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. I would now like to turn the call over to Peter Vozzo, the 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 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 of 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. And as we disclosed this week, it 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, and these unprecedented Phase II results have given us laser-focused execution of the ongoing rigorous Phase III trial, which was as agreed to with the 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 Gynecological Oncology. We capped off the year with a highly successful R&D Day we hosted in November in New York City, where 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 1:1 randomized trial to evaluate IMNN-001 plus standard-of-care neoadjuvant and adjuvant chemotherapy, which includes interval debulking surgery, versus 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 for a BLA for full approval. Key updates since our Q3 2025 results 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 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-assumed rates of 0.3 patients per month with some sites delivering as high as one 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 a robust statistical framework and precedent in oncology clinical drug development, OVATION 3 continues to de-risk the path to 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 Breakthrough Cancer Foundation. This trial further reinforces IMNN-001's novel mechanism of action with demonstration of preferential uptake by 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 benefit shown in the Phase II OVATION 2 study and support potential label expansions in the future. I'll now turn the call over 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 to join our Phase III OVATION study rather than us recruiting them. I find this initiative most unusual in my long experience conducting clinical trials and also very gratifying. It further supports a consensus of significant potential for 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 start-up was completed in record time and early sites have exceeded enrollment forecasts. Safety data remain 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 multipronged financing strategy, combining targeted equity raises, opportunistic ATM usage and ongoing 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 long-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 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 interest in potential nondilutive 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 nonessential costs and to sharpen our operational focus exclusively on OVATION 3, streamlining operations and concentrating scientific leadership while preserving all critical expertise in the interest of all Imunon stakeholders. These actions, combined with our continued manufacturing efficiencies, are designed to deliver on our milestones with maximum efficiency. Now over to Mr. 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 uses 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 2024, primarily due to the completion of the OVATION 2 study, optimization of the MRD study and focused spend on the OVATION 3 study manufacturing and start-up 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 would like to remind everyone that all share and per-share amounts reflect the 15-for-1 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.

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

My first one, have you presented the final data from OVATION 2 to the FDA, particularly on the PARP inhibitor patient population? And have you received any feedback from the FDA on focusing on this patient population first in your OVATION 3 study? And then maybe if you could outline how you're thinking about upcoming milestones and catalysts for 2026 and any OVATION 3 updates that you're considering for this year?

Thanks, Emily. Let me take that in steps. First, we have not presented the overall survival data to the FDA. We are incredibly excited that it continued to improve, and this last analysis reinforces exactly the plans we have in place. You specifically asked about the PARP-treated patients. While this is an even 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 is important that we replicate the findings. We will be presenting the data to the investor community and to the clinical community. In fact, we submitted an abstract over the weekend to a meeting that will afford us the opportunity to have discussions with potential new principal investigators. Our focus right now is around the Phase III trial—ensuring that we continue to build momentum and excitement in the medical community around this data and ultimately deliver on the trial. Douglas, is there anything 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 unprecedented in ovarian cancer. No one has seen anything like this in the entire time I've been practicing medicine. The ability to replicate this in the Phase III will be incredibly meaningful for patients; our focus is on providing benefit to the entire population of newly diagnosed women with advanced ovarian cancer, not just the patients who received PARP inhibitors.

Thank you. Emily, if I remember correctly, your other questions were focused on upcoming catalysts and our plans for this year and beyond. We have catalysts that we expect to report on, one being momentum of the trial. As I said in my prepared remarks, our goal is to have 80 patients enrolled by this time next year, and reporting enrollment momentum will be a critical component of the overall timeline. We will continue to present at medical and scientific congresses. We have tissue samples from OVATION 2 that we intend to analyze and prepare a comprehensive publication around translational data in the near term that we think will be compelling for the scientific and medical community. We have potential partnership progress that may provide opportunities to extend the runway further. And, of course, we are continuing with our strategic goal of financing the trial with long-minded investors. Our plans for 2026 are focused on funding the company, ensuring we have the cash runway and increasing our institutional investor base in parallel, and enrolling the trial while working closely with our trial partners and the broader medical community to translate the value for women newly diagnosed and bring forward a product that could revolutionize the standard of care.

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

Could you walk us through— I know you gave clear guidance on 80 patients by this time next year and 2029 to complete enrollment of the trial—what potential cut points for interim looks we might be able to anticipate over the next 12 months?

Great question, James. The interim analyses have been carefully designed through comprehensive simulations, which consider the time frame in which you might expect to see an efficacy signal sufficient to support a filing. We've described this in the past and had reviews of our protocol. We've designed two interim analyses. Given what we know from the literature and other agents, we need to observe patients long enough to see events in the control arm for there to be the ability to have success. These interims are designed to occur after we have fully enrolled the trial. Based on our simulations, the first interim would occur about a year after full enrollment. If we see a larger effect than assumed in the protocol, the first interim could provide an opportunity to act more quickly than waiting, but we are being careful with these interims because of the type I error rate used in formal analyses. That gives some insight into how we balance the dimensions and what to expect going forward.

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

It's early, as we released the data last week, but we are getting new inquiries, including this week. We'll be participating tomorrow in the MedInvest Biotech & Pharma Investor Conference, and I expect interest to continue to develop. Partnerships, whether geographic or strategic with larger companies, must fit timing and strategy. We're pleased to see renewed and new inquiries.

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

Going back to OVATION 2, will there be an opportunity as you continue to mine that data to report anything related to minimal residual disease or any more immune data that might be suggestive of T-cell memory or something keeping these patients' disease in check that could be driving these longer-term survivors?

We won't have OVATION 2 data related to minimal residual disease or second-look laparoscopy because those procedures are not part of standard of care and were not implemented in OVATION 2 nor will they be in OVATION 3. The MRD study is an exploratory approach to investigate MRD as a potential predictor of overall survival. OVATION 2 will provide other translational insights, and I'll let Douglas go into more detail on that.

Over the last nine months we have been releasing increasing amounts of translational data, and we have additional translational data to present and plan to publish. This may include looking at peripheral responses in addition to the dramatic responses we've shown in the tumor and the tumor microenvironment. MRD is not yet officially established for ovarian cancer; there are no criteria proven to be predictive of outcome. The MRD study is an attempt to work on that. Breakthrough Cancer Foundation partnered on the MRD study to help generate a test that could be predictive of patient outcomes. In our Phase III, we will be looking at circulating tumor DNA, which may end up being a marker for MRD. It's not established yet in ovarian cancer, but our trial might help establish circulating tumor DNA as a predictive marker.

Great. Are there going to be updates from the MRD study in 2026 that we could look toward as potential catalysts?

It's possible. It will depend on our interactions with the MRD study principal investigator, Dr. Amir Jazaeri. He presented analytical data and decided to take a cohort of patients and analyze them together rather than continuing to analyze patients individually over time. The clinical data will continue to evolve. We're in discussions about where to present that in the medical community and will be thinking carefully about bringing forward insights. It will be an exciting arena for information.

When you get to 80 patients, are you going to release any details on the HRD status of the patients so people can get a sense of the percentages in the trial?

It's an interesting question. The overall effect we've observed in the all-comers population has continued to grow substantially, and while underlying genetics play a critical role in maintenance therapy and how the treating community cares for patients, our principal investigators are as excited about the effect in homologous recombination-proficient patients as they are in HRD-positive patients. This will be an important part of our Phase III. We will look holistically at the full trial. Because OVATION 3 is an ongoing open-label trial, we will be careful about the exposure we give to trial data to preserve integrity. We may provide updates on secondary endpoints where important from an investor standpoint, but we will do so with great caution.

Although this is an open-label study, to preserve data integrity, we and the company are blinded with respect to efficacy, not safety. We will not be seeing efficacy data as the trial progresses in terms of the primary endpoint.

Just a hypothetical: there is a trial readout in the second half of this year for an oncolytic virus in the relapsed/refractory setting for platinum-resistant ovarian cancer that could resensitize to platinum. If they are successful and that changes the standard of care, could that influence how patients are managed by the time you get to OVATION 3 top-line data?

We are aware of drugs being developed in the relapsed/refractory space. Most patients' tumors are sensitive to platinum. The idea that patients would need to be sensitized in the neoadjuvant or adjuvant setting is not mainstream. Most patients respond to chemotherapy, but durable responses are rarer and second- and third-line treatments follow. There have been drugs approved in later-line settings that provide survival benefit, which is welcome. Putting the best therapy upfront and making the biggest impact on the tumor is critical for successful treatment of ovarian cancer. We're proud to be in the frontline setting and believe we will provide a survival advantage to the patients we treat.

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

First, are the savings from the restructuring of any significance that we would see the impact of in the first half of this year?

Kemp, what we reported as a strategic restructuring is about ensuring we use our resources to focus on Phase III. We're ensuring we have the ability to hire and bring in needed expertise for the future as we think about the commercial setting, and we're aligning our team to maximize value. It is not about a single headline number; it is an ongoing evolution to focus attention on OVATION 3, which is our sole focus right now.

With regard to your commentary on the pace of enrollment at the site level, is that pace increasing month-to-month or has it just consistently been above your forecast?

We have only the time frame from the first patient to now, but for the entire trial the average is above the assumption of 0.3 patients per month per site. The numbers I reported for sites delivering one patient per month or slightly below summarize the entire time they've been enrolling. Enrollment can be episodic, but the numbers reported are not singular months; they summarize the entire period thus far. We hear phenomenal feedback, and we spend time with sites that are actively enrolling patients. We have calls regularly and see a broader set of the community engaging with our data. Many PIs who were part of OVATION 2 are excited and grateful to be included, which is reflected in the prescreening activity and the high rate of conversion to randomization aside from typical exclusion criteria or logistical issues for patients. Douglas, would you comment?

That's exactly right. This was the first time many investigators had seen the final survival data, and there was a great deal of enthusiasm. They were very happy that their patients have seen this much benefit.

We think this will be a difference maker for OVATION 3 compared to OVATION 2. Going into OVATION 2, we had a lot of promise and a mechanism of action that made sense. Now, with evidence of a clinical effect not previously seen, we continue to hear that this is critical. We can see the numbers entering prescreening and a high rate coming through to randomization. Exceptions are inclusion criteria not met or patients unable to commit to the schedule, which will always occur. One of our long-time PIs describes the trial to patients as receiving standard of care regardless of arm, but if randomized to the experimental arm, they have a chance at a product that may extend survival. That straightforward discussion yields positive responses from patients and sites.

And our last question comes from the line of David Bautz with Independent Research.

I have a couple of financial questions. As resources become available, will the company open additional sites in the U.S., or will you look internationally to get sites open? And with regard to payments for the Phase III trial, how is it being paid for? Did you make bulk upfront payments, or is it pay-as-you-go? How is it structured?

David, great questions. We are actively enrolling and accelerating enrollment, focused in the U.S. right now, although we have interested sites in Canada and have had discussions about adding European countries if we want to accelerate further. We expect to advance that conversation over the next year, but we believe we'll be able to meet our enrollment with the U.S. sites we are starting with. In terms of payments, the trial is structured traditionally with contracts with individual sites, start-up fees and fees as patients are treated per protocol. We're taking advantage of procedures that are standard of care to have those paid through traditional routes rather than by Imunon, and we have structured site contracts accordingly.

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, the enduring strength of our Phase II overall survival data and the compelling translational evidence that Douglas spoke about, together with our sharpened financial discipline, we believe Imunon is well positioned for milestone-driven 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.