Imunon, Inc. (NASDAQ:IMNN) Q1 2026 Earnings Call Transcript

Imunon, Inc. (NASDAQ:IMNN) Q1 2026 Earnings Call Transcript May 12, 2026

Imunon, Inc. beats earnings expectations. Reported EPS is $-0.84, expectations were $-1.215.

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. [Operator Instructions] I would now like to turn the call over to Brandon Weiner of ICR Healthcare Investor Relations, representative of IMUNON. Please go ahead.

Brandon Weiner: 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, and actual results may differ materially from such statements.

I also caution that the content of this conference call is accurately 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?

Stacy Lindborg: Thank you, Brandon, and 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, and 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, and IMNN-001, our proprietary IL-12 immunotherapy continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer.

The pivotal Phase III study, OVATION 3, is advancing well, and 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 2 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 provide — we will provide updates as they become available. As always, our goal is to finance the company while not forgetting our shareholders and to keep a sharp focus on our North Star, which is bringing an innovative and much needed new treatment option to women with advanced ovarian cancer.

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

I’ll now turn it over to Dr. Douglas Faller for clinical commentary. Douglas?

Douglas V. Faller: 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 a new highly supportive translational data from OVATION 2. Building on the transformative clinical and translational results we have already reported in the public domain, these presentations will further highlight the significant potential of IMNN-001. I’m happy to say that investigators continue to proactively approach us about joining our Phase III OVATION study. Study enrollment is progressing nicely and remains on track with current sites performing well. Safety data remains clean and consistent with prior clinical results, including data from the ongoing Phase II MRD study, which further support the favorable tolerability and unique mechanism of action of IMNN-001.

These consistent findings give us high confidence as we advance the pivotal Phase III trial. Back to you, Stacy.

Stacy Lindborg: Thank you, Douglas. Before turning to our financial update, I want to highlight that we remain focused on disciplined execution and strategic focus as we advance the most important development program in our company’s history, IMNN-001, and of course, with our initial sites on ovarian cancer. Our multipronged financing strategy continues to balance the need to extend our cash runway while minimizing dilution and moving IMNN-001 forward as quickly as possible. Shareholder value remains paramount and every decision is stress test 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 W. Church: Thank you, Stacy. Details of IMUNON’s first quarter 2026 financial results are included in the press release we issued this morning and in our Form 10-Q, which we filed before the market opened this morning. We continue to manage our cash position prudently through targeted financing activities, cost-saving initiatives and operational efficiencies. Our disciplined approach, including the strategic reorganization announced earlier this year and the completion of the OVATION 2 study supports our ability to advance the OVATION 3 study while extending our operating runway. Research and development expenses increased to $2.3 million in the first quarter of 2026. from $2.2 million in the same period last year. During 2025, the company initiated enrollment of the OVATION 3 study.

And also in 2026, we’ve closed the OVATION 2 study. General and administrative expenses remain unchanged at $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 associated with starting up the OVATION 3 study. With that financial review, I’ll turn the call back to Stacy.

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

Q&A Session

Operator: [Operator Instructions] And our first question comes from the line of Emily Bodnar with H.C. Wainwright.

Emily Bodnar: I noticed you gave initial guidance on enrollment completion for the first time. So 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?

Stacy Lindborg: Douglas, can you apprise us of our goals of fully enrolled? When we expect all the trial to be fully enrolled and other reflections on the interest in the trial?

Douglas V. Faller: I’m happy to. 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. And we are expecting to have 80 patients enrolled approximately a year from now, as I think you know, which would be [indiscernible] of the total that we will enroll for the trial.

Operator: Your next question comes from the line of David Bautz with Zacks Small-Cap Research.

David Bautz: So another question about enrollment. So 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 site efficiencies or investigator enthusiasm, patient demand? What’s kind of driving that?

Stacy Lindborg: Yes. Maybe I’ll start, and Douglas, you can add. Trials always have an assumption of patients per site per month. And when we look at early in the trial, when you are starting with your early sites, we always have internal targets for — by month, right, that we’re hoping to accomplish. And 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 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.

And 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. And I’m really delighted by the early sites. These are obviously — we’re 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. And therefore, it’s not surprising that some of these are substantially above the assumptions that we’ve made for the number of patients per site across the whole study. But it’s been quite remarkable from that viewpoint. But Douglas, why don’t you offer some additional perspective?

Douglas V. Faller: 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, 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. So, 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: Okay. Great. And do you think this rate of enrollment has had any — led to any increased collaborator interest at all?

Stacy Lindborg: Collaborator, meaning partners, BD partners?

David Bautz: Yes.

Stacy Lindborg: I don’t think that’s necessarily interacting in terms of those 2 streams. But 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 impact on BD and I’d say even investor interactions. But I think that this really ultimately being able to describe which of us have spoken of in the past, I think could elaborate on if you’d like. But 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 full publication from OVATION 2. We had outreach from centers, not just in the U.S. but in other parts of the world. And that enthusiasm tied with 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 all of our endeavors, partnerships, investors, et cetera.

Operator: Your next question comes from the line of Jason McCarthy with Maxim Group.

Jason Mccarthy: Could you — it’s more of an abstract question. Can you just review us — sorry, review with us the powering assumptions around OVATION 3 and how many months OS you need to see? And 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? And more broadly, there’s been an uptick in clinical trial activity around WEE1 inhibitors. There’s new ADCs that have come after Enhertu. There’s been a lot of activity around the PI3Ks in different categories. So 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?

Stacy Lindborg: So these are great questions, Jason. Let me try to take them one at a time. And I think that I’ll start with the first 2. Number one, it’s an unblinded trial in the sense of 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. So we — that’s separate from saying, is there a structure and appropriate protection of the trial and integrity of the data that’s occurring in the trial. And so there are components of what we do that will really — we will be operating in a manner in terms of 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 blinded internally. And in terms of the assumptions, we have continued to see the treatment effect grow across the number of times that we refreshed the OVATION 2 data. And then finally, of course, the final readout as we prepared and now have closed out the trial site. So we saw the trial go from initially an 11-month improvement over the standard of care and overall survival, median overall survival upwards to close to 15 months, which is really, really quite remarkable. And 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.

So 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 you’re your trial is really operating in the best information possible. So the trial that we have described in the past, and this will continue, we’ll have interim analyses. We have 2 planned. And right now, they’re designed to allow for an early stopping for efficacy that would occur about a year or 1.5 years after the fully enrolled patients. The second would occur about a year later. And I think that we’ll be offering more guidance on this front. So — and 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 the 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.

And 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. So to really build some confidence that we’re observing, 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 derisk financings and tranches, especially over time. So 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?

Douglas V. Faller: I’d be happy to, Jason. So as a clinician, I’m very excited that there are second-line plus therapies being developed, including the ADCs you mentioned and also actually Ber antibodies. The community is 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. Yet they are going to be available for our patients, second and third line, both the treatment arm and the control arm. And so 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. But it just, to me, further highlights the need for new and effective treatments upfront, which is what we’re delivering. So the landscape for patients, second and third line has improved somewhat, maintenance, perhaps less so. But we are in front of all of these things, and we are expecting — 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.

Operator: [Operator Instructions] And our next question comes from the line of James Molloy with AGP.

Matthew Venezia: Matt on for Jim today. 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? And I have a follow-up on clinical.

Stacy Lindborg: Matt, it’s a great question. And Jeff, do you want to cover just high level what we expect by quarter?

Jeffrey W. Church: Right. Based on our current projections after the reorganization that we implemented in the first quarter, we’re looking at spend over the next coming quarters in the $4.5 million to $5 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 3 study.

Stacy Lindborg: And Matt, just a follow-up point to what Jeff just provided, what we shared in terms of the strategic restructuring, there were positions eliminated, but there also were jobs that were redefined. And so 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 the 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.

Matthew Venezia: Great. And then in terms of just the kind of reorganization broadly at the FDA, have there been any discussions about utilizing some of these pathways like CNPD later down the line, accelerated approval as you guys get to the interim reads? And how have those gone with this new kind of administration there?

Stacy Lindborg: Yes. I think that we’ve designed a really well-thought-out trial, which has always received very positive and professional engagement with the FDA. So we’ve described over time, but it’s — I never get tired of reflecting on 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 in the end of Phase II meeting. So 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. And 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 interim analysis if we meet the threshold.

So as with all Phase III trials, you clearly outlined what that threshold will be. We’ve used a very efficient alpha spending for the interim analysis. 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 getting enough an opportunity to the interims, but then ultimately allowing the final analysis to really be set up very effectively. And so we’re really not right now with this Phase III trial focused on the idea of accelerated approval. We’re focused on full approval. But I do think we’ll keep line of sight to ways and opportunities that maybe will allow 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 want to add to that?

Douglas V. Faller: I just wanted to add one thing. As you know, Matt, accelerated approvals are usually based on early surrogate endpoints. And the upheaval of 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 in oncology in all my years of experience, an OS benefit is never questioned. So we’re not having to deal with — 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.

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?

Stacy Lindborg: 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 value inflecting milestones in 2026 and beyond. I want to 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 continued support.

Operator: And this concludes today’s conference call. You may now disconnect.