Imunon (IMNN) Q2 2026 Earnings Call Transcript

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DATE

Tuesday, Aug. 11, 2026 at 11 a.m. ET

CALL PARTICIPANTS

• 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

TAKEAWAYS

• Phase 2 Median Overall Survival -- 45.1 months in the treatment arm compared to 30.4 months in the control group, representing a 14.7-month improvement in the final OVATION II study results.
• PARP Inhibitor Maintenance Survival -- 65.6 months versus 41.4 months in the control arm, reflecting a 24.2-month increase for patients receiving maintenance therapy.
• Phase 3 Enrollment Rate -- 0.5 patients per site per month, exceeding the internal planning assumption of 0.3 patients and the historical industry rate of 0.2 patients.
• MRD Positivity Rate -- 44% in the IMNN-001 arm versus 67% in the control group, based on preliminary data from nine patients in each arm reaching the second-look laparoscopy endpoint.
• Circulating Tumor DNA (ctDNA) Clearance -- 87.5% for patients treated with IMNN-001 compared to 62.5% for the control group, indicating deeper antitumor activity in preliminary Phase 2 findings.
• No Evidence of Disease (NED) Rate -- 100% in the IMNN-001 treatment arm versus 56% in the control arm following frontline therapy in the minimal residual disease trial cohort.
• Research and Development Expenses -- $1.5 million for the second quarter, up from $1.2 million in the prior year period due to higher clinical and manufacturing costs for the OVATION III study.
• General and Administrative Expenses -- $1.3 million, a 20% decrease from $1.6 million in the prior year period, reflecting ongoing cost-containment initiatives.
• Net Loss -- $2.8 million, or $0.54 per share, compared to a net loss of $2.7 million, or $2.15 per share, in the second quarter of 2025.
• Cash and Cash Equivalents -- $6.9 million as of June 30, 2026, which management expects to support an operating runway through the end of the year.
• June 2026 Financing -- $10 million in aggregate gross proceeds, comprised of $2.5 million in preferred stock and $7.72 million in secured promissory notes.
• Net Cash Used in Operating Activities -- $3 million in the second quarter, down from $4 million used in the first quarter of 2026.
• Phase 3 Site Activation -- 35% of planned sites are currently active or in the process of activation, with more than double the required number of sites identified.
• Enrollment Completion Timeline -- Management expects to complete enrollment for the pivotal Phase 3 OVATION III study by the first half of 2029.
• Overall Survival Data Submission -- The company plans to submit final overall survival data to a major medical conference for presentation in early 2027.
• Global Ovarian Cancer Impact -- Approximately 300,000 women are diagnosed with ovarian cancer annually, with a current five-year survival rate of approximately 40%.
• Promissory Note Terms -- Two notes totaling $7.72 million carry interest rates of 5% and 8% per annum and mature 18 months after issuance.
• Site Management Benchmarks -- The company moved from protocol submission to site activation in six months, which management stated is a third of the time of external industry benchmarks.

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RISKS

• Lindborg stated, "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," indicating a requirement for future financing.
• Faller noted seasonal impacts on trial participation, stating, "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."

SUMMARY

Management of Imunon, Inc. (NASDAQ:IMNN) highlighted the continued validation of its TheraPlas platform through final Phase 2 survival data and preliminary findings from its minimal residual disease (MRD) study. The company reported that the Phase 3 OVATION III trial is enrolling patients at a rate faster than both internal forecasts and historical industry averages. Financial results for the second quarter reflected a decrease in general and administrative spending alongside a $10 million capital raise designed to minimize shareholder dilution. Leadership remains focused on advancing IMNN-001 as a potential frontline treatment for advanced ovarian cancer, with plans to present detailed translational data at an R&D Day in September 2026.

• CEO Lindborg reported that management has voluntarily elected to receive "a meaningful portion of their compensation in equity rather than cash" to align with long-term shareholder interests.
• The company confirmed the safety profile of IMNN-001 remains favorable, with CMO Faller noting there have been "no cytokine release syndrome, no systemic toxicities, and no serious immune related adverse events" observed to date.
• Management cited the completion of an internal goal confirming IMNN-001 can be safely administered concomitantly with bevacizumab.
• The Phase 3 trial advanced from protocol approval to first patient randomized in approximately two months.
• CMO Faller noted that IMNN-001 was shown to remodel the tumor microenvironment from an "immunologically cold state to 1 that is immunologically active or hot."
• The company identified 35% of its planned clinical sites as active or currently in the activation pipeline.
• Management plans to host an R&D Day in New York City on Sept. 23, 2026, to provide deeper insights into the DNA-mediated immunotherapy platform.

INDUSTRY GLOSSARY

• ctDNA (Circulating Tumor DNA): DNA fragments released by tumor cells into the bloodstream, used as a biomarker to monitor cancer presence and treatment response.
• IL-12 (Interleukin-12): A potent protein that helps the immune system recognize and attack cancer cells.
• IMNN-001: A DNA-based immunotherapy designed for the localized treatment of advanced ovarian cancer.
• MRD (Minimal Residual Disease): Small numbers of cancer cells that remain in the body after treatment, which can eventually lead to a relapse.
• NED (No Evidence of Disease): A clinical state where no cancer is detectable in the patient following treatment.
• SLL (Second-Look Laparoscopy): A surgical procedure performed after initial treatment to check for any remaining cancer cells.
• TheraPlas: A platform technology for the gene-based delivery of therapeutic proteins to treat solid tumors.

Full Conference Call Transcript

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.

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