibodies. The community is excited by this because we have been so limited in what we could provide patients, second and third line and fourth line. While these are advances, I think 1 has to say that they are small advances The benefits in terms of PFS, the benefits in terms of survival are poor. Or, let's say, not terribly strong. We are talking months and they are certainly not curative, as you know. Yet they are going to be available for our patients second and third line, both the treatment arm and the control arm. And so the implications on our study are really modest, I think. In addition, just to further emphasize the importance of frontline care, which is what we are delivering Even PARP inhibitors, which as maintenance have improved PFS in patients with frontline ovarian cancer. These are now being restricted more and more. The actual benefit of the PARP inhibitor, some of them, have led to the FDA walking back some of the approvals. This does not affect our study. We are using PARP inhibitors as the FDA has suggested. But it just to me, further highlights the need for new and effective treatments up front. Which is what we are delivering. So the landscape for patients, second and third line, has improved somewhat. Maintenance perhaps less so But we are in front of all of these things, and we are expecting we are hoping to reproduce the results we saw in OVATION II, which are not a few months benefit in survival, but over a year in survival. that is our ambition. Stacy R. Lindborg: Great. Thank you both for your answers. Analyst (Jason McCarthy): Great. Thank you, Jason. Operator: And our next question comes from the line of James Molloy with AGP. Please go ahead. Analyst (Matt): Hi, guys. This is Matt on for James Molloy today. Thank you guys for taking our and congrats on the progress this quarter. Just a few from us. How should we expect the SG&A spend to look going forward given the recent reorganization? And then I have a follow-up on clinical. Stacy R. Lindborg: Matt, it is a great question. And, Jeffrey, do you wanna-- do you wanna cover just high level what we expect by quarter? Jeffrey W. Church: Right. Based upon our current projections after the reorganization that occurred that we implemented in the first quarter, we are looking at spends over the next, you know, coming quarters in the 4.5 to 5 million. We expect that our G&A level to remain fairly consistent with where we were in the first quarter. But we would see an increase as we, bring on more sites and enrollment starts to step up as it relates to the OVATION III study. Stacy R. Lindborg: And, Matt, just to follow-up on a point to what Jeffrey just provided. What we shared in terms of the strategic restructuring, there were positions eliminated, but there also were jobs that were redefined. And so a huge part of this is ensuring that not only our resources are being well served. Clearly, do not want to carry resources that are not directly contributing to our top priorities, but it also is really about making sure we can go as quickly as possible and that we are all focused on the launch of the Phase III trial directly towards the completion and preparation for the commercial landscape, both in the manufacturing side and as we begin to prepare for the BLA. Analyst (Matt): Great. Thanks for that. And then in terms of just the kind of reorganization broadly, at the FDA, have there been any discussions about you know, utilizing some of these pathways like CBER later down the line, accelerated approval as you guys get to the interim reads, and how have those gone with this new kind of administration there. Stacy R. Lindborg: Yes. I think that, you know, we have designed a really well thought out trial, which has always received very positive and professional engagement with the FDA. So we have described over time, but I never get tired of reflecting on the point that we got it in writing from the FDA that they had no safety concerns about the trial right around the time that we were finalizing the protocol and the end of phase 2 meeting. So, you know, we clearly understand that we have designed a trial that sets us up for filing if we are successful, if the trial meets the statistical thresholds. And it is also under the agreement with the FDA interim analyses are a core part of the trial design and the analysis plan. They are designed to allow for full approval of the group that is being analyzed in that interim analysis if we meet the threshold. So as with all phase 3 trials, clearly outline what that threshold will be. We have used a very efficient alpha spending for the interim analyses, but that probably goes beyond what you are wanting to talk about, but that is something we care a lot about is being very efficient and ensuring that we are giving enough of an opportunity to the interims but then ultimately allowing the final analysis to really be set up very effectively. So we are really not right now with this phase 3 trial focused on the idea of accelerated approval. We are focused on full approval. But I do think we will keep a line of sight to ways and opportunities that maybe will allow, you know, additional interactions with FDA, maybe more accelerated and higher priority, or if we reach a point in time where we want to formally engage FDA around programs that they are speaking about. Douglas, do you have anything you want to add to that? Douglas V. Faller: I just wanted to add 1 thing. As you know, Matt, accelerated approvals are usually based on early surrogate endpoints. And the upheaval at the FDA and some of the decisions that they have made really do not affect us. We are looking at OS. And the FDA actually just recently issued a guidance saying for oncology trials, we want to see OS as the primary endpoint. that is always been our intention. That is how our trial is written. And we would not expect any surprises in taking an OS benefit to the FDA. It would be in oncology and all my years of experience, an OS benefit is never questioned. So we are not we are not having to deal with we will not have to deal with potential changes in what is expected by the FDA. We have the gold standard and what they call the gold standard as our primary endpoint. Analyst (Matt): Great. Thank you guys for taking our questions. And congrats again on the queue. Stacy R. Lindborg: Thanks, Matt. Operator: This concludes the Q&A portion of the call. I will now turn the call back to Imunon's President and CEO for concluding remarks. Stacy? Stacy R. Lindborg: Thank you all for joining the call. With our Phase III trial OVATION III patient enrollment on track, the enduring strength of our Phase 2 overall survival data and the compelling translational evidence And our sharpened financial discipline, Imunon is well positioned for value inflecting milestones in 2026 and beyond. I want to assure you we remain steadfast stewards of the resources you have entrusted to us and are fully committed to delivering a potential paradigm shift in ovarian cancer treatment while creating lasting shareholder value. Thank you for your continued support. Operator: And this concludes today's conference call. You may now disconnect. Before you buy stock in Imunon, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Imunon wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Imunon (IMNN) Q1 2026 Earnings Transcript was originally published by The Motley Fool

IMNN-001 is the First and Only frontline treatment candidate to demonstrate the potential for a clinically meaningful overall survival benefit in women newly diagnosed with ovarian cancer Enrollment in the Phase 3 OVATION 3 Study of IMNN-001 is expected to be completed by Q1 2029, supported by remarkable Phase 2 data showing significant overall survival improvement FDA has reviewed and is aligned with Phase 3 protocol, confirms path to BLA Filing Company to hold conference call today at 11:00 a.m. ET LAWRENCEVILLE, N.J., May 12, 2026 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today reported financial results for the three months ended March 31, 2026, and highlighted recent business updates including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer. “Enrollment in our pivotal Phase 3 OVATION 3 trial continues ahead of plan, reflecting patient interest and strong conviction among principal investigators and the broader medical community in IMNN-001’s therapeutic potential,” said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. “Coupled with the unprecedented overall survival benefit observed in our Phase 2 (OVATION 2) study and an aligned path to BLA filing, IMNN-001 is well positioned to potentially transform the standard of care in advanced ovarian cancer.” RECENT DEVELOPMENTS Final Phase 2 OVATION 2 Study Data Show Continued Overall Survival Improvement with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer – On March 25, 2026, the Company announced final data from the completed Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT) in 112 women with newly diagnosed advanced ovarian cancer. IMUNON previously reported a median 11.1-month increase in overall survival (40.5 vs. 29.4 months) in the IMNN-001 treatment arm compared to SoC chemotherapy alone. Following the most recent and final data assessment, the Company reported a median 14.7-month increase in overall survival (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in overall survival (3.6 months delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in overall survival of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone. Importantly, with these new efficacy results, IMNN-001 continues to show a highly favorable safety and tolerability profile across all clinical trials, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment of this disease. IMUNON Sharpens Focus on its Promising Pivotal Phase 3 Ovarian Cancer Study – On February 5, 2026, the Company announced a strategic reorganization, the goal of which was to reduce operating expenses while supporting the Company’s focused strategy to rapidly advance the pivotal Phase 3 OVATION 3 clinical trial. FIRST QUARTER 2026 FINANCIAL RESULTS Net loss for the first quarter of 2026 was $4.3 million, or $0.84 per share, compared with a net loss of $4.1 million, or $3.15 per share, for the first quarter of 2025. Operating expenses were $4.3 million for the first quarter of 2026, compared to $4.1 million for the first quarter of 2025. Research and development expenses increased to $2.3 million in the first quarter of 2026 from $2.2 million in the same period of 2025. During 2025, the Company initiated enrollment in the OVATION 3 Study and in 2026 closed out the OVATION 2 Study. General and administrative expenses remained unchanged at $2.0 million in each of the first quarters of 2026 and 2025. Net cash used for operating activities was $4.0 million for the first quarter of 2026, compared with $2.8 million for the same period last year. This increase was primarily due to trial-related expenses associated with the OVATION 3 trial. As of March 31, 2026, cash and cash equivalents were $4.8 million. Conference Call and Webcast The Company will be hosting a conference call to review first quarter 2026 financial results and provide a business update today, May 12, 2026, at 11:00 a.m. EDT. To participate in the call, please dial 800-715-9871 (U.S. and Canada/Toll Free) or 646-307-1963 (U.S./Toll) and ask for the IMUNON First Quarter 2026 Financial Results Call (Conference ID 8083343). A live webcast of the call will also be available here. An audio replay of the call will be available for 90 days and can be accessed at 800-770-2030 (U.S. and Canada/Toll Free), 609-800-9909 (U.S./Toll) or 647-362-9199 (Canada/Toll) using replay access code 8083343#. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2) and is currently conducting a Phase 3 clinical trial (OVATION 3). The first patient was dosed in the Company’s Phase 3 pivotal study in the third quarter of 2025. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com. Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the expected reduction of operating expenses related to the strategic reorganization, the timing of enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), and include statements regarding our planned stock split. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, risks and uncertainties related to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts: (Tables to Follow) IMUNON, Inc. Condensed Consolidated Statements of Operations (in thousands except per share amounts) # # #

LAWRENCEVILLE, N.J., May 05, 2026 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, announces that the Company will host a conference call at 11:00 a.m. EDT on Tuesday, May 12, 2026 to discuss financial results for the first quarter ended March 31, 2026 and provide an update on its clinical development program with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer. To participate in the call, please dial 800-715-9871 (U.S. and Canada/Toll Free) or 646-307-1963 (U.S./Toll) and ask for the IMUNON First Quarter 2026 Financial Results Call (Conference ID 8083343). A live webcast of the call will also be available here. An audio replay of the call will be available for 90 days and can be accessed at 800-770-2030 (U.S. and Canada/Toll Free), 609-800-9909 (U.S./Toll) or 647-362-9199 (Canada/Toll) using replay access code 8083343#. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2) and is currently conducting a Phase 3 clinical trial (OVATION 3). The first patient was dosed in the Company’s Phase 3 pivotal study in the third quarter of 2025. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com. Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing of enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), and include statements regarding our planned stock split. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, risks and uncertainties related to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts: