Imunon, Inc.(IMNN)Q2 2026 法說會逐字稿

Good morning. I will be your conference operator for today. At this time, I would like to welcome everyone to the IMUNON Second Quarter 2026 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 2026 Financial Results and Business Update Conference Call. Joining us today are Stacy R. Lindborg, President and Chief Executive Officer; Dr. 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 1995 and 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; the 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.

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 IMUN-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: bringing a much-needed new treatment option to women with 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 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 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 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 continue to strengthen our conviction in IMUN-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, 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 III program. Staying with the first theme and focusing more on the additional validation that comes through our Phase II 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 IMUN-001 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 IMUN-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 in the IMUN-001 arm, 87.5% versus 62% in the control arm, and a higher proportion of patients achieving no evidence of disease following frontline therapy — 100% in the IMUN-001 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 IMUN-001. The translational analyses continue to support IMUN-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 IMUN-001 has successfully overcome the historic safety challenges associated with IL-12-based therapies. Enrollment in Phase III: 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 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. 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 III progress in more detail.

Thank you, Stacy. As Stacy mentioned, OVATION III is our pivotal Phase III trial evaluating IMUN-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 IMUN-001 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 has 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 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 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 14.7-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 survival data have been published in Gynecologic Oncology and were presented at the ASCO Annual Meeting in 2025. We plan to submit the final overall survival data 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 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 (D3 Congress) in July. Additional emerging translational data fully documenting the ability of IMUN-001 in our clinical studies to effectively reprogram the immunologically cold tumor microenvironment of advanced ovarian cancers into a hot antitumor environment was just accepted for presentation at the annual Society for Immunotherapy of Cancer (SITC) conference in November 2026.

Thank you, Douglas. I would like to turn briefly to how we are managing the business, because our actions speak to the confidence that we have in IMUN-001 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, who recently joined us as Interim CFO, to review our financial results.

Thank you, Stacy, and good morning, everyone. Details of IMUNON's second 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. 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% compared with $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 would like to turn the call back to Stacy for closing remarks and to open the line for questions.

Thank you, Joshua. Operator, please open the line for questions.

Thank you. 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 the pound key. If you are called upon to ask your question and are listening via speakerphone on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Our first question comes from Emily Bodnar from H.C. 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 II MRD trial, do you believe that the MRD improvement rates that you have been seeing with IMUN-001 will be sufficient to show a statistically significant improvement versus control? And how important is this numerically higher rate of no evidence of disease versus control? On top of that, when you discussed the September R&D Day, do you plan to disclose any data from the ongoing trials, including the MRD trial and the OVATION III? And lastly, regarding 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 of 2029 timeline?

Great. Thank you. Thanks, Joey, for the questions. Douglas, do you want to start with the MRD trial question about how the trial was set up and whether it is likely to reach statistical significance?

Be happy to. The 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 numerically small trial, whether we reach statistical significance or not, we will have to see as the trial progresses. 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 IMUN-001 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 IMUN-001. 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 clearly decrease molecularly, 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 OVATION II. There was one other part of your question: are we going to be talking about MRD in OVATION III? We are assessing things like circulating tumor DNA in the Phase III study, but we do not have that data available at this time to discuss at R&D Day.

Thank you. I will offer a few other comments. In terms of the statistical significance of the MRD trial, it is always important to understand how the trial was planned. That trial's sample size was not determined based on statistical power alone. So at the end of the day, that is one influence on 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 principal investigator, reflecting on the trial at the R&D Day. If the effect continues to be large, one might see statistical significance, but that was not the primary 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; you will get greater insight into what we plan to cover. We do think it will be a very compelling set of presentations and will allow for interaction with key experts and clinicians who have been treating patients with IMUN-001.

Regarding enrollment sustainability, I would say yes. 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 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. Bringing on new sites really brings new reinforcements and the excitement level that we are continuing to see from the early sites. So we are feeling extremely confident, and we will be working closely with these partners to ensure that we deliver this trial as we 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. This is a multipart question all related to the MRD trial. Stacy, if you would bear with me. What is the expected timing to complete the smaller MRD study and will the study ultimately have results that will be published? Is the Gynecologic Oncology Group (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, I see the study as breaking new ground in how ovarian cancer could ultimately be managed. Thank you.

Those are great questions. Let me start and then Douglas can comment. On expected timing, the trial — this is an emerging endpoint. The second-look laparoscopy is something the FDA has expressed interest in, but it does require a second procedure for patients. The trial itself is growing and we have continued discussions with Breakthrough Cancer and the lead principal investigator around the progress of the trial. We are delighted that we have already accomplished a couple of goals. One, we know now that IMUN-001 can be safely administered concomitantly with bevacizumab; that was an internal goal we wanted to know, and it has been accomplished. Two, we have been able to treat women with IMUN-001 in the maintenance setting, and we have women receiving treatment in that setting. Outside of the questions about the landscape, we are very pleased with those learnings. 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 required to observe patients through second-look laparoscopy.

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 and have sought their strategic inputs specifically for the Phase III trial; we had an advisory board with them, and some GOG sites are involved in our Phase III trial. But right now, they have not been integral to the MRD trial plans. Douglas, would you like to add any comments?

Certainly. With respect to whether the MRD data will be published, absolutely. We are in discussions with the principal investigator about when he and we will start presenting data from this trial in national forums. I would like to expand a little on Stacy's comments about GOG. GOG, like everyone 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 most helpful if we had additional therapies to give to patients. One of the hard parts about determining the prognostic abilities of measurable residual disease is that the best way to do that is to have a therapy that actually impacts patient outcomes. We believe that we did this quite impressively in OVATION II — we improved overall survival. We hope to repeat this 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 overall survival. It is those kinds 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.

Thank you. One more question: is there any seasonality to enrollment for ovarian cancer? Is summer historically a little bit more challenging or winter? Are there fluctuations that can change that 0.5 patients per site per month number?

For reasons I still do not quite understand, Jason, there is a lower rate of diagnoses and certainly enrollment onto clinical trials for many malignancies in the summer, including very acute malignancies. Particularly with diseases like ovarian cancer, many patients in the summer try to ignore their symptoms for a longer period and do not get as many diagnoses over the summer as we would expect to see in the fall.

We have continued to see strong enrollment despite seasonality, and that gives us more confidence in the timeline because we are still seeing very strong numbers manifest. The plan for bringing on new sites provides reinforcements, and we remain confident.

Okay. And just lastly, going back to the MRD trial, is getting that second-look laparoscopy commitment from patients challenging, given that it is a second procedure? Or do most patients commit to doing that?

To enroll in the trial, patients must consent to the procedures that are part of the protocol, including the second-look laparoscopy. All trials require review of the protocol and the procedures participants will undergo. It is an innovative protocol and ultimately establishes endpoints that we would hope in the future would be easier to access. This is part of how we advance science: we start with more comprehensive procedures and hope to get to something like a blood test. There are powerful translational assays being explored in this trial that should yield compelling insights beyond the second-look laparoscopy. This endpoint gives confidence about who truly has residual disease, and being able to connect that to other measures should advance the field.

Great. Thanks for taking the questions. I look forward to the next updates. When do you plan on putting out registration for the R&D Day?

It will be coming soon. We will issue a press release and share details of the agenda. We look forward to those who can attend in person and we will also have a webcast.

Thank you. Your next question comes from David Bautz from Zacks Small Cap Research. Please go ahead.

Hey. Good morning, everyone. Appreciate you taking the question. I have a couple on enrollment as a follow-up to Jason's question. Do you see site productivity increase the longer the site is open? I know you talked a little bit about seasonality, but do you see any increase in the average 0.5 patients per month per site the longer the site is open? Also, are you seeing any meaningful differences in screening or enrollment rates for HRD-positive versus HRD-negative patients?

David, your point about enrollment increasing as the site becomes more comfortable with the study is generally something we have seen, although the very first site we opened enrolled from day one. For sites that were not part of OVATION II, there is a learning curve: the pharmacy learns how to prepare and administer the drug, etc. But it is a very fast learning curve. Once one patient has been in, the site becomes comfortable, and more patients are identified. With respect to HRD status, we have not seen any meaningful difference: patients have been enrolled essentially equally between HRD-positive and HRD-negative cohorts.

Lastly, I know it's early, but can you comment on the timing of the two interim analyses and when those might occur in relation to the current overall enrollment timeline?

Great question, David. The timing of interim analyses was agreed upon in advance with the FDA, and they are event-driven time points. We will start that process once we have fully enrolled the trial. The specifics were arrived at with extensive simulations and consideration of when you might expect the events — which in this case are unfortunately deaths, but are critical to ascertain the treatment effect. There is very careful thought given to confidence in decisions and ultimately for the FDA to see these characteristics and align that, so if we meet the predefined criteria it would be worthy of a BLA filing for full approval. We will discuss the details of timing at a later date when appropriate.

Okay. Great. Appreciate you taking the questions.

Your next question comes from Kemp Dolliver from Brookline Capital Markets. Please go ahead.

Hi. Thanks, and good morning. One topic: plans for site activations over the next few months.

Thanks, Kemp. We have been extremely focused on activating sites to stay on track with our target timeline. We are tracking very well against our plan. To give a broad sense, 35% of the planned sites are already active or in the process of being activated. For the sites that remain, we have close to double the number of sites identified that are required to fill those slots. We continue to receive incoming interest as well as making outbound calls, and it looks like we will be able to put together the full site plan in the timeframe that aligns with our overall plan. We feel very good about the engagements we are having.

Thank you.

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 closing remarks.

Thank you to everyone who joined us today and for all the thoughtful questions. You always ask meaningful questions that allow us to talk more about our plans and how we are executing. As you have heard today, we continue to make meaningful progress against every area that matters 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 IMUN-001 continues to grow. And we have remained disciplined in how we are deploying capital and executing the business. We recognize there is still important work 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 III 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.

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