Imunon, Inc. (IMNN) Earnings Call Transcript

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 Vother 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 Limborg, President and Chief Executive Officer, Dr. Douglas Fowler, Chief Medical Officer, and Josh Blanchard, Chief Financial Officer. Michael Tudargo, the company's Executive Chairman, is also on the line for the Q&A portion of today's call. Before we begin, I'd 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 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 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 the new announced filings in the series and the change commission, which are available at sec.gov and on the company's website. looking statements made on the call speak only as of today's date and the company undertakes no obligation to update them except as required by law with that. And now let's turn the call over to Dr. Stacy Lindbergh. Stacy, please go ahead.

Thank you, Valter, 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 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 Star remains unchanged. Bring a much needed new treatment option to women with advanced ovarian cancer. that affects approximately 300,000 women worldwide each year, has a five-year survival rate of roughly 40 percent, 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 3 Ovation 3 study. And third, the disciplined financial and operational execution across our company as we maintain focus and remain focused on advancing. our phase three 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 two Ovation 2 study, which continues to strengthen our conviction in Immunon OO1. In successive analyses, we have observed a consistent and clinically meaningful improvement in median overall survival. 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 Immunon 001 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 percent in the control arm. While these are preliminary findings from a small cohort, they provide encouraging evidence of deeper anti-tumor activity for immunon 001. The translational analyses continue to support Immunonta 01'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. reinforcing our belief that ME-9001 has successfully overcome the historic safety challenges associated with IL-12 based therapies. Enrollment momentum in Phase 3 and turning to our lead Phase 3 asset, we remain very encouraged by the continued pace of enrollment in our pivotal Ovation 3 study. The trial continues to generate strong engagement from investigators and patients, reflecting the strength of the data generated in Ovation 2. include the 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 three study startups. 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 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 3 progress in more detail. Douglas?.

Thank you, Stacey. As Stacey mentioned, Ovation 3 is our pivotal Phase 3 trial evaluating Immunon 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. encouraging survival and biomarker data generated in the OPCMATION-2 study, Growing familiarity with Ibn al-Zahra among investigators. a high conversion rate from prescreening 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 TheraPlas platform, which enables the safe and efficacious delivery of IL-12 to tumors and thereby solves a decade-long barrier, 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 Immunon 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, CITSE, 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 Immunon O-01 and the opportunity ahead. Every decision we make is guided by a single priority, advancing our pivotal phase three 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 This is a tangible demonstration of the confidence we have in the program. 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 three 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 Blasher, who recently joined us as interim CFO to review our financial results. Josh?.

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 are a 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 $1.5 million. 1.2 million for the same period last year, primarily reflecting higher clinical and manufacturing costs related to the Ovation 3 study. General and administrative expenses for 1.3 million for the second quarter, down approximately 20% when compared with the 1.6 million in the prior year period. 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, in 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. 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 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 2 MRD trial, do you believe that the MRD improvement rates that you've been seeing with immunon-001 would be sufficient to show a 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 discuss 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, Jory, 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?.

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. the time when the patients have finished their adjuvant chemotherapy but because it's 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 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 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. are assessing things like circulating tumor DNA in the phase three study, but we do not have that data available at this time to discuss at R&D day.

Stacey? Thank you. Thanks. I'll offer a few other comments. 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 powers. 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 Jazari, who's the national PI, reflecting on that 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 near 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 immunonone-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 the partners to ensure that we're delivering this trial as we've promised.

Great. Thank you for taking our questions and congratulations again.

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 be published. Is the gynecologic oncology group of 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 process. 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 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'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. 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 this landscape, we are very pleased with those learnings. And we would expect, I would say, 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? Sure.

Certainly. There's a... I'm sorry. Did you have... Were you speaking, Jason? No, no, I didn't say the same. 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 everybody taking care of patients with advanced ovarian cancer, is very interested in having a set of guidelines with respect to measurable residual disease. disease, this would be very helpful, most helpful if we had additional therapies to give to patients. the hard parts about determining the prognostic abilities of measurable residual diseases, 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 2. 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 in Ovation 3 to be able to contribute to the ongoing work to develop a good MRD assay for ovarian cancer.

Thank you. Great. Thanks. And I thought that this question might have been asked and answered about the continued or 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?.

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.