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Good morning. My name is Tina, and I will be your operator today. At this time, I would like to welcome everyone to the Imunon First Quarter 2026 Final Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speaker's remarks, there will be a question-and-answer session. You may press star one on your telephone keypad to ask a question at that time. Please keep in mind, if you are using a speakerphone, you must release your mute function to allow the signal to reach your equipment. Again, that is star one to ask your question during the Q&A session. I would now like to turn the call over to Brandon Weiner of ICR Healthcare Investor Relations. Representatives of Imunon, please go ahead.

Thank you. Good morning, everyone, and welcome to Imunon's First Quarter 2026 Financial Results and Business Update Conference Call. During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed. Actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, May 12, 2026. Imunon undertakes no obligation to revise or update comments made during this call, except as required by law.

With that said, I would like to turn the call over to Dr. Stacy Lindborg, Imunon's President and Chief Executive Officer. Stacy?

Thank you, Brandon. Good morning to everyone joining us on the call this morning. Joining me on the call is Dr. Douglas Faller, our Chief Medical Officer, and Mr. Jeffrey Church, our Interim Chief Financial Officer, who will review our financial results for the first quarter of 2026. Mr. Michael Tardugno, the Executive Chairman of our board, is also on the line and will be available for Q&A. We've entered the second quarter of 2026 with continued momentum following what was truly a transformative year in 2025. We've made strong progress since our last conference call. We recently announced the final clinical data from our completed Phase II study, OVATION 2. IMNN 001, our proprietary IL-12 immunotherapy, continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer.

The pivotal phase III study, OVATION 3, is advancing well. We remain on track to randomize approximately 80 patients by the end of the first quarter of 2027. The capital funding environment has been challenging, not only for Imunon but also for the biotech sector generally. We continue to take steps to sharpen our focus on enrolling this important OVATION 3 study as rapidly as possible and to conserve cash. The reaction from the investment community to our progress and the data we have presented to date, including the results from our OVATION 2 phase II clinical study, has been very positive. Focusing now on our phase III study, we do understand that the primary challenge is the time it will take to fully enroll this 500-patient trial and to generate sufficient data for a future BLA filing.

Given the significant improvement in overall survival that we've seen in phase II and we expect to see in phase III, our primary endpoint, overall survival, is both a major strength and a practical time consideration. On one hand, overall survival remains the gold and definitive standard for demonstrating efficacy in oncology and would support a BLA filing based on a single pivotal trial. On the other hand, it requires some time for the data to mature and reach a formal readout, in fact, longer than some investors might prefer. We're solving this dilemma in two ways. First, through a disciplined bridge financing strategy that raises targeted capital to advance OVATION 3 and bring us closer to trial readout, positioning the company to attract new fundamental investors. Second, by structuring these financings in a creative manner designed to minimize dilution and limit pressure on Imunon's share price.

This could include the upside of a deal utilizing preferred shares, which are not immediately tradable, have no warrants with redemption at the market, and would also increase shareholder equity. This kind of a deal could compare favorably to registered direct deals that are typically dilutive and often include investors with little long-term interest in the company. We'll have more to say on this in the near future and we will provide updates as they become available. As always, our goal is to finance the company while not forgetting our shareholders and to keep a sharp focus on our North Star, which is bringing an innovative and much-needed new treatment option to women with advanced ovarian cancer. Our approach has always intended to be as investor-friendly as the options available to us permit.

Based on our unprecedented IMNN-001 clinical data thus far, we are confident that our program will attract investments from one or more strategic partners that is minimally dilutive or non-dilutive. Looking ahead, we are planning an R&D Day event in Q3 of 2026, I look forward to inviting you to hear from our Imunon team, trial investigators, and oncology experts on the value of our IMNN-001 program to clinicians and patients. The strong response from our current trial investigators, patients, and the broader medical community supports our belief in the significant potential of IMNN-001 to make a meaningful difference in women's lives. I know your attendance will be rewarded with the inspiring attitude of the physicians and scientists who are intimately involved with our unique proprietary DNA-mediated recruitment of the entirety of the body's defense against rogue malignancies.

Something that we have the pleasure of experiencing on a regular basis. I'll now turn over to Dr. Douglas Faller for clinical commentary. Douglas?

Thank you, Stacy. Building on your comments, the enthusiasm within the gynecologic oncology community continues to grow. Our phase II OVATION 2 clinical data showing a clinically meaningful 14.7-month median overall survival benefit with IMNN-001 treatment plus standard of care chemotherapy and the ability of IMNN-001 to activate both innate and adaptive immunity remains highly compelling to investigators. Our scientific presentations have reinforced IMNN-001's unique profile, localized IL-12 delivery with negligible systemic exposure, favorable safety, and clear signals of immune activation predictive of superior outcomes. In addition, we look forward to presenting the final OS results from OVATION 2 at an upcoming national conference. As Stacy also mentioned, we are thrilled to share that our next R&D day will be scheduled in Q3 2026.

This event will showcase the final efficacy analysis from OVATION 2, along with additional promising safety, efficacy, and translational data from our MRD study and new highly supportive translational data from OVATION 2. Building on the transformative clinical and translational results we have already reported in the public domain, these presentations will further highlight the significant potential of IMNN-001. I'm happy to say that investigators continue to proactively approach us about joining our phase III OVATION study. Study enrollment is progressing nicely and remains on track, with current sites performing well. Safety data remains clean and consistent with prior clinical results, including data from the ongoing phase II MRD study, which further support the favorable tolerability and unique mechanism of action of IMNN-001. These consistent findings give us high confidence as we advance the pivotal phase III trial. Back to you, Stacy.

Thank you, Douglas. Before turning to our financial update, I want to highlight that we remain focused on disciplined execution and strategic focus as we advance the most important development program in our company's history, IMNN-001, and of course, with our initial sites on ovarian cancer. Our multi-pronged financing strategy continues to balance the need to extend our cash runway while minimizing dilution and moving IMNN-001 forward as quickly as possible. Shareholder value remains paramount, and every decision is stress-tested against our commitment to fully fund the OVATION 3 study. Now over to Jeff Church for a review of our first quarter 2026 financial results. Jeff?

Thank you, Stacy. Details of Imunon's first 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. We continue to manage our cash position prudently through targeted financing activities, cost-saving initiatives, and operational efficiencies. Our disciplined approach, including the strategic reorganization announced earlier this year and the completion of the OVATION 2 study, supports our ability to advance the OVATION 3 study while extending our operating runway. Research and development expenses increased to $2.3 million in the first quarter of 2026 from $2.2 million in the same period last year. During 2025, the company initiated enrollment of the OVATION 3 study, and also in 2026, we've closed the OVATION 2 study.

General administrative expenses remained unchanged at $2.2 million in each of the first quarters of 2026 and 2025. Net cash used for operating activities was $4 million in the first quarter of 2026. This compares to $2.8 million in the comparable prior year period. This increase was largely due to the trial-related expenses associating with starting up the OVATION 3 study. With that financial review, I'll turn the call back to Stacy.

Thank you, Jeff. Tina, that concludes our prepared remarks. If you could open the call for questions.

Our first question comes from the line of Emily Bodnar with H.C. Wainwright & Co.. Please go ahead.

Hi. Good morning. Thanks for taking the questions. I noticed you gave initial guidance on enrollment completion for the first time. Maybe just kind of walk through what gives you confidence in this timing and how demand for OVATION 3 enrollment has kind of played into those assumptions.

Douglas, can you apprise us of our goals of fully enrolled?

Sure

when we expect all the trial to be fully enrolled and other reflections on the interest in the trial?

Yep, I'm happy to. Hi, Emily. Thanks for your question. We're enrolling 500 patients total, as you know, in our study, and we expect the last patient to be enrolled in Q1 2029. We are increasing the number of sites that we have activated, and that's been a push this year. We are expecting to have 80 patients enrolled approximately a year from now, as I think you know, which would be % of the total that we will enroll for the trial.

Great. Thank you.

Your next question comes from the line of David Bautz with Zacks Small-Cap Research. Please go ahead.

Hey, good morning, everyone. Thanks for the update today. Another question about enrollment. You've been indicating for a while now that enrollment has been, I guess, remaining ahead of schedule. I was wondering if you could just quantify that a little bit. Is this due to, you know, site efficiency? Is it investigator enthusiasm, patient demand? You know, what's kind of driving that?

Yeah, maybe I'll start, and Douglas, you can add. You know, trials always have a assumption of patients per site per month. When we look at, you know, early in a trial when you are starting with your early sites, we always have internal targets for by month, right? That we're hoping to accomplish. When we say we're ahead of target, it really reflects that by month, we've consistently had more patients enrolled than we were than our forecast. I think that, you know, as we ultimately set goals and it is very critical that we're completing the enrollment of this trial very expeditiously. You heard me reflect on our last earnings call that we were targeting this to be complete in the first quarter of 2029.

That then becomes our true target and it becomes critical that we're enrolling sites up to the number that we believe we need to be successful in doing this. I would say we're tracking very well with the process of now a brand new set of cohort of sites that are coming on board. You know, I'm really delighted by the early sites. These are obviously strong partners from OVATION 2. They know our product. They comment when we're with them in their centers of how visible it is to them when they're doing surgery on their patients, how different women who have been treated with Imunon look relative to the control.

Therefore, it's not surprising that some of these are substantially above the assumptions that we've made for the number of patients, you know, per site across the whole study. It's been quite remarkable, you know, from that viewpoint. Douglas, why don't you offer some additional perspective?

Well, I will echo what Stacy said and also just mention that we've been very gratified at the excitement and the number of patients some of the sites have enrolled upon just starting up. It's really a, I think, a testimony to the belief of our investigators in the potential benefit of IMNN-001 that they are very aggressively identifying patients who should benefit and talking with the patients and putting these patients on study. Again, just as Stacy has been pleased, our whole team, clinical team has been very happy with the strong engagement of the investigators and, as I said, in some cases, a flurry of activity as soon as their site is activated.

Okay. Great. Do you think this rate of enrollment has had any led to any increased collaborator interest at all?

Collaborator meaning partner, BD partner?

Yeah.

I don't think that's necessarily interacting in terms of those two streams. I do think that the counter would be true. If we are not successfully enrolling the trial, then you can expect that that would have a negative, you know, impact on BD and I'd say even investor, you know, investor interactions. I think that this really ultimately being able to describe, which Douglas has spoken of in the past, and I think could elaborate on if you'd like. You know, we continue to have sites that were not part of OVATION 2 that reach out, that are seeing our data presented in the scientific community.

When our paper came out with the, you know, the full publication from OVATION 2, we had outreach from centers, not just in the U.S., but in other parts of the world. That enthusiasm tied with, you know, the other aspect of the visibility that we've gotten in the medical community really speaks volumes, and I do think all of those positively impact, you know, all of our endeavors, partnerships, investors, et cetera.

Okay, great. Appreciate you taking the questions.

Thanks, David.

Your next question comes from the line of Jason McCarthy with Maxim Group. Please go ahead.

Hi, Stacy. Thanks for taking the questions. Could you It's more of a abstract question. Could you just review with us the powering assumptions around OVATION 3 and how many months OS you'd need to see? I know it's far off, but that interim data, sometime in, call it 2030 or so, is that expected to be blinded or unblinded in terms of sacrificing some of the power? More broadly, there's been an uptick in clinical trial activity around WEE1 inhibitors. There's new ADCs that have come after in HER2. There's been a lot of activity around the PI3Ks in different categories. How do you see the treatment landscape potentially shifting in ovarian cancer over the duration of the OVATION 3 trial potentially having an impact, positive or negative?

Those are great questions, Jason. Let me try to take them one at a time, and I think that I'll start with the first, the first two. Number one, it's an unblinded trial in the sense that the patients and the treating clinicians are unblinded. As you know, the reason for that is the insertion of a catheter really makes it unethical to run a blinded trial, which the FDA agrees with us on that front. We would not want to have to insert an unneeded catheter in the standard of care patients who are randomized to standard of care. That's separate from saying, is there structure and appropriate protection of the trial and integrity of the data that's occurring in the trial?

There are components of what we do that really we will be operating in a manner in terms of, you know, access to data unless it's truly needed for the job and would fit practices. We'll be acting in a manner as if it's, as if it's blinded internally. In terms of the assumptions, you know, we have continued to see the treatment effect grow across across the number of times that we refreshed the OVATION 2 data, then finally, of course, the final readout as we prepared and now have closed out the trial site. We saw the trial go from initially an 11-month improvement over the standard of care in overall survival, median overall survival, upwards to close to 15 months, which is really quite remarkable.

You know, you'll hear more from us in the future. We're really looking at how we can harness the final set of the data and how we can bring that to bear in terms of the Phase III trial and if in fact it would permit us to pull forward the final analysis. I would say it's early for us to talk about that, but it is something that we're carefully thinking through as any company would. When you have new information, you always want to make sure that your trial is really operating in the best information possible. The trial that we have described in the past, and this will continue, will have interim analyses.

We have two planned, right now they're designed to allow for an early stopping for efficacy that would occur about a year or a year and a half after the fully enrolled patients. The second would occur about a year later. I think that we'll be offering more guidance, you know, on this front. The last piece that in terms of the blinded and unblinded aspect, as we're ultimately talking to investors and thinking about how we can align a financing with long-minded investors that are really thinking about the course of this trial, we will have the ability to spread the amount that we will need to run the full trial really over the course of this trial.

One of the exciting aspects of the fact that it is an unblinded trial does permit us to allow for consideration of gaining and giving insight publicly into the secondary endpoint. To really build some confidence that we're observing secondary endpoints, which are all hard endpoints, pathological scoring and other such endpoints that were part of our OVATION 2 and really building a confidence that could de-risk financings and tranches, especially over time. Those are things that we're working through and have resonated well with our discussions with investors. On the front of the changes happening in the competitive landscape, Douglas, can you offer some perspective?

Sure. I'd be happy to, Jason. As a clinician, I'm very excited that there are second-line plus therapies being developed, including the ADCs you mentioned, and also, actually bare antibodies. The community's excited by this because we've been so limited in what we could provide patients second and third line and fourth line. While these are advances, I think one has to say that they are small advances. The benefits in terms of PFS, the benefits in terms of survival are poor, or let's say not terribly strong. We're talking months and they're certainly not curative, as you know. They are gonna be available for our patients second and third line, both the treatment arm and the control arm.

The implications on our study are really modest, I think. In addition, just to further emphasize the importance of frontline care, which is what we're delivering, even PARP inhibitors, which as maintenance have improved PFS in patients with frontline ovarian cancer, these are now being restricted more and more. The actual benefit of the PARP inhibitors, some of them have led to the FDA walking back some of the approvals. This doesn't affect our study. We're using PARP inhibitors as the FDA has suggested. It just to me further highlights the need for new and effective treatments up front, which is what we're delivering. The landscape for patients, second and third line has improved somewhat, maintenance perhaps less so.

We are in front of all of these things, and, we are hoping to reproduce the results we saw in OVATION 2, which are, not a few months benefit in survival but over a year in survival. That's our ambition.

Great. Thank you both for your answers.

Great. Thank you, Jason.

As a reminder, to ask a question, simply press star one. Our next question comes from the line of James Molloy with A.G.P. Please go ahead.

Hi, guys. Matt on for Jim today. Thank you guys for taking our questions, and congrats on the progress this quarter. Just a few from us. How should we expect the SG&A spend to look going forward given the recent reorganization? I have a follow-up on clinical.

Matt, it's a great question. Jeff, do you wanna cover just high level what we expect by quarter?

Right. Based upon our current projections after, you know, the reorganization that we implemented in the first quarter, we're looking at spends over the, over the next, you know, coming quarters in the four and a half to five million. We expect our G&A level to remain fairly consistent with where we were in the first quarter, but we would see an increase as we bring on more sites and enrollment starts to step up as it relates to the OVATION III study.

Matt, just to follow up, point to what Jeff just provided, you know, what we shared in terms of the strategic restructuring, there were positions eliminated, but there also were jobs that were redefined. A huge part of this is ensuring that not only our resources are being well-served, clearly we don't want to carry resources that are not directly contributing to our top priorities, but it also is really about making sure we can go as quickly as possible and that we're all focused on the launch of this phase III trial directly towards the completion and preparation for the commercial landscape, both on the manufacturing side and as we begin to prepare for the BLA.

Great. Thanks for that. Then in terms of just the kind of reorganization broadly at the FDA, have there been any discussions about, you know, utilizing some of these pathways like CNPV later down the line, accelerated approval as you guys get to the interim reads? How have those gone with this new kind of administration there?

Yes. Matt, I think that, you know, we've designed a really well-thought-out trial, which has always received very positive and professional engagement with the FDA. We, we've described over time, but it's, I never get tired of reflecting on, you know, the point that we got in writing from FDA that they had no safety concerns about the trial right around the time that we were finalizing the protocol and the end of phase II meeting. You know, we clearly understand that we've designed a trial that sets us up for filing if we're successful, if the trial meets the statistical thresholds. It's also under the agreement with the FDA. The interim analyses were a core part of the trial design and the analysis plan.

They are designed to allow for full approval of the group that's being analyzed in that, in that interim analysis, if we meet the threshold. You know, as with all phase III trials, you clearly outline what that threshold will be. We've used a very efficient alpha spending for the interim analyses. Probably that goes beyond what you're wanting to talk about, but that's something we care a lot about, is being very efficient and ensuring that we're giving enough of an opportunity to the interims, but then ultimately allowing the final analysis to really be set up very effectively. We're really not right now with this phase III trial focused on the idea of accelerated approval. We're focused on full approval.

I do think we'll keep line of sight, to ways and opportunities that maybe will allow, you know, additional interactions with FDA, maybe more accelerated, and higher priority, or if we reach a point in time where we want to formally engage FDA around programs that they're speaking about. Douglas, do you have anything you wanna add to that?

I just wanted to add one thing. As you know, Matt, accelerated approvals are usually based on early surrogate endpoints. The upheaval at the FDA and some of the decisions that they've made really don't affect us. We are looking at OS, and the FDA actually just recently issued a guidance saying for oncology trials, we want to see OS as the primary endpoint. That's always been our intention. That is how our trial is written, and we would not expect any surprises in taking an OS benefit to the FDA. It would be an oncology in all my years of experience, an OS benefit is never questioned. We won't have to deal with potential changes in what's expected by the FDA.

We have the gold standard and what they call the gold standard as our primary endpoint.

Great. Thank you guys for taking our questions, and congrats again on Q.

Thanks, Matt.

This concludes the Q&A portion of the call. I'll now turn the call back to Imunon's President and CEO for concluding remarks. Stacy?

Thank you all for joining the call. With our phase III trial OVATION 3, patient enrollment on track, the enduring strength of our phase II overall survival data and the compelling translational evidence and our sharpened financial discipline, Imunon is well-positioned for a value-inflecting milestone in 2026 and beyond. I wanna assure you we remain steadfast stewards of the resources you have entrusted to us and are fully committed to delivering a potential paradigm shift in ovarian cancer treatment while creating lasting shareholder value. Thank you for your continuing support.

This concludes today's conference call. You may now disconnect.

Please stand by. Good morning. My name is Desiree, and I will be your operator today. At this time, I would like to welcome you to Imunon's fourth quarter and full year 2025 financial results conference call. All lines have been placed on mute to prevent any background noise. Following the speaker's prepared remarks, there will be a question-and-answer session. You may press star one on your phone to ask a question at this time. Please keep in mind if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment. Again, that's star one to ask a question during the Q&A session. I would now like to turn the call over to Peter Vozzo of ICR Healthcare, investor relations representative for Imunon. Please go ahead.

Thank you, Desiree. Good morning, everyone, and welcome to Imunon's fourth quarter and full year 2025 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by the words such as expects, anticipates, believes, or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from those such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, March 31, 2026.

Imunon undertakes no obligation to revise or update comments made during this call, except as required by law. With that said, I would like to turn the call over to Dr. Stacy Lindborg, Imunon's President and Chief Executive Officer. Stacy?

Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Faller, our Chief Medical Officer, and Mr. Jeff Church, our Interim Chief Financial Officer, who likely needs no introduction given his tenure with Imunon. He'll be walking through and reviewing our financial results for the fourth quarter and full year of 2025. Mr. Michael Tardugno, the Executive Chairman of our board, is also on the line and will be available for Q&A. We entered 2026 with strong momentum following a truly transformational year in 2025. Our proprietary IL-12 immunotherapy, IMNN-001, continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer based on all available data thus far, both translational and clinical. IMNN-001 is rapidly advancing in the OVATION 3 pivotal Phase III study.

The urgency of this program remains front and center for our efforts to create value for our shareholders and to address the unmet need in ovarian cancer, which continues to claim far too many lives as the standard of care. Traditional chemotherapy in the frontline setting has not advanced in over 30 years. In our OVATION 2 study, IMNN-001 demonstrated the first-ever overall survival benefit in a randomized frontline clinical trial for this patient population, with a final overall survival readout showing continued improvement in median overall survival across the trial through three different analyses that were conducted. Starting first with the original Phase II clinical trial data readout in July 2024, which was across all endpoints. The median overall survival benefit was reported as 11.1 months. The median overall survival improvement observed in the subsequent clinical data readout in December 2024 was 13 months.

As we disclosed this week, has now expanded to 14.7 months in the final review of the trial results. Moreover, patients treated with PARP inhibitors as maintenance therapy, in addition to IMNN-001 and standard of care chemotherapy, demonstrated a median increase in overall survival of more than two years. The timing of this final analysis was defined in the protocol to occur when the last patient enrolled in the trial had reached three years post-treatment. These truly unprecedented Phase II results have given our laser-focused execution of the ongoing rigorous Phase III trial, which was as agreed to with FDA, is designed to confirm the Phase II results and support full regulatory approval.

Throughout 2025, we showcased the strength of these Phase II clinical data and the compelling translational insights at major scientific forums, highlighted by the platform presentation at the 2025 ASCO annual meeting and the simultaneous publication of the OVATION 2 study results in the peer-reviewed journal, Gynecologic Oncology. We capped off the year with a highly successful R&D day we hosted in November in New York City, and the investment community and leading clinicians heard directly from key opinion leaders about Imunon's ability to turn immunologically cold tumors hot, to remodel the tumor microenvironment and deliver meaningful clinical survival benefits to women with newly diagnosed advanced ovarian cancer where none had existed before.

This momentum carried into 2026 with OVATION 3 trial enrollment well ahead of plan. In a protocol that is virtually identical to the Phase II study, OVATION 3 is a one-to-one randomized trial to evaluate IMNN-001 plus standard of care neoadjuvant and adjuvant chemotherapy, which includes interval debulking surgery, versus the standard of care alone in women with treatment-naive advanced ovarian cancer. The adaptive trial design with interim analyses for early efficacy stopping rules provides 95% power on the primary endpoint of overall survival while offering the potential for accelerated timelines of a BLA for full approval. Key updates since our Q3 2025 conference call underscore the strength of our Phase II foundation and the accelerating progress in Phase III based on the strong response from patients, our clinical trial investigators, and the broader medical community. I'll just highlight a few areas, starting with site activation status.

Phase III trial enrollment remains strong with seven clinical sites actively enrolling patients and up to 43 additional high-quality centers under evaluation or in start-up mode. Returning investigators from the OVATION 2 study have been joined by new top-tier centers, many proactively reaching out following our data presentations and publications. We have contracted a global CRO to support rapid advancement of Phase III trial site activation and the study overall. Turning to enrollment velocity. Building on the strong progress we reported in late 2025, patient randomization and treatment in the Phase III trial have continued at an impressive pace, and enrollment remains ahead of plan. The early sites have delivered higher than the assumed rate of 0.3 patients per month, with some sites delivering as high as 1 patient per month.

This early momentum, driven by the compelling Phase II study overall survival benefit, positions us well for continued acceleration of site activation and patient enrollment. Our goal is to have approximately 80 patients enrolled in the trial within the next 12 months and enrollment completed in 2029. Turning to regulatory and design validation. Based on the FDA's endorsement of overall survival as the primary endpoint of the Phase III trial, combined with the robust statistical framework and precedent in oncology clinical drug development, OVATION 3 continues to de-risk the path to a potential regulatory approval in both the U.S. and Europe. On translational data and the MRD trial data, we have data from the ongoing Phase II minimal residual disease, or MRD study, in collaboration with Break Through Cancer.

This trial further reinforces IMNN-001 novel mechanism of action with demonstration of preferential uptake of peritoneal macrophages, profound tumor microenvironment remodeling, complete pathological responses, and durable IL-12 and interferon gamma expression with excellent tolerability, even in combination with bevacizumab. We've successfully capped our enrollment in the MRD study at 30 patients, allowing the trial to meet all core objectives and, upon completion, channel resources and highly productive sites fully into the Phase III OVATION 3 trial. Preliminary data from the Phase II MRD study continue to align with the overall survival benefits shown in the Phase II OVATION 2 study and support potential label expansions in the future. I'll now turn over the call to Dr. Douglas Faller for clinical commentary. Douglas.

Thank you, Stacy. The enthusiasm within the gynecologic community that we saw at our R&D day in November and throughout 2025 has only grown. The Phase II OVATION 2 clinical data showing a clinically meaningful 14.7-month median overall survival benefit and the ability of Imunon to activate both innate and adaptive immunity continue to resonate strongly with our investigators. Our multiple presentations at leading congresses in 2025 highlighted Imunon's unique profile, localized IL-12 delivery with negligible systemic exposure, favorable safety, and clear signals of immune activation predictive of superior outcomes. Interestingly, after seeing our data presentations, many investigators have been approaching us, asking us to join our Phase III OVATION study rather than vice versa. I find this kind of initiative to be most unusual in my long experience conducting clinical trials and also very gratifying.

It further supports the consensus of the significant potential of IMNN-001 to address the unmet medical needs in newly diagnosed ovarian cancer. OVATION 3 has leveraged this interest from day one. As Stacy said, study startup was completed in record time and early sites have exceeded enrollment forecasts. Safety data remains clean, mirroring the excellent tolerability seen across our IMNN-001 clinical programs. The Phase II MRD study has provided real-time confirmation of the favorable safety profile with no dose-limiting toxicities, no discontinuations due to IMNN-001, and very encouraging trends in progression-free survival and MRD negativity. These consistent findings across our studies give us high confidence as we scale the Phase III pivotal trial. Back to you, Stacy.

Thank you, Douglas. Before turning to our financial update, I want to highlight that 2025 was defined by disciplined execution and strategic focus. We advanced the most important development program in our history while navigating a challenging capital markets environment with prudence and foresight. Our multi-pronged financing strategy, combining targeted equity raises, opportunistic ATM usage, and ongoing partners and partnership discussions, has allowed us to extend our cash runway while minimizing dilution and advance IMNN-001 as quickly as possible. Shareholder equity remains paramount. Every decision is stress-tested against our commitment to fully fund the OVATION 3 study with like-minded investors. We're making solid progress on this front and believe that once we secure a lead investor, we will be able to assemble a syndicate quickly.

While the markets are improving and our ongoing calls with strong investors remain highly encouraging, we recognize that this process inherently takes time. We will continue to balance the ultimate goal of financing the trial with long-term oriented investors against the need to prudently extend our cash runway. We firmly believe that successfully completing this full financing is in the best interest of all of our constituents, including patients who are at the center of everything we do and all shareholders, as we believe this will enable our investors to realize significant value. We are encouraged by continued interests and potential non-dilutive partnerships for our TheraPlas technology platform and IMNN-001. On the financing side, prudent use of our ATM facility and warrant exercises supplemented our cash position in 2025.

Monthly cash usage has been further optimized, and we announced a strategic reorganization in February 2026 to reduce non-essential costs and to sharpen our operational focus exclusively on OVATION 3. Streamlining operations and focusing scientific leadership while preserving all critical expertise in the interest of all Imunon stakeholders. These actions, combined with our continued manufacturing and efficiencies, which are great, are designed to deliver on our milestone with maximum efficiency. Now over to Church for a review of our fourth quarter and full year 2025 financial results. Jeff?

Thank you, Stacy. Details of Imunon's fourth quarter and full year 2025 financial results were included in the press release we issued this morning and in our annual report on Form 10-K, which we filed before the market opened this morning. As of December 31, 2025, cash and cash equivalents were $8.8 million, reflecting disciplined cash management and net proceeds from warrant exercises and targeted ATM usage during the year. We project that this cash balance, together with our ongoing financial activities and cost-saving initiatives, extends our operating runway into the second half of 2026. Research and development expenses for 2025 were $7.8 million, which was significantly lower than twenty twenty-four, primarily due to the completion of the OVATION 2 study, optimization of the MRD study, and focused spend on the OVATION 3 study's manufacturing and startup activities.

General and administrative expenses were down 8% year-over-year through streamlined operations and renegotiated commitments. Net loss for 2025 was $14.5 million or $6.83 per share, compared to $18.6 million or $16.94 per share, reflecting meaningful improvement driven by our cost discipline. I just would like to remind everyone that all share and per share amounts reflect the 15-for one reverse stock split effective in July 2025 and the 15% stock dividend declared in the third quarter of 2025. With that financial review, I'll turn the call back to Stacy.

Thank you, Jeff. Desiree, with that, we'll open the call for questions.

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and 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 speakerphone in your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Again, press star one to join the queue.

Our first question comes from the line of Emily Bodnar with H.C. Wainwright. Your line is open.

Hi, Lauren. Thanks for taking the questions. My first one, have you presented the final data from OVATION002 to the FDA, particularly on the PARP inhibitor patient population? Have you received any feedback from the FDA on focusing on this patient population first in your OVATION003 study? Maybe if you could just kind of outline how you're thinking about upcoming milestones and catalysts for 2026 and any OVATION003 updates that you're considering for this year. Thanks.

Thanks, Emily. That's a very well-formulated and comprehensive question. Let me take it in steps. First, we have not presented the OS data to the FDA. You know, we are incredibly excited by the fact that it continued to improve. Really, this last analysis reinforces exactly the plans that we have in place. I think you specifically ask about the PARP-treated patients. You know, while this is even a larger effect than what we see in the intent to treat population, we know that this is a relatively small group in the trial, and it becomes important that we're replicating the findings. We will be presenting the data to the investor community, and we'll also be presenting it to the clinical community.

In fact, we got an abstract submitted over the weekend to a meeting that will really afford us to have some great discussions with potential new principal investigators. Our focus right now is really around the Phase III trial, ensuring that we're continuing to build the amazing momentum and excitement in the medical community around this data and then ultimately delivering on the trial. Maybe I'll stop there really quickly and see if there's anything else, Douglas, you want to add to the latest data.

Just that, although we're very excited about the results in the patients treated with PARP inhibitors, we're equally excited about the results that we see in the entire population. This greater than a year increase in survival is, as you know, Emily, unprecedented in ovarian cancer. No one has seen anything like this in the entire time I've been practicing medicine. The ability, as we replicate this in the Phase III, this will be incredibly meaningful for patients. The whole population of patients is what I'm getting at, not just the patients who receive PARP inhibitors. If they continue to benefit as much as they did in the Phase II, that's wonderful. We're focused on providing benefit to the entire population of newly diagnosed women with advanced ovarian cancer.

Thank you. Emily, if I remember correctly, the other questions were focused around upcoming catalyst and our plan for this year and beyond. You know, I would say that we have catalysts that we're going to be very excited to report back, one of them being around the momentum of the trial. You heard in my prepared remarks that our goal is to have 80 patients enrolled by this time next year. Reporting our momentum will be a very critical component of ultimately the overall timeline that we've been committed to. That will be one catalyst. We will continue to have presentations at medical and scientific congresses.

We have samples, tissue samples still from OVATION 2 that we intend to analyze and have in the near term a comprehensive analysis and publication around translational data that we think will really be very compelling for the scientific and medical community that will be able to go beyond what we've presented to date. I think that'll be a very meaningful contribution. We have the potential for partnership progress that may provide opportunities to extend the runway further. Of course, we are continuing with our strategic goal of financing the trial with long-minded investors. Those are all things that we're very actively involved with.

Our plans for 2026 really are going to be focused on our funding for the company, making sure we have the cash runway and that we are really increasing our institutional base in parallel. Second, enrolling the trial and ensuring that we're spending a lot of time with our partners that are involved in this trial and the broader medical community as we're really helping translate the value for women newly diagnosed and bringing forward a product that really should revolutionize the standard of care.

Perfect. Thank you.

Thank you, Emily.

Our next question comes from the line of James Molloy with Alliance Global Partners. Your line is open.

Hey, guys. Thank you very much for taking my questions. Could you walk us through now you gave your excellent guidance, a very clear guidance about 80 patients by this time next year and 2029 to complete enrollment of the trial. Could you walk us through what potential cut points for interim looks we might be able to anticipate going forward over the next 12 months?

Yeah. Great question, James. Thank you. The interim analyses which have been laid out are all very carefully designed through, you know, comprehensive simulations, which are always looking at the timeframe in which you might expect to be able to see a successful hit, if you will. A P value that would allow you to file your BLA. As you know, we've described this in the past, and we've had reviews of our protocol. We've designed these studies for there to be two. The important component, given what we know very well from the literature and other immuno agents, we need to observe patients long enough to be able to see events in the control arm for there to be really the ability to have success.

We've designed these interims to occur after the point that we would have fully enrolled the trial. We expect, based on the simulations that we've done in the past, that the first interim would occur about a year after that. That is what we're actively working towards. It's as always designed to allow for if we see a bigger effect than we have assumed in the protocol. This interim, in fact, the first interim would provide an opportunity for us to act more quickly than waiting. But it also is important that we're being very careful with these interims, and of course, because you're using type one error rate, as you're ultimately doing these formal analyses. That's kind of a bit of an insight into how we balance the various dimensions and what we can expect going forward.

Maybe a follow-up question on the final data on the OVATION 2 showing the excellent survival data. How did that change the potential partnership environment, if all you can share with us?

You know, it's obviously very early. We just released the data last week. We are participating tomorrow in the MedInvest Biotech & Pharma Investor Conference, and we are getting new inquiries that are occurring even as of this week. I expect that to continue to develop. These kinds of partnerships, whether they're geographic in nature or they're more fundamental with big pharma, really ultimately has to fit with a strategy and an interest and an intent from a timing standpoint. We're very pleased to see renewed and new inquiries.

Thank you for taking the questions.

Thank you.

Next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.

Hey, Stacy. Thanks for taking the questions. Going back to OVATION 2, is there gonna be an opportunity when you continue to mine that data? Will you have anything related to minimal residual disease or any second-look laparotomy looks for MRD, or any more immune data that might be suggestive of T-cell memory or something that's keeping these patients' disease kind of in check, and that could be driving these longer-term survivors?

Yeah. Maybe I'll start, and then I'd like Douglas to pick up. We won't have anything from OVATION 2 that relates to the minimal residual disease or second-look laparotomy because it's an additional procedure that is not part of standard of care, and therefore it wasn't implemented in OVATION 2, nor will it be implemented in OVATION 3. That is, you know, an exploratory, and it's an endpoint that I think has gotten a lot of interest as a potential predictor of overall survival that, you know, was incorporated into what we call the MRD study. The OVATION 2 won't give insights into that, but we will continue to contribute not only to our own learnings, but also the literature from that the trial that we're doing in combination with Break Through Cancer.

We do have other data that we'll be able to get from OVATION 2, and I'll let Douglas go into some of that.

Yeah. Excuse me. Yes. We've been over the last nine months or so, as you know and alluded to, we've been releasing more and more translational data, and we have additional translational data to present, and we're planning on publishing that also. This may include looking at peripheral responses in addition to the responses that we've shown so dramatically in the tumor and the tumor microenvironment. We're very excited about the translational data. Just to expand on what Stacy said, even though we call one of our trials MRD is not really officially established for ovarian cancer. There are no criteria that have been shown to be predictive of a patient's outcome.

The MRD study is an approach to start working on that, but that data has yet to evolve, and we will try to determine over time what the best approach to MRD might be for it to be predictive in ovarian cancer. It's something of great interest. This is in part why Break Through Cancer got involved in the MRD study because they also would like to be able to generate a test, like MRD, which could be predictive of patient outcomes. In addition, in our Phase III, we will be looking at circulating tumor D&A. This may end up being a marker for MRD. It's not established yet in ovarian cancer, but our trial might be one of the ones that could establish circulating tumor DNA as a predictive marker. That's yet to come.

Great. Thank you. Are there gonna be updates from the MRD study in 2026 that we could look towards as potential catalysts?

It's possible. I think that it will ultimately depend really on our interactions with the study PI, Dr. Amir Dazari. We know that he presented data that was very exciting to see, the analytical data, and he decided to really take a cohort of patients and analyze them together rather than continuing to analyze, you know, patients over time, individual patients over time. The clinical data, of course, will be continuing to evolve. You know, we're in early discussions with him around where we may present that in the medical community, and we'll be thinking very much about bringing forward insights. It'll be an exciting other arena for information.

The last question, I don't know if I'm overlapping with James had asked previously about enrollment timing. When you get to the 80, are you going to release any details on the HRD status of the patients just so people can get a sense of the percentages that are in the trial or may be in the trial?

It's an interesting question. I think right now, you know, and if I just step back and I look at what we've learned with this final analysis, you know, the overall effect that we've observed in the all-comers population has continued to grow so substantially that, you know, while the underlying genetics, which right now plays a critical role in the maintenance therapy and become central to how the treating community is taking care of patients. What's interesting is that our principal investigators are probably as excited about the effect in the HR-proficient patients as they are in the HRD-positive. It will continue to be a very interesting and important part of our Phase III trial.

I think that we will really be looking holistically at the full trial and be very excited because we're able to influence and extend the life of an all-comers population. It's that. That's my thinking of this. I think that we'll have to think very carefully about the exposure, you know, that we give to an ongoing Phase III trial. It's an open label trial, and we'll have the ability where we find it important from an investor standpoint to think about maybe secondary endpoints and provide updates. Those will be taken with great caution just to preserve the integrity of the trial. Douglas, anything more?

Yeah. The only thing I wanted to add is although this is an open label study, because to preserve data integrity, we in the company are blinded in terms of efficacy, not safety, but efficacy. We will not even ourselves be seeing the efficacy data as the trial progresses in terms of the primary endpoint.

Just a hypothetical. I'm not sure if you'd have the answer for this or not. There is a trial that's gonna read out in the second half of this year for an oncolytic virus in a relapsed refractory setting for PROC for ovarian cancer that the expectation is that it can resensitize to platinum. So for chemotherapy, it suggests that if they're successful, that it could change the standard of care potentially even in the neoadjuvant setting. I'm bringing it up because this trial is gonna take a long time. OVATION 3, and if you've thought about how some potentially new therapies that could be on the market could influence how patients are managed by the time you get to the OVATION 3 full top-line data.

Thank you for that question. We're certainly very aware of the drugs that are being developed in the relapsed refractory space, both platinum sensitive and platinum resistant. The most patients, interestingly, their tumors are sensitive to platinum. The idea that you'd have to sensitize patients in the neoadjuvant setting or the adjuvant setting really is not something that is at all mainstream. Most patients do respond to chemotherapy. Unfortunately, durable responses are rarer, and then you get into second- and third-line treatments. As you know, there have been at least one and soon two drugs approved in different settings in second-, third-, fourth-line patients who are not being treated with platinum again. That's wonderful.

We're very happy that there are drugs that provide a bit of a survival benefit in second or third line. As we all know on the phone and in this call, putting the best therapy up front and making the biggest impact on the tumor is critical if you're going to treat ovarian cancer successfully. We're very happy to be in front line, very proud of the fact that we're in front line, and we believe that we will be providing advantage over time in terms of increases in survival to the patients we're treating.

Got it. Thank you for taking all the questions.

Thank you, Jason.

You're welcome.

Next question comes from the line of Kemp Dolliver with Brookline Capital Markets. Your line is open.

Great. Thank you for taking the questions. First, are the savings from the restructuring of any significance that we would see the impact of them in the first half of this year?

Kemp, really what we reported as a strategic restructuring really is around ensuring that we're using all of our resources to the best of our ability and focused on Phase III. You know, we're ensuring that we have the ability to hire and bring in needed expertise for the future as we're thinking about the commercial setting, and we're looking, you know, to the upcoming year and beyond.

It really is not about a pure number, but it is about just an ongoing evolution of making sure that we're taking the talent we have in-house, that we're focusing our attention for each person, you know, to ensure that we're bringing the most value possible and that we're really removing anything that is off target from the OVATION 3, which is our sole focus right now.

Okay. Thank you. You know, with regard to your commentary regarding the pace of enrollment at the site level, I'm gonna split a hair if I can, 'cause it may be informative. Is that pace increasing, say, month-to-month, or has it just been consistently above your forecast?

You know, we only have, of course, the timeframe from the very first patient to now. But we see that for the entire trial, we are above the assumption of 0.3 points per month per site. If you look across all the sites, the average is above that. When we you know the numbers that I was reporting of these sites that actually are delivering one patient per month or even just slightly below, that is across the whole time period that they're delivering. I do think you tend to see kind of episodic enrollment that can happen, but the numbers that we're reporting are not singular months. They're summarizing the entire time thus far.

I do think we're hearing phenomenal, you know, feedback. We're spending time in our sites that are actively enrolling patients. We're having calls regularly as well. These conversations in terms of the data. You know, we get to see a broader set of the community. For example, with the abstract we were putting in over the weekend, you know, you have quite a few PIs that were part of OVATION 2. They all got to be on this abstract and to see the excitement in their responses, gratitude for being included and really just, you know, pure excitement with the data. Douglas, why don't you comment more?

No, it's exactly right. This is the first time that they had seen the final data in terms of survival, and there was a great deal of enthusiasm, as you might expect. They were very happy that their patients have seen this much benefit.

We really think this will be a difference maker for OVATION 3 compared to OVATION 2. You know, going into OVATION 2, we had a lot of promise. We had a mechanism of action that made a lot of sense, you know, very clearly established in the literature. Phase III now we have evidence of a clinical effect that's never been seen, and we continue to really hear that that becomes very critical. You know, we can actually see the numbers that are entering pre-screening, and we see a very, you know, high rate ultimately coming through to randomization, with really the exceptions being things like, inclusion criteria not met. That will always be the case. Or, you know, inability, you know, perhaps somebody that's traveled a very long way and doesn't feel like they can make the schedule.

Really, the rate of being exposed to this potential, you know, the way that one of our PIs who's been involved with our program for a long time, you know, talks about this with patients is, "You're going to get the standard of care which you'll get in this trial if you do not have interest in research and in this protocol. If you want to consider being in this protocol and if you're randomized to the experimental arm, then you have a chance at a product that may extend your survival." It's been a very straightforward discussion as they're describing it to us and we're getting, as we might expect, a positive response from patients and from the sites.

Great. Thank you.

Our last question comes from the line of David Welch with Wolfe Capital Research. Your line is open.

Hey, good morning, everyone. Thanks for the overview this morning. I just have a couple of financial questions. As resources become available, is the company gonna look to open additional sites in the U.S. or are you looking ex-U.S. to get any international sites open? As far as payments for the Phase III trial, I guess I'm just trying to look ahead, you know, how is it being paid for? You know, did you have a bullet payment up front? Is it pay-as-you-go? Like, how is it structured?

David, great questions. I was having a little trouble hearing you, so let me respond to your questions, and if I don't hit on them, we'll have you ask further. We are actively enrolling and accelerating the enrollment of trials. Right now those are focused in the U.S., although we have sites in Canada that we know are very interested, and we have had conversations as we're looking to consider you know the strategy of if we want to accelerate further adding a European country as well. We've already had some discussions with leading sites in central Europe. That's a conversation that we expect to advance over the next year.

Right now, we believe that we'll be able to meet our enrollment accelerations, and we have a lot of confidence with the sites that we're going after and we're starting with in the U.S. We think that's actually the best way to start. In terms of payments for the trial, you know, these trials are structured. This trial is structured pretty traditionally. You have contracts with individual sites. There are start-up fees and then fees as patients are being treated as part of the protocol.

We have an ability to take advantage of what is standard of care and to have that be paid through the traditional routes and some of the procedures not be due to be paid by Imunon, and we've taken full advantage of that to really structure the contracts accordingly.

Okay, great. Appreciate you taking the questions.

Thank you, David.

This concludes the Q&A. I'll turn the call back to Dr. Lindborg for closing remarks.

Thank you, Desiree, and thank you all for joining this call. With the Phase III study enrolling ahead of plan, as we've just been talking about, the enduring strength of our Phase II overall survival data and the compelling translational evidence that Douglas spoke about and our sharpened financial discipline, we really know that Imunon is well-positioned for milestones that will create value inflection in 2026 and beyond. We remain steadfast stewards of the resources you have entrusted to us and are fully committed to delivering a potential paradigm shift for ovarian cancer treatment while creating lasting shareholder value. We thank you for your continued support and look forward to future calls.

Ladies and gentlemen, that concludes today's call. Thank you all for joining in. You may now disconnect.