Imunon (NASDAQ:IMNN) released first-quarter financial results and hosted an earnings call on Tuesday. Read the complete transcript below.
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Summary
Imunon reported an increase in R&D expenses to $2.3 million in Q1 2026, up from $2.2 million in the same period last year, primarily due to trial-related expenses for the Ovation 3 study.
The company is focusing on its pivotal Phase 3 study, Ovation 3, with plans to enroll approximately 80 patients by the end of Q1 2027 and fully enroll 500 patients by Q1 2029.
Imunon is employing a disciplined bridge financing strategy to support Ovation 3, aiming to minimize dilution and maintain shareholder value.
The company plans to hold an R&D day event in Q3 2026 to showcase clinical data and insights from its Immunon 001 program.
Management highlighted the positive reception from the investment community to their progress, as well as a strong response from trial investigators and the broader medical community.
Imunon aims to maintain financial discipline through cost-saving initiatives and operational efficiencies to extend its cash runway and support ongoing trials.
Full Transcript
Tina (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 one 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 star one to ask your question during the Q and A session. I would now like to turn the call over to Brandon Weiner of ICR Health Care Investor Relations Representatives of Imunon. Please go ahead.
Brandon Weiner (ICR Health Care Investor Relations Representative)
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 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. Stacey Lemberg, Imunon's President and Chief Executive Officer.
Stacy
Stacy thank you Brandon, and good morning to everyone joining us on the call this morning. Joining me on the call is Dr. Douglas Fowler, 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 and 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 2 study, Ovation 2 and Imunon 001. Our proprietary IL12 immunotherapy continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer the pivotal phase three 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 2 clinical study, has been very positive. Focusing now on our Phase three 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 two and we expect to see in Phase three, 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 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 immunon 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 non dilutive. Looking ahead, we are planning an R and 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 ImmunoN001 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 Imunon 001 to make a meaningful difference 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 Foller for clinical commentary. Douglas
Douglas Fowler
thank you Stacy. Building on your comments, the enthusiasm within the gynecologic oncology community continues to grow. Our Phase 2 Ovation 2 clinical data showing a clinically meaningful 14.7 month median overall survival benefit with Imunon 001 treatment plus standard of care, chemotherapy and the ability of Imunon 001 to activate both innate and adaptive immunity remains highly compelling to investigators. Our scientific presentations have reinforced Imunon 001's unique profile, localized IL12 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 and 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 Imunon 001. I'm happy to say that investigators continue to proactively approach us about joining our Phase three 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 2 MRD study, which further support the favorable tolerability and unique mechanism of action for of Imunon 001. These consistent findings give us high confidence as we advance the pivotal Phase three trial. Back to you, Stacey thank you, Douglas.
Stacy
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, Imunon 001 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 Imunon 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.
Jeffrey Church
Jeff? 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 10Q, 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 closed the Ovation 2 study. General administrative expenses remained 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 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.
Tina (Operator)
Thank you, Jeff. Tina, that concludes our prepared remarks. If you could open the call for questions at this time, I would like to remind everyone, if you would like to ask a question, press Star one on your telephone keypad. Again, that is Star one to ask a question. And our first question comes from the line of Emily Bodnar with HC Wainwright. Please go ahead.
Emily Bodnar (Equity Analyst)
Hi, good morning. Thanks for your questions. 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. 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 Fowler
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. And we are expecting to have 80 patients enrolled approximately a year from now, as I think you know, which should be of the total that we will enroll for the trial. Great, thank you.
Tina (Operator)
Your next question comes from the line of David Bolts with Zach Smallcap Research. Please go ahead.
David Bolts (Equity Analyst)
Hey, good morning, everyone. Thanks for the update today. So another question about enrollment.
Douglas Fowler
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 efficiency? Is it investigator enthusiasm, patient demand? What's kind of driving that? Yeah, maybe I'll start. And Douglas, you can add, trials always have a assumption of patients per site per month. And when we look at early in a trial, when you are starting with your early sites, we always have internal targets 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 know, 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, you know, 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 immune 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? 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 Immunon 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 Bolts (Equity Analyst)
Okay, great. And do you think this rate of enrollment has led to any increased collaborator interest at all? Collaborative, meaning partner, BD partner?
Stacy
Yeah, I don't think that's necessarily interacting in terms of those two streams, but I do think that the counter would be true. If we are not successfully enrolling, 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 Douglas has spoken of in the past and 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, you know, the full publication from Ovation 2, we had outreach from centers not just in the US but in other parts of the world. And 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 impacted all of our endeavors, partnerships, investors, et cetera. Okay, great. Appreciate you taking questions.
Tina (Operator)
David, your next question comes from the line of Jason McCarthy with Maxim Group. Please go ahead.
Jason McCarthy (Equity Analyst)
Hi, Stacy, thanks for taking the questions.
Stacy
Could you. It's more of a abstract question. Could you just review us? Sorry. Review with us the powering assumptions around Ovation 3 and how many months OS you'd need to see. And I know it's 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'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. 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?
Douglas Fowler
So 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 two. Number one, it's 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, 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 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 will 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, 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 three 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 your, your trial is really operating in the best information possible. So the trial that we have described in the past and this will continue will have interim analyses. We have two planned and right now they're designed to allow for an early stopping for efficacy that would occur about a year or a year and a half 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. The last piece 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. 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 de risk 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?
Jason McCarthy (Equity Analyst)
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 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. 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 inhibitor, 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 up front, 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. Great. Thank you both for your answers.
Stacy
Great. Thank you, Jason.
Tina (Operator)
As a reminder to ask a question, simply press Star one and our Next question comes from the line of James Molly with agp. Please go ahead.
Matt
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 SGA spend to look going forward given the recent reorganization? Then I have a follow up on clinical
Jeffrey Church
Matt. It's a great question, Jeff. Do you want to cover just high level what we expect by quarter? Right. Based upon our current projections after the reorganization that we occur that we implemented in the first quarter, we're looking at spends over the over the next coming quarters. In the 4.5 to 5 million. We expect our GNA 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 start starts to step up as it relates to the Ovation 3 study.
Stacy
And Matt, just a 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. 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 three trial directly towards the completion and preparation for the commercial landscape, both in the manufacturing and as we begin to prepare for the bla.
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 utilizing some of these pathways like CNPV 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
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 and the end of phase two meeting. So we clearly understand that we've designed a trial that sets us up for filing if we're successful, if the trial is 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 three 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. And so we're really not right now with this phase three 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 Fowler
I just wanted to add one 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'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.
Douglas Fowler
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. 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.
Matt
Great. Thank you guys for taking our questions. And congrats again on Q.
Stacy
This concludes the Q and a portion of the call. I'll now turn the call back to Immunon's president and CEO for concluding remarks. Stacy,
Tina (Operator)
thank you all for joining the call. With our Phase 3 trial, Ovation 3, patient enrollment on track, the enduring strength of our phase 2 overall survival data and the compelling translational evidence, and our sharpened financial discipline. Immunon is well positioned for value inflecting milestones in 20, 26 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.
Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.
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