Imunon Q1 2026 Earnings Call - OVATION 3 Enrollment Gains Traction as Management Targets Non-Dilutive Financing

Tina, Conference Call Operator: 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 1 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 1 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.

Brandon Weiner, Investor Relations, ICR Healthcare: 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?

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: 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. Imunon 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-101 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-101 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-101 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?

Dr. Douglas Faller, Chief Medical Officer, Imunon: 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-101. I’m happy to say that investigators continue to proactively approach us about joining our phase III OVATION 3. 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-101. These consistent findings give us high confidence as we advance the pivotal phase III trial. Back to you, Stacy.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: 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-101, 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-101 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?

Jeffrey Church, Interim Chief Financial Officer, Imunon: 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 II study, supports our ability to advance the OVATION III 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 III study, and also in 2026, we’ve closed the OVATION II 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.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: Thank you, Jeff. Tina, that concludes our prepared remarks. If you could open the call for questions.

Tina, Conference Call Operator: Our first question comes from the line of Emily Bodnar with H.C. Wainwright & Co.. Please go ahead.

Emily Bodnar, Analyst, H.C. Wainwright & Co.: 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.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: Douglas, can you apprise us of our goals of fully enrolled?

Dr. Douglas Faller, Chief Medical Officer, Imunon: Sure

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: when we expect all the trial to be fully enrolled and other reflections on the interest in the trial?

Dr. Douglas Faller, Chief Medical Officer, Imunon: 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.

Emily Bodnar, Analyst, H.C. Wainwright & Co.: Great. Thank you.

Tina, Conference Call Operator: Your next question comes from the line of David Bautz with Zacks Small-Cap Research. Please go ahead.

David Bautz, Analyst, Zacks Small-Cap Research: 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?

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: 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?

Dr. Douglas Faller, Chief Medical Officer, Imunon: 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.

David Bautz, Analyst, Zacks Small-Cap Research: Okay. Great. Do you think this rate of enrollment has had any led to any increased collaborator interest at all?

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: Collaborator meaning partner, BD partner?

David Bautz, Analyst, Zacks Small-Cap Research: Yeah.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: 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.

David Bautz, Analyst, Zacks Small-Cap Research: Okay, great. Appreciate you taking the questions.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: Thanks, David.

Tina, Conference Call Operator: Your next question comes from the line of Jason McCarthy with Maxim Group. Please go ahead.

Jason McCarthy, Analyst, Maxim Group: 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?

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: 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 2 planned, right now they’re designed to allow for an early stopping for efficacy that would occur about 1 year or a year and a half after the fully enrolled patients. The second would occur about 1 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?

Dr. Douglas Faller, Chief Medical Officer, Imunon: 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.

Jason McCarthy, Analyst, Maxim Group: Great. Thank you both for your answers.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: Great. Thank you, Jason.

Tina, Conference Call Operator: 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.

Matt, Analyst, A.G.P.: 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.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: Matt, it’s a great question. Jeff, do you wanna cover just high level what we expect by quarter?

Jeffrey Church, Interim Chief Financial Officer, Imunon: 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.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: 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.

Matt, Analyst, A.G.P.: 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?

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: 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?

Dr. Douglas Faller, Chief Medical Officer, Imunon: 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.

Matt, Analyst, A.G.P.: Great. Thank you guys for taking our questions, and congrats again on Q.

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: Thanks, Matt.

Tina, Conference Call Operator: 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?

Dr. Stacy Lindborg, President and Chief Executive Officer, Imunon: 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.

Tina, Conference Call Operator: This concludes today’s conference call. You may now disconnect.