Imunon Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 11, 2026

Key Takeaways

  • Positive Sentiment: OVATION 3 enrollment is ahead of plan, with approximately 0.5 patients per site per month versus the planned 0.3 and historical rates of about 0.2. Imunon said 35% of planned sites are active or being activated and that it remains on track for its enrollment timeline.
  • Positive Sentiment: IMNN-001 continues to show encouraging efficacy and safety signals. In the Phase II OVATION 2 study, median overall survival was 45.1 months versus 30.4 months for control, while the company reported no cytokine release syndrome, systemic toxicities, or serious immune-related adverse events.
  • Neutral Sentiment: Preliminary data from the small Phase II MRD study showed lower minimal residual disease positivity with IMNN-001 than control, 44% versus 67%, alongside higher circulating tumor DNA clearance and rates of no evidence of disease. The trial remains ongoing, and statistical significance is uncertain because it was not powered primarily for that outcome.
  • Negative Sentiment: Imunon ended the quarter with $6.9 million in cash and said its current resources support operations only through year-end, despite reducing quarterly operating cash use to $3.0 million. Management acknowledged that additional capital will be needed to fully fund OVATION 3 and general administrative expenses.
  • Positive Sentiment: The company completed a financing of up to $10 million using non-convertible preferred stock and secured promissory notes with no warrants, which management said was structured to limit dilution and financing overhang. It also highlighted a 20% year-over-year decline in general and administrative expenses.
AI Generated. May Contain Errors.
Earnings Conference Call
Imunon Q2 2026
00:00 / 00:00

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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 2026 Financial Results and Business Update Conference Call. I will now turn the call over to Valter Pinto, Managing Director of Investor Relations at KCSA Strategic Communications, for introductions. Please go ahead.

Valter Pinto
Managing Director of Investor Relations at KCSA Strategic Communications

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 Lindborg, President and Chief Executive Officer, Dr. Douglas Faller, Chief Medical Officer, and Josh Blacher, Chief Financial Officer. Michael Tardugno, 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.

Valter Pinto
Managing Director of Investor Relations at KCSA Strategic Communications

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 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, and the company undertakes no obligation to update them except as required by law. With that, I'd now like to turn the call over to Dr. Stacy Lindborg. Stacy, please go ahead.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Thank you, Valter, 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 continued to demonstrate the strength of our data, which is earning growing recognition within the scientific community while remaining disciplined in our execution. Our North Star remains unchanged. Bring a much-needed new treatment option to women with advanced ovarian cancer, a disease that affects approximately 300,000 women worldwide each year, has a five-year survival rate of roughly 40%, and has seen little meaningful advancement in the standard of care for nearly three decades.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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 IMNN-001, the progress we've made, and the opportunities that lie ahead. Now 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 3 study. Third, the disciplined financial and operational execution across our company as we maintain focus and remain focused on advancing our phase III clinical trial. First up, continued validation of our technology and platform.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Turning to the clinical foundation that underpins everything we are doing, the final data from our completed phase II OVATION 2 study, which continues to strengthen our conviction in IMNN-001. Across successive analyses, we have observed a consistent and clinically meaningful improvement in median overall survival. Most recently, 14.7 months in the intention to treat an all-comers population of newly diagnosed patients. This alongside a highly favorable safety and tolerability profile that successfully addresses the historic barriers associated with systemic IL-12. Complementary translational findings, including lower rates of minimal residual disease, higher circulating tumor DNA clearance, and encouraging rates of no evidence of disease following frontline therapy further reinforce the biological activity of localized durable IL-12 expression at the tumor site. These consistent clinical and translational signals give us high confidence as we advance the pivotal phase III program.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Staying with the first theme and really 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 Break Through Cancer and is led by investigators at The University of Texas MD Anderson Cancer Center. The study is designed not only to evaluate clinical activity, but also to better understand how IMNN-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 IMNN-001 was associated with a lower rate of MRD positivity compared to the control arm, 44% versus 67%.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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% in the Imunon treatment arm versus 56% in the control arm. While these are preliminary findings from a small cohort, they provide encouraging evidence of deeper antitumor activity for 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 one that is immunologically active or hot. Finally, these encouraging biological and clinical findings continued to be accompanied by a highly favorable safety profile.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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 IMNN-001 has successfully overcome the historic safety challenges associated with IL-12-based therapies. Enrollment momentum in phase III and turning to our lead phase III asset, we remain very encouraged by the continued pace of enrollment in our pivotal OVATION 3 study. The trial continues to generate strong engagement from investigators and patients, reflecting the strength of the data generated in OVATION 2, which includes a well-established safety profile and compelling overall survival and efficacy results that we believe are unlike anything previously reported in the setting. Operationally, the team has executed with discipline and speed.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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 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 Faller, our Chief Medical Officer, who can expand on these data and offer perspective on the phase III progress in more detail. Douglas?

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

Thank you, Stacy. As Stacy mentioned, OVATION 3 is our pivotal phase III 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.

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

The encouraging survival and biomarker data generated in the OVATION 2 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 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.

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

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. 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. 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, we were invited to present at the inaugural AACR Drug Discovery and Development Congress, the D3 Congress, in July.

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

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. I'll now hand the call back to Stacy.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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 IMNN-001 and the opportunity ahead. Every decision we make is guided by a single priority, advancing our phase III OVATION 3 study as efficiently and thoughtfully as possible. That commitment is also reflected in how the leadership team and employees have chosen to be compensated. Leaders across the organization, as well as members of their teams, have voluntarily elected to receive a meaningful portion of their compensation in equity rather than cash. This is a tangible demonstration of the confidence we have in the program, our belief in the long-term opportunity, and our alignment with shareholders. At the same time, we remain disciplined stewards of capital, carefully allocating resources to maximize the value of our clinical programs while maintaining strong alignment with our investors.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

On the financing front, in June, we completed a financing of up to $10 million to support the OVATION 3 clinical program. The structure was designed with our shareholders in mind. Preferred stock, which is both non-redeemable and non-convertible, along with secured promissory notes. In this financing, there were no warrants, thus minimizing shareholder dilution and reducing financing overhang. Looking ahead, we will need to continue to strengthen our balance sheet with additional capital to support the full execution of the phase III trial as well as our G&A 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 Blacher, recently joined us as Interim CFO, to review our financial results. Josh?

Josh Blacher
Josh Blacher
Interim CFO at Imunon

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 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 3 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 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.

Josh Blacher
Josh Blacher
Interim CFO at Imunon

As of June 30, 2026, we had cash and cash equivalents of $6.9 million. Together with the financing we completed in June and our ongoing cost discipline initiatives, we believe this supports an operating runway through the end of the year. With that, I'd like to turn the call back to Stacy for closing remarks.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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

Operator

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 one on your telephone keypad to join the queue. If you would like to withdraw your question, simply press star one 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. Your first question comes from Emily Bodnar from H.C. Wainwright. Please go ahead.

Analyst at H.C. Wainwright

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've been seeing with IMNN-001 would be sufficient to show a statistically significant improvement versus control? How important is this numerically higher rate of no evidence of disease versus control? On top of that, also, when you discussed the September R&D Day coming up, do you plan to disclose any data from the ongoing trials, including the MRD trial and the OVATION 3? Lastly, for the rapid site activation that you've been discussing, is this sustainable? What's increasing your confidence in this going forward? Is there potential for any adjustments to enrollment timelines that might be quicker than the first half of 2029 timeline?

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

I'd be happy to. The MRD trial is a small trial, and we certainly may reach statistical significance. The trial is still ongoing. We're still enrolling patients and still assessing MRD by multiple means at the time when the patients have finished their adjuvant chemotherapy. Because it's a numerically small trial, whether we reach statistical significance or not, we will have to see as the trial progresses. We think that we will. The importance of this trial, I think that was also part of your question, is that this is another way of showing the increased depth of response that we get by adding Imunon 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 Imunon.

Douglas Faller
Douglas Faller
Chief Medical Officer at 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. Clearly, when you've completed therapy, having residual disease is not a good thing to have. So the fact that we can clearly decrease molecularly and microscopically and macroscopically the amount of any disease remaining is quite important, I think, prognostically for the patients, and completely consistent with the improvements in survival, the very impressive improvements in survival that we saw in the OVATION 2 study. There was one other part of your question. I think you were asking, are we going to be talking about MRD in OVATION 3? We are assessing things like circulating tumor DNA in the phase III study, but we do not have that data available at this time to discuss at R&D Day. Stacy?

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Sorry. Thank you. Thanks, Douglas. I'll offer a few other comments. In terms of the statistical significance of the MRD trial, it's always important to understand how a trial was planned. That trial, the sample size was not determined because of statistical power. 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 Jazaeri, who's the national PI, reflecting on the trial at the R&D Day. If the effect continues to be large, then one might see statistical significance, but that was not the goal, as Douglas pointed out.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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 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 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.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

We are 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. 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. We're feeling extremely confident, and we'll be working closely with these partners to ensure that we're delivering this trial as we've promised.

Analyst at H.C. Wainwright

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
Analyst at Maxim Group LLC

Hi. Good morning. Thank you for taking the questions. It is kind of a multi-part question, all related to the MRD study, if you would bear with me. What is the expected timing to complete this smaller MRD study, and will the study ultimately, or the results, be published? Is the Gynecologic Oncology Group, or the GOG, involved in any way, or were they potentially becoming involved, given that there is currently no MRD standard for ovarian cancer? 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.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Thank you, Jason. Those are great questions. 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 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, 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. The trial itself is growing and increasing, and we have continued to have discussions with Break Through 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 one, that we know now that Imunon can be safely treated, administered concomitantly with bevacizumab.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

That was one internal goal that we had and wanted knowledge of. That has already been accomplished. Number two is focused on the ability to treat women with Imunon in the maintenance setting, and we have women that are receiving treatment in the maintenance setting. Outside of the questions that you have asked relative to this landscape, we are very pleased with those learnings. We would expect, I would say, 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 input, specifically to the phase III trial.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

We had an advisory board with them, and we have GOG sites that are involved in our phase III 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?

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

Certainly. There's a fact that. I'm sorry, were you speaking, Jason?

Jason McCarthy
Analyst at Maxim Group LLC

No, I didn't say anything.

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

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. Stacy'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. This would be very helpful, most helpful if we had additional therapies to give to patients. One of the hard parts about determining the prognostic abilities of measurable residual diseases, the best way to do that is to have a therapy which actually impacts on the outcomes of the patients. And we believe that we did this quite impressively in OVATION 2.

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

We improved overall survival. We believe that we can do this, we certainly hope that we can do this, repeat this in OVATION 3, and therefore, we'd have a population of patients in which we use studies like circulating tumor DNA in a population in which we advanced and improved on overall survival. It's those kind of studies that can validate and make the FDA look at something like circulating tumor DNA as an important prognostic marker. We hope in OVATION 3 to be able to contribute to the ongoing work to develop a good MRD assay for ovarian cancer.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Thank you.

Jason McCarthy
Analyst at Maxim Group LLC

Great. Thanks. I thought that this question might have been asked and answered about the potential continuation of the 0.5 patients per site per month rate. Is there any seasonality to enrollment? For ovarian cancer, is summer historically a little bit more challenging versus winter, or are there fluctuations that can change that number?

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

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 malignancies in the summer, including very acute malignancies like acute myeloid leukemia. 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.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Yeah.

Jason McCarthy
Analyst at Maxim Group LLC

Got it. Thank you.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

Yes.

Jason McCarthy
Analyst at Maxim Group LLC

Okay. Just lastly, going back to the MRD trial, is getting that second-look laparoscopy commitment from patients challenging, just given that it's a second procedure? Or does everybody kind of commit to doing that?

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Well, to enroll in the trial, all trials require for there to be a review of the protocol and the procedures that all patients will go through. So to enroll in the trial, it is something you would have to align with. I do think that it is a very innovative protocol, and it is ultimately establishing 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, if it is imaging, it could be other diseases, more comprehensive explorations. Then what you hope is to be able to get it down to something that is a blood test.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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 advancement of the cancer and seeing minimal residual disease, versus those that are not. Then ultimately being able to connect that to other measures that we have, which should advance the field. So I do think it is going to be very exciting to see what we gain at the back end.

Jason McCarthy
Analyst at Maxim Group LLC

Great, thanks for taking the questions. Looking forward to the next updates. When do you plan on putting out registration for the R&D Day?

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

It will be coming soon.

Jason McCarthy
Analyst at Maxim Group LLC

In September?

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

It'll be coming soon.

Jason McCarthy
Analyst at Maxim Group LLC

Okay.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

We'll issue a press release, and we'll share details of the agenda, and look forward to those that come in person, and also we'll have a webcast. It will be an exciting day. Well worth coming in. For those in the city, coming to be with us in person and being able to interact with the esteemed faculty in person.

Jason McCarthy
Analyst at Maxim Group LLC

Great. Thank you.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Thank you.

Operator

Your next question comes from David Bautz from Zacks Investment Research. Please go ahead.

David Bautz
Analyst at Zacks Investment Research

Hey, good morning, everyone. Appreciate you taking the question. I have a couple on enrollment, kind of as a follow-up to Jason McCarthy's question. Do you see a 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 that average 0.5 patients per month per site increase the longer the site is open? I am also wondering if you are seeing any meaningful differences in screening or enrollment rates for HRD positive versus HRD negative patients.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Douglas, you want to start?

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

I'd be happy to. David, your point about enrollment increasing as the site becomes more comfortable with it, I would say that's generally something that we have seen, although the exception to that rule is the very first site that we opened, which enrolled amazingly from day one. But certainly in sites that, for example, sites that were not part of OVATION 2, there is a learning curve. The pharmacy learns how to prepare the drug, administer the drug, et cetera, but it's a very fast learning curve. Once one patient has been in, I think everybody becomes comfortable, as they would with any new technology, and more patients are identified. I forgot the second part of the question, which I thought I had written down. What was the second aspect?

David Bautz
Analyst at Zacks Investment Research

Is there any meaningful difference that you're seeing in the screening or enrollment rates?

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

HRD.

David Bautz
Analyst at Zacks Investment Research

For HRD positive versus HRD negative?

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

Yeah.

David Bautz
Analyst at Zacks Investment Research

Yeah.

Douglas Faller
Douglas Faller
Chief Medical Officer at Imunon

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

David Bautz
Analyst at Zacks Investment Research

Okay. Lastly, I do not know if it is going to be too early to start thinking about this, but about the timing of the two interim analyses, and mostly I am thinking about if you can comment on when those might be occurring in relation to the current overall enrollment timeline.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Yeah. I will take that, David. It is a great question. It is early, but it is always great to be looking down the path. One of the things that is important when we think about the timing of interims, which is, as you will know from our protocol and our plans, agreed upon in advance with the FDA. They are event-driven time points, and we will start that process once the trial is fully enrolled. This is something that we could actually talk about in greater detail in a later call and maybe go further into the trial design that was arrived at, not only with extensive simulations and understanding what the timeline is likely to be and when you might expect the events, which are deaths, unfortunately, but are critical to have in the standard of care arm so that you can ascertain and see the treatment effect that exists.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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. We will certainly be able to talk more about that in the future.

David Bautz
Analyst at Zacks Investment Research

Okay, great. Appreciate you taking the question.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Thank you, David.

Operator

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

Kemp Dolliver
Kemp Dolliver
Analyst at Brookline Capital Markets

Great. Thanks, and good morning. Just one topic, which is plans for site activations over the next few months.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Thanks, Kemp. I will just offer comments on that. 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. 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. That is currently. 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 spots. We are tracking extremely well and feel very good about the engagements we are having.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

We still continue to have some incoming calls in addition to the calls that we are making and look like we will be able to put together the full plan really in the timeframe that aligns with our plan.

Kemp Dolliver
Kemp Dolliver
Analyst at Brookline Capital Markets

Great. Thank you.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Thank you, Kemp.

Operator

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

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

Thank you, Franz. 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 3 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 execute 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.

Stacy Lindborg
Stacy Lindborg
President and CEO at Imunon

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 23rd. 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.

Executives
    • Stacy Lindborg
      Stacy Lindborg
      President and CEO
    • Douglas Faller
      Douglas Faller
      Chief Medical Officer
    • Josh Blacher
      Josh Blacher
      Interim CFO
Analysts
    • Valter Pinto
      Managing Director of Investor Relations at KCSA Strategic Communications
    • Analyst at H.C. Wainwright
    • Jason McCarthy
      Analyst at Maxim Group LLC
    • David Bautz
      Analyst at Zacks Investment Research
    • Kemp Dolliver
      Analyst at Brookline Capital Markets
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