Good morning. I will be your conference operator for today. At this time, I would like to welcome everyone to the Immunon Second Quarter 2026 Financial Results and Business Update Conference Call. I will now turn the call over to Vauter Pinto, Managing Director of Investor Relations at KCSA Strategic Communications for introductions. Please go ahead.

Thank you, Operator, and good morning. Welcome to the Munon Second Quarter 2026 Financial Results and Business Update Conference call. Joining us today are Stacey Lindberg, President and Chief Executive Officer, Dr. Douglas Fowler, Chief Medical Officer, and Josh Blatcher, Chief Financial Officer. Michael Tudargno, the company's Executive Chairman, is also on the line for the Q&A portion of today's call. Before I begin, I'd like to remind everyone that our remarks today include forward-looking statements. These statements are made pursuant to safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and include, but are not limited to, statements regarding the timing and enrollment of the company's clinical trials, the 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 and statements, and actual results may differ materially from those projected. Additional information on the factors that could cause actual results to differ is detailed in immune-announced filings from the Securities and Exchange Commission, which are available at sec.gov and on the company's website. Overlooking statements made on the call speak only as of today's date, and the company undertakes no obligations to update them except as required by law. With that, I'd now like to turn the call over to Dr. Stacey Lindberg. Stacey, please go ahead.

Thank you, Veldra, and good morning, everyone. Thank you for joining us today and for your continued support of Immunon. The second quarter marked another period of focused execution and key validation of both Immunon 001, our lead asset, and our Theraplast 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 Star remains unchanged. Bring a much-needed new treatment option to women with advanced ovarian cancer, a disease that affects approximately 300,000 women worldwide each year, has a five-year survival rate of roughly 40%, and has seen little meaningful advancement in the standard of care for nearly three 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 23rd in New York City. We look forward to providing a deeper look at the science behind Immunon-001, the progress we've made, and the opportunities that lie ahead. Now onto the second quarter, I'll begin by highlighting three 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 III 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 II Ovation II study, which continues to strengthen our conviction in Immunon 001. 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 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 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 three program. Staying with the first theme and really focusing more on the additional validation that comes through our phase two 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 Immunon001 remodels the tumor immune microenvironment following frontline treatment. Among patients who had reached the study's primary assessment and endpoint of second look laparoscopy, treatment with immunon 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 immunon 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% in the immunon treatment arm versus 56% in the control arm. While these are preliminary findings from a small cohort, they provide encouraging evidence of deeper antitumor activity for immunon 001. The translational analyses continue to support Immunon-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 one 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 MU-901 has successfully overcome the historic safety challenges associated with IL-12-based therapies. Enrollment momentum 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 2, which includes a well-established safety profile and compelling overall survival and efficacy results that we believe are unlike anything previously reported in this 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 III study startups. Enrollment rates are exceeding our internal assumptions with the majority of activated sites performing at or above plan. One, 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 in in-house manufacturing, we are demonstrating the operational excellence required to advance a late stage program of this importance. With that, I'll turn the call over to Dr. Douglas Fowler, our Chief Medical Officer, who can expand on these data and offer perspective on the Phase III progress in more detail.

Thank you, Stacey. As Stacey mentioned, Ovation III is our pivotal Phase III trial evaluating Immunon001 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 2 study, growing familiarity with Immunon001 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 and 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 across both treatment arms and a recent scheduled independent IDMC, Independent Data Monitoring Committee, review identified no new safety concerns. These enrollment and safety findings build on the foundation established by Ovation 2, which demonstrated a 14.7-month increase in median overall survival, 45.1 months versus 30.4 months, and a 24.2-month increase among patients who received PARP inhibitor maintenance, 65.6 months versus 41.4 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 2027. In addition, because of the unique technology of the Theraplast 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 D3 Congress, in July. Additional emerging translational data, fully documenting the ability of Immunod001 in our clinical studies to effectively reprogrammed 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, CITSI, conference in November, 2026. I'll now hand the call back to Stacey.

Thank you, Douglas. I'd like to turn briefly to how we're managing the business because our actions speak to the confidence that we have in IME-901 and the opportunity ahead. Every decision we make is guided by a single priority, advancing our pivotal Phase 3 Ovation 3 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 3 clinical program. The structure was designed with our shareholders in mind, preferred stock, which is both non-redeemable and non-convertible, 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 GNA 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 Josh Blasier, who recently joined us as interim CFO to review our financial results.

Thank you, Stacy, and good morning, everyone. Details of Immunon's second quarter 2026 financial results are included in the press release we issued this morning and our Form 10Q, 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 three study general and administrative expenses for 1.3 million for the second quarter down approximately 20 percent 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 one of the highest priorities for management. Net cash used for operating activities for the second quarter was 3.0 million down from 4.0 million used in the first quarter of 2026. As of June 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'd like to turn the call back to Stacey for closing remarks.

Thank you, Josh. I'd like to start with Operator to open the line for questions first before my closing remarks.

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 one on your telephone keypad to join the queue. If you would like to redraw your question, simply press star 1 again. If you are called upon to ask your question and are listening via loudspeaker 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 Bodner from HC Wainwright. Please go ahead.

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 two MRD trial, do you believe that the MRD improvement rates that you've been seeing with immunon-001 would be sufficient to show statistically significant improvement versus control? And how important is this numerically higher rate of no evidence of 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 3? And lastly, for the rapid site activation that you've been discussing, is this sustainable? What's increasing your confidence in this going forward, and is there potential for any adjustments to enrollment timelines that might be quicker than the first half of the 2029 timeline.

Great. Thank you. Thanks, Joy, for the questions. Douglas, do 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?

I'd be happy to. The MRD trial is a small trial, and we certainly may reach statistical significance. The trial is still ongoing. We're still enrolling patients and still assessing MRD by multiple means at the time when the patients have finished their adjuvant chemotherapy. But because it's a 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 immunon to standard-of-care therapy. We've 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've been able to substantially decrease that by adding immunon. 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've 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 2 study. There was one other part of your question, I think you were asking, are we going to be talking about MRD in Ovation 3? We are assessing things like circulating tumor DNA in the Phase 3 study, but we do not have that data available at this time to discuss at R&D Day. Stacey?

Thank you. I'll offer a few other comments. And so in terms of the statistical significance of the MRD trial, it's always important to understand how a trial 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's one 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 Jezari, who's the national PI, reflecting on the trial at the R&D Day. And if the effect continues to be large, then one 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 future. And you'll 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 aminone-01 for a couple of decades. Number three, 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 2. 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're able to complete the enrollment on our target timeline, and we're 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're continuing to see from the sites that were early in the trial. So, we're feeling extremely confident and we'll be working closely with these partners to ensure that we're delivering this trial as we've promised. Great.

Thank you for taking your questions and congratulations again.

And your next question comes from Jason McCarthy from Maxim Group, LLC. Please go ahead.

Hi, good morning. Thank you for taking the questions. It's kind of a multi-part question, all related to the MRD study, if you'd bear with me. So what is the expected timing to complete this smaller MRD study, and will the study ultimately, or the results, be published? is the gynecologic oncology group with the GOG involved in any way or were they potentially becoming involved given that there's 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 that study is kind of breaking new ground in how ovarian cancer could ultimately be managed?

Thank you, Jason. Those are great questions. So let me start and then Douglas, I'll turn it over to you. I know you have spent a lot of time thinking about how 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, you know, is growing and increasing, and we have continued to have discussions with breakthrough cancer and in the lead PI around the progress of the trial. and we're delighted that we've already accomplished a couple of goals. Number one, that we know now that immunon can be safely treated, administered concomitantly with bevacizumab. That was one internal goal that we had and wanted knowledge of. That has already been accomplished. Number two is focused on the ability to treat women with immunon in the maintenance setting. And we have women that are receiving treatment in the maintenance setting. So outside of the questions that you've 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're expecting and hoping that the trial will reach full enrollment. and then there's a timeframe that is required to observe patients through second look laparoscopy. But that's 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 input specifically to the phase three trial. We had an advisory board with them, and we have GOG sites that are involved in our phase three trial. But right now, they have not been integral to the plans around the MRD trial. Douglas, would you like to pick up and comment on any of the three questions that you'd like to add to?

Certainly.

There's a fascinating...

I'm sorry, did you have... Were you speaking, Jason? No, no, I didn't say something. Okay, I heard something, sorry. With respect to the question, will the MRD data be published? Absolutely. We're in discussions with the principal investigator as to when he and we will start presenting data from this trial in national forums. Excuse me. Stacey's comments about GOG, I'd like to expand them a little bit because part of the question. GOG, like every body 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. One of the hard parts about determining the prognostic abilities of measurable residual diseases, 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 2. We improved overall survival. We believe that we can do this. We certainly hope that we can do this, repeat this in Ovation 3. And therefore, we'd 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's 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 Innovation 3 to be able to contribute to the ongoing work to develop a good MRD assay for ovarian cancer.

Thank you.

And I thought that this question might have been asked and answered about 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 versus winter, or are there fluctuations that can change that number?

Douglas, what's your observation over the years you've been doing trials?

Yes, for reasons I still don't quite understand, Jason. There is a lower rate of diagnoses and certainly enrollment onto 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's not a great way of saying it, but try to suppress their concern over the summer and don't get as many diagnoses over the summer as we would expect to see in the fall.

Yeah, Jason, with the continued, I was just going to add, with the continued enrollment that we're seeing, we fully expected that, and it gives us even more confidence in the timeline because we're still seeing very strong numbers manifesting.

Yes. Okay.

And just lastly, going back to the MRD trial, is getting that second look laparoscopy commitment from patients challenging just given that it's a second procedure or does everybody kind of commit to doing that well to enroll in the trial they would have to be you know all all trials require for there to be a review of the protocol and the procedures that they will go through the all patients will go through so to to enroll in the trial it's something you would have to align with. I do think that, you know, it's an innovative, very innovative protocol, and it's 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 how we advance science. We start out with, you know, if it's imaging, it could be, you know, other diseases, more comprehensive explorations, and then what you hope is to be able to get it down to something that's 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, you know, endpoint that ultimately gives confidence, you know, that in fact, which women are truly not seeing, seeing advancement of the cancer and seeing minimal residual disease versus those that aren't. But then ultimately being able to connect that to other measures that we have, which should advance the field. So I do think it's going to be very exciting to see what we gain at the back end.

Thanks for taking the questions. Looking forward to the next updates. And when do you plan on putting out registration for the R&D date?

It'll be coming soon. It'll be coming soon. We'll issue a press release, and we'll share details of the agenda and look forward to those that come in person and also we'll have a webcast. 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.

Thank you.

Your next question comes from David Boats from Zach's Small Cap Research. Please go ahead.

Hey, good morning, everyone. I appreciate you taking the question. So I've 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 So I know you talked a little bit about seasonality, but just do you see any increase in kind of that average 0.5 patients per month per site increase the longer the site is open? And then I'm also wondering if you're seeing any meaningful differences in screening or enrollment rates for HRD-positive versus HRD-negative patients.

Douglas, do you want to start? I'd be happy to.

David, your point about enrollment increasing as the site becomes more comfortable with it, I would say that's generally something that we have seen, although the exception The exception to that rule is the very first site that we opened, which enrolled amazingly from day one. 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, et cetera. But it's a very fast learning curve. Once one patient has been in, I think everybody becomes comfortable, as they would with any new technology, and more patients are identified. And I forgot 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're seeing in the screening for HRD positive versus HRD negative?

Thank you. No, absolutely not. that patients have been enrolled essentially equally.

Okay. And lastly, I don't know if it's going to be too early to start thinking about this, but about the timing of the two interim analyses. And mostly I'm thinking about if you can comment on when those might be occurring in relation to, you know, the current overall enrollment timeline.

Yeah, I'll take that. David, it's a great question. It is early, but it's always great to be looking down the path. You know, one of the things that is important when we think about the timing of interims, which is, as you'll know, from our protocol and our plans agreed upon in advance with the FDA. So, they're event-driven time points. And we will start that process once we have fully enrolled trials. The trial is fully enrolled. So this is something that we could actually talk about in greater detail in a later call and maybe go further into the trial design that 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 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's 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's 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 future.

Okay, great. appreciate you taking the questions.

Thank you, David. And your next question comes from Kemp Dolliver from Brookline Capital Markets. Please go ahead. Great. Thanks. And good morning. Just, you know, one topic, which is plans for site activations over the next few months.

Thanks, Kemp. I'll just offer comments on that. So, you know, we've been extremely focused on activating sites to to stay on track with our target timeline we're tracking very well with that against our plan as we've described um so to to kind of give a broad sense of that we we have 35 of the plan sites that are already active or or are in the process being activated so that's currently and we have for the sites that remain to fill out the number of sites which we've planned, we have close to double the number of sites identified that are required to fill this out. So we're tracking extremely well and feel very good about really about the engagements we're having. We still continue to have some incoming calls in addition to the calls that we're making and look like we'll be able to put together the full plan really in the time frame that aligns with our plan. Great. Thank you. Thank you, Kemp.

There are no further questions at this time. I would now like to turn the call back over to Stacy Lynn Borg, President and CEO, for the closing remarks. Please go ahead.

Thank you, France. 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're executing. So thank you for that. As you've 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 Innovation 3 is progressing ahead of expectations. External validation of Immunana 01 continues to grow. and we have remained disciplined in how we're deploying capital and execute the business. We recognize there's still work that's important ahead of us and we believe the foundation we've built leaves us well positioned for the next stage of development. Our priorities remain clear, execute on the phase three 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 Immunon 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 23rd. Please mark it down. You'll have an invitation to register soon. And we look forward to keeping you updated on our progress and appreciate your continued interest and support. Have a great day, everybody.

Ladies and gentlemen, thank you all for joining, and that concludes today's conference call. All participants may now disconnect.