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Date

Tuesday, May 12, 2026 at 11 a.m. ET

Call participants

  • President and Chief Executive Officer — Stacy R. Lindborg, Ph.D.
  • Chief Medical Officer — Douglas V. Faller, M.D., Ph.D.
  • Interim Chief Financial Officer — Jeffrey W. Church
  • Executive Chairman, Board of Directors — Michael H. Tardugno

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Takeaways

  • Phase III OVATION III enrollment progress -- Enrollment is "on track" with 80 patients targeted by the end of 2027 out of a planned 500, and final enrollment projected in Q1 2029.
  • OVATION II Phase II clinical data -- IMNN-001 treatment plus standard of care produced a median overall survival benefit of 14.7 months.
  • Phase III primary endpoint -- Overall survival is the definitive efficacy endpoint, with planned interim analyses potentially allowing for early trial stops based on efficacy.
  • Enthusiasm from clinical sites -- Sites not previously participating in OVATION II have proactively requested inclusion in OVATION III, following publication of OVATION II data.
  • Ongoing operational discipline -- A strategic reorganization was completed in the first quarter, including eliminated and redefined roles to align with resource priorities.
  • Research and development expenses -- Increased to $2.3 million from $2.2 million in the prior-year period, reflecting OVATION III trial initiation and OVATION II completion.
  • General and administrative expenses -- Remained unchanged at $22 million for the quarter compared to the same period last year.
  • Net cash used in operations -- Reached $4 million, compared to $2.8 million in the prior-year quarter, mainly from trial-related costs associated with OVATION III start-up.
  • Future G&A projections -- Expected to increase to $4.5 million-$5 million per quarter as OVATION III ramps up with higher site activation and enrollment.
  • Pivotal study design and FDA engagement -- The ongoing trial is unblinded for patients and clinicians due to procedural ethics, and the FDA has provided written confirmation of no safety concerns at protocol finalization.
  • Financing strategies -- Plans include bridge financing designed to minimize shareholder dilution, possibly through preferred shares without warrants, no immediate tradability, and with at-market redemption.

Summary

Imunon (IMNN 1.10%) highlighted advancement of the IMNN-001 ovarian cancer program, underlined by a 14.7-month median survival benefit in Phase II and on-schedule Phase III enrollment targeting trial completion in Q1 2029. Management stated that ongoing cash conservation and a multipronged financing strategy are in place to sustain pivotal trial operations while aiming to limit dilution. Strong demand for trial participation—including unsolicited interest from new global sites—was reported following full publication of OVATION II data. The company emphasized its primary focus on overall survival as a regulatory endpoint, aligning with recent FDA guidance and positioning for potential full approval. Imunon confirmed clean and consistent safety data for IMNN-001 and plans to update investors at an R&D Day event with full OVATION II efficacy analysis later in 2026.

  • Douglas V. Faller said, "We expect the last patient to be enrolled in Q1 2029," clarifying the projected study timeline for full enrollment.
  • Stacy R. Lindborg stated that some clinical sites have demonstrated enrollment substantially above the assumptions in the protocol, citing heightened investigator engagement.
  • Interim analyses of the Phase III trial are planned, with the design enabling potential early stopping for efficacy a year to a year-and-a-half after full enrollment, as described by management.
  • The company did not signal pursuit of accelerated approval pathways, reiterating intent to achieve full approval based on overall survival endpoints in alignment with FDA requirements.

Industry glossary

  • Overall survival (OS): The length of time from randomization until death from any cause in a clinical trial, commonly viewed as the gold standard efficacy endpoint in oncology studies.
  • Bridge financing: Interim capital raised to fund operations or project milestones, typically structured to minimize dilution or provide flexibility ahead of larger financing events or trial readouts.
  • Preferred shares: Equity instruments that offer specific rights and privileges over common stock, often including dividend preference, liquidation priority, and—relevant here—potential redemption and restrictions on tradability.
  • Translational data: Results that link laboratory or mechanistic findings with clinical trial outcomes, used to demonstrate biological activity relevant to patient benefit.
  • Alpha spending: A statistical method of allocating the total type I error rate across multiple interim analyses in a clinical trial to control the likelihood of false-positive findings.

Full Conference Call Transcript

Stacy R. Lindborg: 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 Immuneon'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 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 R. Lindborg, Immunon's President and Chief Executive Officer. Stacy? Thank you, Brandon, and good morning to everyone joining us. On the call this morning. Joining me on the call is Doctor. Douglas V. Faller, our Chief Medical Officer, and Mr. Jeffrey W. Church, our Interim Chief Financial Officer. Who will review our financial results for 2026. Mr. Michael H.

Tardugno, the Executive Chairman of our Board, is also on the line and will be available for Q&A. We have entered 2026 with continued momentum following what was truly a transformative year in 2025 and we have made strong progress since our last conference call.

Douglas V. Faller: We recently announced the final clinical data from our completed Phase II study OVATION II of IMNN-001, our proprietary IL-12 immunotherapy continues to demonstrate its potential to redefine frontline treatment.

Stacy R. Lindborg: For women with newly diagnosed advanced ovarian cancer. The pivotal phase 3 study, OVATION III, is advancing well and we remain on track to randomize approximately 80 patients by the end 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 III 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 II Phase II clinical study. Has been very positive.

Focusing now on our phase 3 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 have seen in phase 2 and we expect to see in phase 3, our primary endpoint overall survival is both a major strength and a practical time consideration. On 1 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 are solving this dilemma in 2 ways. First, through a disciplined bridge financing strategy that raises targeted capital to advance OVATION III 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 immunon 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 dilutive and often include investors with little long term interest in the company. We will have more to say on this in the near future and we will provide updates as they become available. As always, our goal is to finance the company while not forgetting our shareholders and to keep a sharp focus on our North Star, which is bringing an innovative and much needed new treatment option to women with advanced ovarian cancer. Our approach has always intended to be as investor friendly as the options available to us permit.

Based on our unprecedented IMNN-001 clinical data thus far, we are confident that our program will attract investments from 1 or more strategic partners that is minimally dilutive or non dilutive. Looking ahead, we are planning an R&D Day event in 2026. And I look forward to inviting you to hear from our Immunon 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, the broader medical community supports our belief in the significant potential of immunon001 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 road malignancies. Something that we have the pleasure of experiencing on a regular basis. I will now turn over to Dr. Douglas V. Faller for clinical commentary.

Douglas V. Faller: Thank you, Stacy. Building on your comments, the enthusiasm within the gynecologic oncology community continues to grow. Our Phase II OVATION II 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 Immunon001's unique profile: localized IL-12 delivery with negligible systemic exposure, favorable safety, and clear signals of immune activation predictive of superior clinical outcomes. In addition, we look forward to presenting the final OS results from OVATION II 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 II, along with additional promising safety, efficacy, and translational data from our MRD study, and a new highly supportive translational data from OVATION II. 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 am happy to say that investigators continue to proactively approach us about joining our phase 3 OVATION study. As Stacy said, 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 2 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 3 trial. Back to you, Stacy.

Stacy R. 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 III study. Now over to Jeffrey W. Church for a review of our first quarter 2026 financial results.

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 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 2026, from $2.2 million in the same period last year. During 2025, the company initiated enrollment of the OVATION III study.

Also, in 2026, we have closed the OVATION II study. General and administrative expenses, remain unchanged at $22 million in each of the first quarters of 2026 and 2025. Net cash used for operating activities was $4 million in 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 III study. With that financial review, I will turn the call back to Stacy.

Stacy R. Lindborg: Thank you, Jeffrey. Tina, that concludes our prepared remarks. If you could open the call for questions at this time.

Operator: I would like to remind everyone if you would like to ask a question, press *1 on your telephone keypad. Again, that is *1 to ask a question. And our first question comes from the line of Emily Bodnar with H. C. Wainwright. Please go ahead.

Analyst (Emily Bodnar): Hi. Good morning. Thanks for taking the questions. I noticed you gave initial guidance on enrollment completion for the first time. So maybe just kind of walk us through what gives you confidence in this timing and how demand for OVATION III enrollment has kind of played into those assumptions?

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

Douglas V. Faller: Yep. I am happy to. Hi, Emily. Thanks for your question. We are enrolling 500 patients total, as you know, in our study. And we expect the last patient to be enrolled in Q1 29. We are increasing the number of sites that we have activated and that is 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 should be 16% of the total that we will enroll for the trial.

Stacy R. Lindborg: Great.

Operator: Thank you. Your next question comes from the line of David Bouth with Zacks Small Cap Research. Please go ahead.

Analyst (David Bautz): Hey. Good morning, everyone. Thanks for the update today. So, another question about enrollment. So you have been indicating, for a while now that enrollment has been, I guess, remaining ahead of schedule. Was I was wondering if you could just quantify that a little bit. Is this due to, you know, site efficiency investigator enthusiasm, patient demand?

Stacy R. Lindborg: what is kind of driving that? Yeah, maybe I will start and, Douglas, you add. You know, trials always have an assumption of patients per site per month. And when we look at early in a trial, when you are starting with your early sites, always have internal targets by month that we are hoping to accomplish. And when we say we are ahead of target, it really reflects that by month we have 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 are 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 2029. That then becomes our true target, and it becomes critical that we are enrolling sites up to the number that we believe we need to be successful in doing so. And I would say we are tracking very well with the process of now a brand-new cohort of sites that are coming on board. I am really delighted by the early sites. These are obviously strong partners from Ovation 2, they know our product.

They comment when we are with them in their centers of how visible it is to them when they are doing surgery on their patients, how different women who have been treated with IMNN-001 look relative to the control. And therefore it is not surprising that some of these are substantially above the assumptions that we have made for the number of patients you know, per site across the whole study, but it is been quite remarkable, you know, from that viewpoint. But Douglas, why do not you offer some additional perspective?

Douglas V. Faller: Well, I will echo what Stacy said and also just mention that we have been very gratified at the excitement and the number of patients, some of the sites have enrolled upon just starting up. it is 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. 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.

Stacy R. Lindborg: Okay. Great.

Analyst (David Bautz): And do you think this rate of enrollment has had any, like, any increased collaborator interest? at all?

Stacy R. Lindborg: Collaborative, meaning partner, BD partner? Yeah. I do not think that is necessarily, interacting in terms of those 2 streams, but I do think that the opposite would be true if we are not successfully enrolling the trial, then you can expect that would have a negative impact on BD and I would say even investor interactions.

But I think that this really ultimately being able to describe which Douglas has spoken of in the past, I think could elaborate on if you would like, but, you know, we continue to have sites that were not part of OVATION II that reach out, that are seeing our data presented in the scientific community when the paper came out with the full publication from OVATION II, We had outreach from centers, not just in The US, but in other parts of the world.

And that enthusiasm tied with the other aspect of the visibility that we have 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, etcetera.

Analyst (David Bautz): Okay. Great. Appreciate you taking the questions.

Stacy R. Lindborg: Thanks, David.

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

Analyst (Jason McCarthy): Hi, Stacy. Thanks for taking the questions. Could you just more of an abstract question. Could you just review with us-- sorry. Review with us the powering assumptions around OVATION III and how many months OS you would need to see And I know it is far off, but that interim data sometime in, call it, 20, 30 or so is that expected to be blinded or unblinded in terms of sacrificing some of the power and more broadly, there is been an uptick in clinical trial activity around PD-1 inhibitors. there is new ADCs. That have come after in HER 2. there is 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 III trial potentially having an impact? Positive or negative.

Stacy R. Lindborg: So those are great questions. Jason. Let me try to take them 1 at a time, and I think that, I will start with the first 2. Number 1, it is an unblinded trial in the sense of that 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 that is separate from saying, is there structure and appropriate protection of the trial and integrity of the data that is occurring in the trial. And so there are components of what we do that really we will be operating in a manner in terms of access to data unless it is truly needed for the job and would fit best practices, we will be acting in a manner as if it is blinded internally.

And in terms of the assumptions, you know, we have continued to see the treatment effect grow across the number of times that we refreshed the OVATION II data, and then finally, of course, the final readout as we prepared and now have closed out the trial. So we saw the trial go from initially an 11-month benefit over the standard of care in overall survival, median overall survival upwards to close to 15 months, which is really quite remarkable. And, you know, you will hear more from us in the future.

We are really looking at how we can harness the final data set and how we can bring that to bear in terms of the phase 3 trial and if, in fact, it would permit us to pull forward the final analysis. So I would say it is early for us to talk about that, but it is something that we are 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. So the trial that we have described in the past in this will continue, will have interim analyses.

We have 2 planned, and right now they are designed to allow for an early stopping for efficacy that would occur about a year or a year and a half after the patients are fully enrolled. The second would occur about a year later, and I think that we will be offering more guidance on this front.

So in the last piece is that in terms of the blinded and unblinded aspect as we are ultimately talking to investors and thinking about how we can align a financing with long-term 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 1 of the exciting aspects of the fact that it is an unblinded trial, it will, you know, permit us to allow for consideration of gaining and giving insight publicly into the secondary endpoint.

So to really build some confidence that we are observing what we are observing in secondary endpoints, which are all hard endpoints pathological scoring, and other such endpoints that were part of our OVATION II and really building a confidence that could de risk financings and tranches, especially over time. So those are things that we are 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 would be happy to, Jason. So as a clinician, I am very excited that there are second line plus therapies being developed, including the ADCs you mentioned. And also actually bare antibodies. The community is excited by this because we have been so limited in what we could provide patients, second and third line and fourth line. While these are advances, I think 1 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 are talking months and they are 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 are 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 inhibitor, some of them, have led to the FDA walking back some of the approvals. This does not affect our study. We are using PARP inhibitors as the FDA has suggested.

But it just to me, further highlights the need for new and effective treatments up front. Which is what we are 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 II, which are not a few months benefit in survival, but over a year in survival. that is our ambition.

Stacy R. Lindborg: Great. Thank you both for your answers.

Analyst (Jason McCarthy): Great. Thank you, Jason.

Operator: And our next question comes from the line of James Molloy with AGP. Please go ahead.

Analyst (Matt): Hi, guys. This is Matt on for James Molloy today. Thank you guys for taking our 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? And then I have a follow-up on clinical.

Stacy R. Lindborg: Matt, it is a great question. And, Jeffrey, do you wanna-- do you wanna cover just high level what we expect by quarter?

Jeffrey W. Church: Right. Based upon our current projections after the reorganization that occurred that we implemented in the first quarter, we are looking at spends over the next, you know, coming quarters in the 4.5 to 5 million. We expect that 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.

Stacy R. Lindborg: And, Matt, just to follow-up on a point to what Jeffrey 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, do not 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 are all focused on the launch of the Phase III trial directly towards the completion and preparation for the commercial landscape, both in the manufacturing side and as we begin to prepare for the BLA.

Analyst (Matt): Great. Thanks for that. And 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 CBER 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 R. Lindborg: Yes. I think that, you know, we have designed a really well thought out trial, which has always received very positive and professional engagement with the FDA. So we have described over time, but I never get tired of reflecting on the point that we got it in writing from the 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 2 meeting. So, you know, we clearly understand that we have designed a trial that sets us up for filing if we are successful, if the trial meets the statistical thresholds.

And it is also under the agreement with the FDA interim analyses are a core part of the trial design and the analysis plan. They are designed to allow for full approval of the group that is being analyzed in that interim analysis if we meet the threshold. So as with all phase 3 trials, clearly outline what that threshold will be.

We have used a very efficient alpha spending for the interim analyses, but that probably goes beyond what you are wanting to talk about, but that is something we care a lot about is being very efficient and ensuring that we are giving enough of an opportunity to the interims but then ultimately allowing the final analysis to really be set up very effectively. So we are really not right now with this phase 3 trial focused on the idea of accelerated approval. We are focused on full approval.

But I do think we will keep a 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 are speaking about. Douglas, do you have anything you want to add to that?

Douglas V. Faller: I just wanted to add 1 thing. As you know, Matt, accelerated approvals are usually based on early surrogate endpoints. And the upheaval at the FDA and some of the decisions that they have made really do not 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 is 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 and all my years of experience, an OS benefit is never questioned.

So we are not we are not having to deal with we will not have to deal with potential changes in what is expected by the FDA. We have the gold standard and what they call the gold standard as our primary endpoint.

Analyst (Matt): Great. Thank you guys for taking our questions. And congrats again on the queue.

Stacy R. Lindborg: Thanks, Matt.

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

Stacy R. Lindborg: Thank you all for joining the call. With our Phase III trial OVATION III patient enrollment on track, the enduring strength of our Phase 2 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.