Imunon Q3 2026 Earnings Call Transcript

Imunon (NASDAQ:IMNN) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Imunon reported steady progress in its Phase 3 Ovation 3 study for ovarian cancer, with enrollment and site activation tracking well against plan.

The company entered into a CRADA with the National Cancer Institute to evaluate Imunon 001 across additional indications, enhancing development opportunities without diverting resources from Ovation 3.

Imunon sold its rights to ThermoDox to Vasodox Therapeutics, aiming to focus resources on its core program while retaining potential future value.

Financially, the company reported a stable R&D expense of $1.8 million and a net loss of $3.8 million for Q3 2026, with a cash position of $4 million and ongoing capital-raising activities to support trial completion.

Management emphasized the strategic focus on Ovation 3, the importance of upcoming interim analyses, and the need for additional capital to achieve enrollment goals.

Full Transcript

Bella (Conference Operator)

Good morning and thank you for standing by. My name is Bella and I will be your conference operator today. At this time I would like to welcome everyone to Imunon’s third quarter 2026 financial results and business update conference call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star then the number one on your telephone keypad.

To withdraw your question, press star one again. I would now like to turn the conference over to Valter Pinto, Managing Director at KCSA Strategic Communications, for introductions. Please go ahead.

Valter Pinto (Managing Director)

Thank you, operator, and good morning. Welcome to the Imunon third quarter 2026 financial results and business update conference call. Joining us today are Dr. Stacey Lindborg, President and Chief Executive Officer; Dr. Douglas V. Faller, Chief Medical Officer; and Josh Blacher, Interim Chief Financial Officer. Michael Tardugno, Executive Chairman, is also available for the question-and-answer portion of today’s call. Before I begin, I’d like to remind everyone that our remarks include forward-looking statements. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include, but are not limited to, statements regarding the timing and enrollment of the Company’s clinical trials, the potential of the Company’s therapies to address unmet medical needs, the market potential for its product candidates if approved, and the Company’s plans and expectations for its development programs.

Words such as may, will, expect, plan, anticipate, estimate, and intend identify these forward-looking statements. 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. The forward-looking statements made on this 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. Stacey Lindborg, President and Chief Executive Officer. Stacey.

Stacy Lindborg (President and CEO)

Thank you, Valter, and good morning, everyone. Thank you for joining us today and for your continued support of Imunon. On our second quarter call in August, I said our priorities were clear: execute our Phase 3 Ovation 3 study, generate high-quality data, and deliver a much-needed therapy option for women with advanced ovarian cancer. The third quarter was a period in which we advanced all three—continued Ovation 3 enrollment, additional external validation of the data, and further portfolio and capital structure actions.

We recently hosted our 2026 R&D Day in New York City, where clinical investigators presented the full case for the Phase 3 Imunon 001 study in frontline ovarian cancer, which included the final Phase 2 overall survival results, the preliminary minimal residual disease findings, and the path to a confirmatory readout in Ovation 3. Our North Star remains unchanged: bring a much-needed treatment option to women with advanced ovarian cancer, a disease that affects approximately 300,000 women worldwide each year, has five-year survival rates of approximately 41% for women diagnosed at stage three and approximately 20% for women diagnosed at stage four, and has seen little advancement in frontline care standard of care for well over two decades.

Before discussing our clinical progress, I’d like to highlight the three themes that shaped the quarter: first, independent validation of Imunon 001 from the National Cancer Institute, from an independent data monitoring committee, and from the investigators who presented at our R&D Day; second, continued enrollment momentum in our pivotal Phase 3 study, Ovation 3, now with a clearly defined path to two preplanned interim analyses; and third, the steps we’ve taken to sharpen the portfolio and strengthen the balance sheet so that every dollar and every person is pointed at Ovation 3.

Let me start with our R&D Day because it brought the entire investment case together in one place. On September 23rd in New York, we set out to answer three questions: why systemic IL-12 failed historically, why Imunon 001 is different, and why the next stretch of Ovation 3 is the value-defining chapter of this program. We did not answer these questions alone. Dr. Primal Thacker of Washington University School of Medicine, and the study chair of both Ovation 2 and Ovation, presented the Phase 2 Ovation 2 survival results and the Phase 3 design.

Dr. Amir Dizari of MD Anderson Cancer Center, the lead principal investigator of our Phase 2 MRD study, presented the preliminary clinical and translational findings. Dr. William Bradley of the Medical College of Wisconsin, a principal investigator across Ovation 1, 2, and 3, joined a pre-recorded conversation with a woman who was treated with Imunon 001 as a trial participant in Ovation 1 and who, nearly 10 years from her diagnosis, reported remaining free of recurrence.

The last conversation is the one I keep returning to. Everything else we discussed today—enrollment rates, interim analyses, capital structure—exists to make that outcome available to more women. A replay of the event and the full presentation materials are available on the Scientific Presentations page of our website. If you haven’t already participated in the event, I highly recommend it. Turning to our lead Phase 3 asset, we remain very encouraged by the continued pace of enrollment in our pivotal Ovation 3 study. The trial continues to generate strong engagement from investigators and patients, reflecting the strength of data generated in Ovation 2, including a well-established safety profile and compelling overall survival and efficacy results that, frankly, we believe are unlike anything previously reported in this setting. At the R&D Day, we also put the operating plan on the record.

We’re targeting 50% enrollment in the first quarter of 2028 and completion of enrollment in the first quarter of 2029. The first preplanned interim analysis, which is now aimed at the full intent-to-treat population versus the HRD-positive subgroup, will occur at 60% of the target overall survival events and is currently estimated for the first quarter of 2030. These timelines assume continued site activation and enrollment rates consistent with recent performance and remain subject to the usual variability of oncology trial execution.

A word on how we’re talking about enrollment. Earlier in the trial, we reported that we were running above plan in essentially every month. Monthly enrollment in a trial of this kind goes up and down, and we do not want to set an expectation against any single month’s rate. Therefore, we believe a better way to describe where we are is this: we’re enrolling consistent with our plan, we’re continuing to add sites, and we’re seeing screening and randomization activity across the network of sites rather than concentrated at a handful of centers.

We continue to make solid progress on site activation for the Ovation 3 trial. At the end of the quarter, we had 18 sites selected, with nine active and nine in startup. We also have additional sites that have expressed interest that we are currently under evaluation. Our goal remains to have all planned sites activated by the end of 2027. Patient enrollment is tracking consistently with our plan across active sites. Average enrollment has been approximately 0.4 patients per site per month, which is above the planning assumption of approximately 0.3.

We are encouraged by the early pace, and if we continue to activate sites in line with our plan and maintain strong enrollment productivity across the network, we expect to achieve our ultimate goal of completing patient enrollment by the first quarter of 2029. We remain focused on executing against both our site activation and enrollment timelines. During the quarter, we also entered into a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute’s Cancer Therapy Evaluation Program, which is often referred to as CTEP. This agreement is designed to support the continued development of Imunon 001 and the work being conducted under the National Cancer Institute Experimental Therapeutics, or NEXT, program, which is managed by CTEP, with CTEP assuming regulatory sponsorship.

Through this agreement, National Cancer Institute investigators will evaluate Imunon 001 across additional solid tumor indications and combined regimens, leveraging the expertise and clinical trial infrastructure of the National Cancer Institute and the National Clinical Trials Network. Given IL-12’s broad immunologic activity and the preclinical research we have conducted in-house, we believe Imunon 001 has potential beyond ovarian cancer and that it’s meaningful.

Importantly, Imunon will retain ownership of this background intellectual property and of new intellectual property solely generated by Imunon and the collaboration, including the right to use data generated under the collaboration for the research and development of Imunon 001, while the National Cancer Institute assumes operational responsibility for conducting the studies. What this all means is this provides a highly capital-efficient opportunity to expand the clinical trial evidence supporting Imunon 001 without diverting resources from our highest priority.

Any additional studies conducted under the CRADA remain subject to National Cancer Institute resource allocation and prioritization and are not expected to impact our primary focus on Ovation 3. We will make sure of this and that our priority remains unchanged. Our capital, our team, our execution remain firmly focused on advancing Ovation 3 as rapidly as possible and in the most efficient way possible. The CRADA broadens the opportunity for Imunon 001 while allowing us to maintain our full commitment to completing the pivotal Phase 3 trial in frontline ovarian cancer.

Before I hand over to Douglas to add some additional context around the NCI CRADA collaboration and broader operational updates, let me cover two additional corporate actions we’ve recently undertaken because they speak directly to that focus. Last month we announced an agreement to sell our rights to ThermoDox, our heat-activated liposomal formulation of doxorubicin, to Vasodox Therapeutics, which intends to advance the asset in glioblastoma. This is consistent with the strategy we have described for some time.

We want to find a committed development partner for ThermoDox rather than to carry it ourselves. And as many of you will be familiar with, ThermoDox is a legacy asset that had been fully written off our balance sheet, so this transaction creates a path to future value from something currently carried at zero. Under the agreement, upon closing, Imunon would receive an equity interest of approximately 4.76% in Vasodox, also the potential for up to $16.5 million in aggregate development and sales-based milestone payments along with tiered royalties ranging from 3.5% to 6% on net sales of ThermoDox-related products, if approved.

The sale is contingent on Vasodox completing a planned $2.5 million financing to support a Phase 1 trial in glioblastoma. Milestone payments and royalties, or value from our equity position, depend on Vasodox succeeding in financing, developing, and commercializing the asset. This transaction reflects our disciplined approach to portfolio management and capital allocation. And by transitioning ThermoDox to a development partner committed to advancing the program, we retain the opportunity to participate in future success while concentrating our resources on Imunon 001 and the pivotal trial where we believe we have the greatest opportunity to create meaningful value for patients and shareholders.

On the balance sheet, in late September we exchanged $1.2 million of outstanding debt plus accrued interest for non-convertible preferred stock, reducing the balance of that note by approximately 43% without issuing any common stock or warrants. Josh will take you through this detail. With that, I’ll now turn the call over to Dr. Douglas Fowler, our Chief Medical Officer, who will expand on the data and our Phase 3 progress in more detail. Douglas.

Douglas V. Faller (Chief Medical Officer)

Thank you, Stacy. As Stacy mentioned, Ovation 3 is our pivotal Phase 3 trial evaluating intraperitoneal IMNN-001 at 100 milligrams per meter squared in combination with standard-of-care neoadjuvant and adjuvant chemotherapy in patients with newly diagnosed advanced epithelial ovarian cancer. It is a randomized 1-to-1 approximately 500-patient trial in stage 3B or C or 4 disease recommended for neoadjuvant chemotherapy. Overall survival is the primary endpoint, and the design includes two preplanned event-driven interim analyses intended to support a potential earlier submission for full approval if the survival signal crosses the pre-specified threshold.

I had the opportunity to spend time at ESMO last month and came away further encouraged by the level of enthusiasm. We continue to hear about IMNN-001 from gynecologic oncologists from all over the world in conversations with trial investigators and treating physicians. There is a consistent interest in our approach and in the potential to improve outcomes in the frontline setting. Importantly, those discussions and the program at ESMO, in addition to other major scientific conferences, also reinforced what we see in the broader landscape.

We are not aware of any other programs in the industry pipeline that are expected to meaningfully change the frontline standard of care for newly diagnosed, treatment-naive patients in the near term. That combination of physician interest and a relatively stable therapeutic landscape continues to support our conviction in the Ovation 3 program. We continue to be very encouraged by the trial’s execution. As Stacy mentioned, site activation has proceeded efficiently, advancing from protocol submission to site activation in approximately six months and from protocol approval to first patient randomized in approximately two months, roughly one third of the external industry benchmarks. Enrollment is tracking to our projections.

Our trial plan assumed 0.3 patients per site per month against historical ovarian cancer studies that have generally enrolled approximately 0.2 patients per site per month, and we have been running at or above our planning assumption of approximately 0.3 patients per site per month, recently averaging approximately 0.4. To translate that for anyone newer to the story, these trials have been historically slow to enroll, and we built our plan assuming we would do better than that history — we are delivering.

Consistent to this plan in oncology, enrollment is the single biggest determinant of when a trial reads out, which is why we spend so much time and effort on it. From a clinical perspective, we believe these enrollment trends reflect several factors: the encouraging survival and biomarker data generated in Ovation 2, growing familiarity with IMNN-001 among investigators and a high conversion rate from prescreening to patient 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 visits has been excellent, electronic case report forms continue to be completed in a timely manner, and the resulting data are supporting the ongoing maturation of the trial database. Finally, the safety profile remains highly favorable and consistent with our prior experience to date. Across our randomized and controlled trials — Ovation 2, MRD, and Ovation 3, our largest trials to date — we have observed no cytokine release syndrome, no systemic toxicities, and no serious immune-related adverse events.

Safety remains comparable across both treatment arms, and recent independent data monitoring committee reviews have identified no new safety concerns in Ovation 3. We are also making progress on two important operational fronts. We have prepared the regulatory submission of Ovation 3 to Health Canada and, in parallel to the submission, have been meeting with potential sites across Canada. At the same time, we continue to expand our clinical site network with the goal of activating all planned sites by the end of 2027. Both of these initiatives are important to supporting enrollment and maintaining our planned development timeline.

Turning now to our Phase 2 translational minimal residual disease, or MRD, study, conducted in collaboration with Breakthrough Cancer and led by investigators at MD Anderson Cancer Center, we have had two notable developments this quarter. First, in July we reported encouraging preliminary clinical and translational data. Second, in September, we reported that the independent data and safety monitoring committee overseeing the study had reviewed all safety data to date and recommended that the study continue without modification, identifying no new safety signals and confirming comparable safety across both treatment arms.

That recommendation matters for a specific reason. The MRD study has now demonstrated the safety and tolerability of IMNN-001 both in combination with bevacizumab and used in the maintenance setting. These are two distinct safety objectives in two settings we had not previously characterized. This 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 reach the study’s primary assessment at second-look laparoscopy, treatment with IMNN-001 was associated with a lower rate of MRD positivity compared to the control arm, 44.4% vs 66.7%, higher clearance of circulating tumor DNA, 87.5% vs 62.5%, and a higher proportion of patients achieving no evidence of disease following frontline therapy, 100% versus 56%.

While these are preliminary findings from a small cohort, they provide encouraging evidence of a deeper antitumor activity induced by IMNN-001 at R0 day. We also presented recurrence-free survival for the MRD trial from the intent-to-treat cohort, where median recurrence-free survival was approximately twice as long in the IMNN-001 arm, 26.1 months versus 11.4 months. I would underscore again that this is a 26-patient intent-to-treat cohort and the log-rank p-value was 0.17.

This is a hypothesis-generating, not a confirmatory, study. Ovation 3 is the confirmatory study, but this trial provides evidence from an independent trial that is directionally consistent and contains novel biomarker data that shows tumor microenvironment remodeling — something that clinicians outside the company continue to remind me has long been a sought-after goal and is thought to be the holy grail in immune drug development for ovarian cancer.

The translational analyses continue to support IMNN-001’s proposed mechanism of action. We observe robust IL-12 expression within macrophages, activation of downstream cytokines including interferon gamma, and evidence of both macrophage and T-cell activation consistent with remodeling of the tumor microenvironment from an immunologically cold state to one that is immunologically active, or hot. This spatial and immune profiling identified macrophages as the principal cells taking up IMNN-001 in peritoneal fluid and tumor tissue and showed expansion of T-cell receptor clones consistent with the induction of anticancer immunity.

Finally, these encouraging biological and clinical findings continue to be accompanied by a highly favorable safety profile. Across the MRD study, 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 previously associated with interleukin-12–based therapies. This work builds on the foundation established by Ovation 2, which demonstrated a 14.7-month increase in median survival, 45.1 months versus 30.4 months, and a 24.2-month increase in median survival among patients who received PARP inhibitor maintenance, 65.6 vs 41.4 months, with none of the systemic dose-limiting toxicities that closed earlier interleukin-12 programs. It is worth noting how the overall survival signal behaved as the data matured.

At the July 2024 readout, the difference in medians was 11.4 months. At the final analysis in December 2025, it was 14.7 months. The benefit widened rather than eroded. I would also note that Ovation 2 was not powered for overall survival, which is precisely why overall survival is the primary endpoint in Ovation 3. For completeness, the 95% confidence interval around that 14.7-month difference runs from minus 3.8 to 33.3 months, with a one-sided p-value of 0.06.

In a study of this size, that is what a consistent, meaningful survival signal looks like without the statistical power to confirm it. These data have been published in Gynecologic Oncology and were presented at ASCO in 2025. In addition, in July we presented translational and clinical data from IMNN-001 at the inaugural AACR Conference on Drug Discovery and Development. Being included in this first edition of that meeting alongside technologies the organizers identified as those shaping the future of cancer drug development is a form of recognition we do not take for granted. We also presented additional translational data at the Society for Immunotherapy of Cancer meeting in November, and we plan to submit the final Ovation 2 overall survival analysis at a major medical meeting in 2027.

I’ll now hand the line back to Stacy.

Stacy Lindborg (President and CEO)

Thank you. Before I close, I want to spend a moment on how we’re running the business because in a company our size, capital allocation is strategy. Every decision we make is measured against one question: Does this advance Ovation 3 faster or more efficiently, or both? If it does not, we do not do it. The ThermoDox Agreement and the September exchange are both answers to that question. That discipline extends to how we pay ourselves. Members of our leadership team, the broader employee base, in addition to consultants, have voluntarily elected to take a meaningful portion of their base salary in stock rather than cash. This conserves cash for the trial and also, and very importantly, aligns management compensation with shareholder interest.

You’ve also seen that discipline on the expense line. General and administrative expenses have remained essentially flat year over year in the first three quarters of 2026 while we’ve been running a Phase 2 trial and a Phase 3 trial, and Josh will take you through that detail in a moment. None of this is a substitute for the capital this program ultimately requires, but it determines how far every dollar goes until we get there. Taken together, the June financing, the September debt-for-equity exchange, and the ThermoDox Agreement reflect a consistent approach: fund the Phase 3 trial, minimize dilution and overhang for existing shareholders, and convert non-core assets into potential future value rather than carrying them.

We have also been clear that completing Ovation 3 requires additional capital. That has been consistent in our filings and it remains the case today. Late last month we filed a registration statement with the SEC relating to a proposed offering of our securities. Because that registration statement is on file, I’m not going to discuss the proposed offering on this call beyond what it contains, and I would direct you to the filing itself for the terms.

What I will say is this: Patients don’t have time to wait, and we know that investors are also seeking value near term. Ovation 3 protocol includes two preplanned, event-driven interim analyses that could, if the pre-specified statistical thresholds are met, support an earlier registration submission. We also expect to provide regular operational updates on site activation and enrollment as well as additional translational and clinical data from our ongoing studies.

As those data mature, the National Cancer Institute is taking Imunon 001 into additional indications at its own cost. We’ve taken ThermoDox off our plate and reduced debt without issuing common stock. Every one of those actions was taken to make this program more fundable, and that work continues. With that, let me turn the call over to Josh to review our financial results. Josh.

Josh Blacher (Chief Financial Officer)

Thank you, Stacy, and good morning everyone. Details of Imunon’s third quarter 2026 financial results are included in the press release we issued this morning and in Form 10-Q we filed before the market opened this morning. Research and development expenses for the third quarter were 1.8 million, largely unchanged from 1.9 million for the same period last year. General and administrative expenses were 1.7 million, also largely unchanged from 1.6 million a year ago.

Non-operating expenses for the third quarter 2026 totaled 302,000, which largely relates to financing costs of our debt and equity extinguishment of a portion thereof. This compares to a de minimis amount of non-operating income for the corresponding period last year. Net loss available to common shareholders for the third quarter was 3.8 million, or $0.64 per share, compared with a net loss available to common shareholders of 3.4 million, or $1.16 per common share in the third quarter of 2025. Net cash used in operating activities for the quarter was 3.2 million. For the nine months ended 9-30-2026, net cash used in operating activities was 10.2 million. At 9-30-2026, we had cash and cash equivalents of 4.0 million.

In addition, we held 5.0 million of restricted cash in connection with the June financing. As disclosed in our filings, there is substantial doubt about our ability to continue as a going concern, and our independent registered public accounting firm included a going concern explanatory paragraph in its report on our financial statements. Addressing that is the purpose of the capital-raising activity to which Stacy referred. With that, I’ll turn the call back over to Stacy.

Stacy Lindborg (President and CEO)

Thank you, Josh. And with that, operator, please open the line for questions.

Bella (Conference Operator)

At this time I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Jason McCarthy with Maxim Group. Your line is now open. Please go ahead.

Jason McCarthy (Analyst)

Hi, guys. Thanks for taking the questions. Just wondering what you make of this sort of percolating activity we’ve been seeing in the IL-12 space, whether that’s, you know, Astellas’ preclinical licensing deal or Xilio’s upcoming Phase 2 data, and what that means for Imunon being the latest-stage program in the space.

Stacy Lindborg (President and CEO)

Yeah, thanks. Thanks for the question. I think the most obvious answer to that question is we’ve known that there has always been excitement about the potential of harnessing IL-12 as an immunotherapy. We see that in all of the historic trials, and we know that the challenges were never the biology. So I view this as a resurgence and an acknowledgement that we’ve been able to overcome the historic challenges, and we’re returning to the realization, which is clearly documented in the literature, that IL-12 is an incredibly powerful cytokine that activates both arms of the immune system and, if we can administer it safely, as we’ve been able to show in the case of Imunon 001, that is generating certainly excitement and interest in our discussions.

But it’s exciting to see the activity more broadly that you’re referencing. Douglas, I know that at SITC last weekend there was a second year of quite a bit of interest with IL-12. Maybe you want to make some comments just about your reflections there.

Douglas V. Faller (Chief Medical Officer)

I’d be happy to. So I attended the SITC meeting in Phoenix last weekend, and I presented some new translational data from the Ovation 2 trial which demonstrated remodeling of the patient’s tumor microenvironment from cold to hot by Imunon 001. One of the gratifying things to me was that there were a number of presentations using IL-12 as an anti-cancer therapeutic in either clinical or preclinical settings. Investigators and biopharma companies were employing various techniques to limit systemic exposure of interleukin-12, which we do very effectively, while still attempting to make it available to the tumor.

Most of these approaches involved direct injection into the tumor, and some included additional limitations on interleukin-12 availability and/or attempts to prolong its local activity because the protein is broken down very rapidly, and these included intratumoral activation of a pre-cytokine or incorporation into a polymer or expression from a virus. These were all in early stages of clinical development and usually focused on melanoma, where the tumor is readily accessible, or in dose ranging.

None of these pose any competition to Imunon 001. We’re years ahead in development of any of these programs and have already established a reassuring safety profile and demonstrated clinical activity in the randomized controlled trials, and we’re in an ongoing pivotal trial. But the renewed widespread interest and enthusiasm for interleukin-12 in the immuno-oncology environment really validates our program and our approach. And I will also say personally that as I went through the different IL-12 presentations and talked with the investigators, as soon as they realized I was from Imunon, they all wished me great success in our program because they thought that our success and our preeminent position in this area validates their activity. Stacy,

Stacy Lindborg (President and CEO)

Thank you.

Bella (Conference Operator)

Next question comes from the line of Kemp Dolliver with Brookline Capital Markets. Please go ahead.

Kemp Dolliver (Analyst)

Great. Thanks for taking my question or two. Just quickly, given some of the commentary regarding financing and what you have lined up with regard to site activations, how many more sites do you think you can activate with your current resources? Can you activate all up to 18 sites, or will you need additional capital to make more progress?

Stacy Lindborg (President and CEO)

Yeah, Kemp, it’s a great question. And we’ve been clear — in my prepared remarks, I offered this perspective as well. To complete our trial and also to complete and activate 50 sites, we require additional capital. This has been the case and, of course, as clearly shown in our filings, and we’re addressing that through the capital-raising activity, and that’s the purpose of our capital-raising activity. So we are actively working and enrolling sites, and we’re ensuring that we bring capital in that’s required for us to continue along this path.

Kemp Dolliver (Analyst)

Okay. And is there a deadline with the ThermoDox transaction in terms of their ability to raise the 2.5 million and close the agreement?

Stacy Lindborg (President and CEO)

There is not a deadline. And I think that when we ultimately reflect on a motivated partner, this is the source of advancing their company. We know there’s a lot of motivation with them. We obviously are excited at the potential of a technology and a product that we still believed in, so we’re delighted to see their progress, but we have not put any kind of artificial deadline around that.

Kemp Dolliver (Analyst)

Great. Thank you. Those are my questions.

Stacy Lindborg (President and CEO)

Thank you, Kemp.

Bella (Conference Operator)

Again, if you would like to ask a question, press star one on your telephone keypad. That concludes our Q&A session. I will now turn the call back over to Stacy Lindborg for closing remarks.

Stacy Lindborg (President and CEO)

Thank you. Just a couple of remarks, really. Reflecting back on our last call, I said that our clinical data were strengthening, our enrollment was strong, and our external validation was growing. And when we reflect on this quarter, each of these moved from assertion to evidence. The National Cancer Institute selected Imunon 001 as the first gene-based immunotherapy for partnered clinical development under a CRADA. Our independent data monitoring committees reviewed all safety data in the MRD study, and a separate independent data monitoring committee reviewed Ovation 3 data earlier this year, and both recommended continuation without modification.

And independent investigators presented the full clinical case for our R&D Day in September. We also sharpened the portfolio through the ThermoDox Agreement and strengthened the balance sheet through the debt-for-equity exchange, both without issuing common stock or warrants. We recognize there’s still important work ahead, but we believe the foundation we’ve built leaves us well positioned for the next stage of development. Our priorities are clear: advance Ovation 3 towards 50% enrolled in the first quarter of 2028 and completion of enrollment in the first quarter of 2029; support the National Cancer Institute as it initiates work under the CRADA; complete the ThermoDox transaction; and fund the program in a way that protects its shareholders — our shareholders.

All of this serves one end, which is delivering a much-needed treatment option to women with advanced ovarian cancer. For those who were not able to join us in September, I’d again encourage you to watch the R&D Day replay on our website. It is the most complete articulation of this program that we’ve put in the public. Lastly, I want to thank our employees, our investigators, and the women who have chosen to participate in these trials. And I want to thank our shareholders for their continued confidence.

Thank you for joining us today.

Bella (Conference Operator)

That concludes today’s call. Thank you all for joining. You may now disconnect.

Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.