3/31/2026

speaker
Desiree
Operator

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 Immunon'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 1 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 1 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 Immunon. Please go ahead.

speaker
Peter Vozzo
Investor Relations Representative, ICR Healthcare

Thank you, Desiree. Good morning, everyone, and welcome to Immunon'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 Immunon'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. Immunon 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. Stacey Lindborg, Immunon's President and Chief Executive Officer. Stacey?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Fowler, our Chief Medical Officer, and Mr. Jeff Church, our Interim Chief Financial Officer, who likely needs no introduction, given his tenure with Immunon. He'll be walking through and reviewing our financial results for the fourth quarter and full year of 2025. Mr. Michael Tardigno, 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, Immunon-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. And Immuno-001 is rapidly advancing in the Ovation 3 Pivotal Phase 3 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, Immuno01 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 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 Immune 101 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 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 Evasion II 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, and the investment community and leading clinicians heard directly from key opinion leaders about Immunon'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 2 study, Ovation 3 is a one-to-one randomized trial to evaluate iminon-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 results conference call underscore the strength of our phase two foundation, and the accelerating progress in phase three, based on the strong response from patients, our clinical trial investigators, and the broader medical community. And I'll just highlight a few areas, starting with site activation status. Phase three trial enrollment remained strong with seven clinical sites actively enrolling patients, and up to 43 additional high-quality centers under evaluation or in startup 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 three 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 three 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 one patient per month. This early momentum driven by the compelling Phase 2 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 3 trial combined, With a 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.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

and Europe.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

On translational data and the MRD trial data, we have data from the ongoing Phase 2 Minimal Residual Disease, or MRD, study collaboration with Breakthrough Cancer Foundation. This trial further reinforces Immunon's 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 3 Ovation 3 trial. Preliminary data from the Phase 2 MRD study continue to align with the overall survival benefits shown in the Phase 2 Ovation 2 study and support potential label extensions in the future. I'll now turn over the call to Dr. Douglas Fowler for clinical commentary. Douglas.

speaker
Dr. Douglas Fowler
Chief Medical Officer

Thank you, Stacey. The enthusiasm within the gynecologic community that we saw at our R&D day in November and throughout 2025 has only grown. The Phase 2 Ovation 2 clinical data showing a clinically meaningful 14.7-month median overall survival benefit and the ability of Immunon to activate both innate and adaptive immunity continue to resonate strongly with our investigators. Our multiple presentations at leading congresses in 2025 highlighted Immunon'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 three 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 Immunon 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 Immunon 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 Immunon-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, Stacey.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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 partnership discussions has allowed us to extend our cash runway while minimizing dilution and advance Immunon 001 as quickly as possible. Careholder equity remains paramount. Every decision is stress test 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 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 interest in potential non-dilutive partnerships for our TheraPlus technology platform and Immunon-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 cost 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 Immunon 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?

speaker
Jeff Church
Interim Chief Financial Officer

Thank you, Stacey. Details of Immunon'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 31st, 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 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-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 Stacey.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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

speaker
Desiree
Operator

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 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 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.

speaker
Desiree
Operator

Again, press star 1 to join the queue. And our first question comes from the line of Emily Bodnar with HC Wainwright.

speaker
Desiree
Operator

Your line is open.

speaker
Emily Bodnar
Analyst at HC Wainwright

Hi, Corrine. Thanks for the questions. 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 just kind of 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.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Thanks, Emily. That's a very well-formulated and comprehensive question. So let me take it in steps. So first, we have not presented the OS data to the FDA. You know, we are I'm incredibly excited by the fact that it continued to improve. But really, this last analysis reinforces exactly the plans that we have in place. I think you specifically asked about the PARP-treated patients. And, 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. So, 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 three 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. So maybe I'll stop there really quickly and see if there's anything else, Douglas, you want to add to the latest data.

speaker
Dr. Douglas Fowler
Chief Medical Officer

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. And 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. So the ability, as we replicate this in the phase three, This will be incredibly meaningful for patients, and 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 two, that's wonderful, but we're focused on providing benefit to the entire population of newly diagnosed women with advanced ovarian cancer.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Thank you. Emily, if I remember correctly, the other questions were focused around upcoming catalysts and our plan for this year and beyond. And, 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. And so you heard in my prepared remarks that we are – Our goal is to have 80 patients enrolled by this time next year. And reporting our momentum will be a very critical component of ultimately the overall timeline that we've been committed to. So that will be one catalyst. We will continue to have presentations at medical and scientific congresses. We have samples, tissue samples still for innovation too 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. And 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. And of course, we are continuing with our strategic goal of financing the trial with long-minded investors. And those are all things that we're very, very actively involved with. So 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. And then second, enrolling the trial and ensuring that we're spending a lot of time with our partners that are involved in this trial in the broader medical community as we're really helping translate the value for for women newly diagnosed and bringing forward a product that really should revolutionize the standard of care.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Perfect. Thank you.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Thank you, Emily.

speaker
Desiree
Operator

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

speaker
Desiree
Operator

Your line is open.

speaker
James Molloy
Analyst at Alliance Global Partners

Hey, guys. Thank you very much for taking my questions. Could you walk us through, you gave excellent guidance, 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?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Yeah, great question, James. Thank you. So the interim analyses which have been laid out are all very carefully designed through 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, so a p-value that would allow you to file your BLA. And as you know, we've described this in the past, and we've had reviews of our protocol. We've designed these for therapy, too. So the important component given what we know very well from the literature and other immunoagents. 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. So we've designed these interims to occur after the point that we would have fully enrolled trial. And we expect, based on the simulations that we've done in the past, that the first interim would occur about a year after that. So that is what we're actively working towards. And 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 may provide and 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. So that's kind of a bit of an insight into how we balance the various dimensions and what we can expect going forward.

speaker
James Molloy
Analyst at Alliance Global Partners

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

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

So, you know, it's obviously very early. We just released the data last week. We are participating tomorrow in the Med, MDOS, Biotech, and Pharma Investor Conference, and we are getting new inquiries that are occurring even as of this week. But 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. But we're very pleased to see renewed and new inquiries.

speaker
Camp Deliver
Analyst at Brookline Capital Markets

Thank you for taking the questions. Thank you.

speaker
Desiree
Operator

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

speaker
Desiree
Operator

Your line is open.

speaker
Jason McCarthy
Analyst at Maxim Group

Hey, Stacy. Thanks for taking the questions. Going back to Ovation 2, is there going to be an opportunity when you continue to mine that data, will you have anything related to minimal residual disease or any SLL 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?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

Yeah, maybe I'll start and then I'd like Douglas to pick up. So we won't have anything from Ovation 2 that relates to the minimal residual disease or second look laparoscopy 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. So that is an exploratory and it's an endpoint that I think has gotten a lot of interest as a potential predictor of overall survival that was incorporated into what we call the MRD study. So 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 trial that we're doing in combination with Breakthrough Cancer. But 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.

speaker
Dr. Douglas Fowler
Chief Medical Officer

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. So we're very excited about the translational data. Just to expand on what Stacey said, even though we call one of our trials MRD, 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 Breakthrough 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. And in addition, in our phase three, we will be looking at circulating tumor DNA. 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. So that's yet to come.

speaker
Jason McCarthy
Analyst at Maxim Group

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

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

It's possible. I think that it will ultimately depend really on... our interactions with the study PI, Dr. Amir Jazari, 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 patients over time, individual patients over time, and the clinical data, of course, will be continuing to evolve. So 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.

speaker
Jason McCarthy
Analyst at Maxim Group

I don't know, last question. I don't know if I'm overlapping with James that asked previously about enrollment timing, but when you get to the 80, are you going to release any details on the HRD status of the patient's so people can get a sense of the percentages that are in the trial or maybe in the trial?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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-commerce population has continued to grow so substantially that while the underlying genetics, which right now plays a critical role in the maintenance therapy and becomes 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. And so it will continue to be a very interesting and important part of our phase three trial. But 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 commerce population. So that's my thinking of this. And I think that we'll have to think very carefully about the exposure that we give to an ongoing phase three 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. But those will be taken with great caution just to preserve the integrity of the trial. Douglas, anything more?

speaker
Dr. Douglas Fowler
Chief Medical Officer

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. So we will not, even ourselves, be seeing the efficacy data as the trial progresses in terms of the primary endpoint.

speaker
Jason McCarthy
Analyst at Maxim Group

Okay, so just also, sorry, one more, just a hypothetical. I'm not sure if you'd have the answer for this or not. There is a trial that's going to read out in the second half of this year for an oncolytic virus in a relapsed or fractured setting for a 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. And I'm bringing it up because this trial is going to take a long time to 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.

speaker
Dr. Douglas Fowler
Chief Medical Officer

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 drugs. 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. And that's wonderful. We're very happy that there are drugs that provide a bit of a survival benefit in second or third line. But 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. So we're very happy to be in frontline, very proud of the fact that we're in frontline, and we believe that we will be providing advantage over time in terms of increases in survival to the patients that we're treating.

speaker
Camp Deliver
Analyst at Brookline Capital Markets

Got it. Thank you for taking all the questions.

speaker
Desiree
Operator

Thank you, Jason.

speaker
Camp Deliver
Analyst at Brookline Capital Markets

You're welcome.

speaker
Desiree
Operator

Next question comes from the line of Camp Deliver with Brookline Capital Markets.

speaker
Desiree
Operator

Your line is open.

speaker
Camp Deliver
Analyst at Brookline Capital Markets

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

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

So, 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 three. So, 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 the upcoming year and beyond. So 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 to ensure that we're bringing the most value possible and that we're really removing anything that is off

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

from the Ovation 3, which is our sole focus right now. Okay, thank you.

speaker
Camp Deliver
Analyst at Brookline Capital Markets

And with regard to your commentary regarding the pace of enrollment at the site level, I'm going to split a hair if I can because it may be informative. Is that pace increasing, say, month to month, or has it just been consistently increasing above your forecast?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

So I'll give you, 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. So if you look across all the sites, the average is above that. And 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. So 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. And I do think we're hearing phenomenal 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, 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 pure excitement with the data. Douglas, why don't you comment more?

speaker
Dr. Douglas Fowler
Chief Medical Officer

That'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.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

So we really think this would 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, was, you know, very clearly established in the literature. Phase 3 now, we have evidence of a clinical effect that's never been seen, and we continue to really hear that that becomes very critical. We can actually see the numbers that are entering pre-screening and we see a very 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 inability, perhaps somebody that's traveled a very long way and doesn't feel like they can make the the schedule, but really the rate of being exposed to this potential, the way that one of our PIs who's been involved with our program for a long time 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. So 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.

speaker
Camp Deliver
Analyst at Brookline Capital Markets

Great. Thank you.

speaker
Desiree
Operator

And our last question comes from the line of David Bouts with Wallcap Research.

speaker
Desiree
Operator

Your line is open.

speaker
David Bouts
Analyst at Wallcap Research

Hey, good morning, everyone. Thanks for the overview this morning. So I just have a couple of financial questions. So as resources become available, is the company going to look to open additional sites in the U.S., or will you be looking ex-U.S. to get any international sites open? And then as far as payments for the phase three trial, I guess I'm just trying to look at how was it being paid for? Did you have a bullet paid up front? Is it pay-as-you-go? How was it structured?

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

So, 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. So, we are actively enrolling and accelerating the enrollment of trials, and 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. So we've already had some discussions with leading sites in Central Europe. So that's a It's a conversation that we expect to advance over the next year. But 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 US. So we think that's actually the best way to start. In terms of payments for the trial, these trials are structured. This trial is structured pretty traditionally. You have contracts with individual sites. There are startup 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 Immunon. And we've taken full advantage of that to really structure structure the contracts accordingly.

speaker
Camp Deliver
Analyst at Brookline Capital Markets

Okay, great. Appreciate you taking the questions.

speaker
Desiree
Operator

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

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

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 two overall survival data and the compelling translational evidence that Douglas spoke about and our sharpened financial discipline, we really know that Immunon 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.

speaker
Dr. Stacey Lindborg
President and Chief Executive Officer

We thank you for your continued support and look forward to future calls.

speaker
Desiree
Operator

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

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