Imunon, Inc.(IMNN)Q1 2026 法說會逐字稿

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 speakers' remarks, there will be a question-and-answer session. You may press *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 *1 to ask your question. During the Q&A session, I would now like to turn the call over to Peter Vozzo of ICR Health Care investor relations. Representatives of Imunon, please go ahead.

Representatives of Imunon, please go ahead.

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. Stacy R. Lindborg, Imunon'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 Dr. 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.

We recently announced the final clinical data from our completed Phase II study OVATION II. 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 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 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 are solving this dilemma in two 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 Imunon 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 one or more strategic partners that are 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 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 solid 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.

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 IMNN-001'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 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.

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-tested 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.

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 $2.2 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.

Thank you, Jeffrey. 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 *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.

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

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?

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 2029. We are increasing the number of sites that we have activated and that has been a push this year. We are expecting to have 80 patients enrolled approximately a year from now, which should be about 16% of the total that we will enroll for the trial.

Great.

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

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. I was wondering if you could just quantify that a little bit. Is this due to site efficiency, investigator enthusiasm, patient demand?

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. Early in a trial, when you are starting with your early sites, we always have internal targets by month that we are hoping to accomplish. When we say we are ahead of target, it really reflects that by month we have consistently had more patients enrolled than we were forecasting. As we ultimately set goals, 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. 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 II; they know our product. They comment when we are with them in their centers on 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. Therefore, it is not surprising that some of these are substantially above the assumptions that we have made for the number of patients per site across the whole study. It has been quite remarkable from that viewpoint. Douglas, why don't you offer some additional perspective?

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 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, our whole clinical team has been very happy with the strong engagement of the investigators. In some cases, a flurry of activity occurs as soon as their site is activated.

Okay. Great.

And do you think this rate of enrollment has had any increased collaborator interest at all?

Collaborative, meaning a business development partner? I do not think those two streams are necessarily interacting directly, but the opposite would be true: if we were not successfully enrolling the trial, that would have a negative impact on business development and investor interactions. We continue to have sites that were not part of OVATION II reach out after 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 U.S. but in other parts of the world. That enthusiasm, tied with the visibility we have gotten in the medical community, really speaks volumes, and I do think all of those positively impact our endeavors — partnerships, investors, etc.

Okay. Great. Appreciate you taking the questions.

Thanks, David.

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

Hi, Stacy. Thanks for taking the questions. Could you just — more of an abstract question — review with us the powering assumptions around OVATION III and how many months OS you would need to see? I know it is far off, but that interim data sometime in, call it, 2029 or so — is that expected to be blinded or unblinded in terms of sacrificing some of the power? And more broadly, there has been an uptick in clinical trial activity around PD-1 inhibitors, new ADCs, activity around PI3Ks in different categories. How do you see the treatment landscape potentially shifting in ovarian cancer over the duration of the OVATION III trial and potentially having an impact — positive or negative?

Those are great questions, Jason. Let me try to take them one at a time, and I will start with the first two. Number one, the trial is unblinded in the sense 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. That is separate from saying whether the study has structure and appropriate protection of the trial and integrity of the data. We will be operating in a manner internally as if it is blinded with appropriate protections for data access unless it is truly needed for the job and consistent with best practices. In terms of the assumptions, 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. We saw the trial go from initially an 11-month benefit in median overall survival over standard of care upwards to close to 15 months, which is quite remarkable. We are looking at how we can harness the final dataset and how we can bring that to bear in terms of the Phase 3 trial and whether it would permit us to pull forward the final analysis. It is early to talk about that, but it is something we are carefully thinking through. As any company would, when you have new information you want to make sure your trial is operating with the best information possible. The trial we have described will continue and will have interim analyses. We have two planned, and right now they are designed to allow for early stopping for efficacy that would occur about a year to a year and a half after the patients are fully enrolled. The second would occur about a year later, and we will be offering more guidance on this front. The unblinded nature of the trial will permit us to consider gaining and giving insight publicly into secondary endpoints to build confidence that we are observing meaningful effects on secondary endpoints — these are hard endpoints such as pathological scoring and other translational measures that were part of OVATION II — which could de-risk financings and tranches over time. Those are things we are working through and they have resonated well with our discussions with investors. On the front of changes in the competitive landscape, Douglas, can you offer some perspective?

I would be happy to, Jason. As a clinician, I am very excited that there are second-line and later therapies being developed, including the ADCs and some antibodies. The community is excited because we have been so limited in options for second, third, and fourth line. While these are advances, they are relatively modest: the benefits in terms of PFS and survival are generally small — we are talking months — and they are not curative. They will be available for patients second and third line, both in treatment arms and control arms, so the implications on our study are modest, I think. Furthermore, just to emphasize the importance of frontline care, which is what we are delivering: even PARP inhibitors, which as maintenance have improved PFS in frontline ovarian cancer, are being viewed more restrictively now. The actual benefit of some PARP inhibitors has led to regulatory reassessments. This does not affect our study — we are using PARP inhibitors as the FDA has suggested — but it further highlights the need for new and effective treatments up front, which is what we are delivering. We hope to reproduce the results we saw in OVATION II, which are not merely a few months' benefit but over a year in survival. That is our ambition.

Great. Thank you both for your answers.

Great. Thank you, Stacy and Douglas.

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

Hi, guys. This is Matt on for James Molloy today. Thank you guys for taking our questions and congrats on the progress this quarter. Just a few from us. How should we expect SG&A spend to look going forward given the recent reorganization? And then I have a follow-up on clinical.

Matt, it is a great question. Jeffrey, do you want to cover just high level what we expect by quarter?

Right. Based upon our current projections after the reorganization that we implemented in the first quarter, we are looking at spend over the coming quarters in the $4.5 to $5.0 million range per quarter. We expect that our G&A level will 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.

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. A huge part of this is ensuring that our resources are being well allocated. We clearly do not want to carry resources that are not directly contributing to our top priorities, but it is also about making sure we can go as quickly as possible and that we are all focused on the launch of the Phase III trial and directly towards completion and preparation for the commercial landscape, both in the manufacturing side and as we begin to prepare for the BLA.

Great. Thanks for that. And then in terms of the reorganization broadly and engagement with the FDA, have there been any discussions about utilizing pathways like accelerated approval or other avenues later down the line as you get to the interim reads, and how have those gone with the current administration at the FDA?

Yes. We have designed a well-thought-out trial which has received positive and professional engagement with the FDA. We obtained written feedback from the FDA that they had no safety concerns about the trial around the time we finalized the protocol and the end-of-phase 2 meeting. We clearly understand that we have designed a trial that sets us up for filing if we are successful and if the trial meets the statistical thresholds. Interim analyses are a core part of the trial design and analysis plan; they are designed to allow for full approval of the group analyzed in that interim analysis if we meet the threshold. As with all Phase 3 trials, thresholds are clearly outlined. We have used an efficient alpha-spending approach for the interim analyses. Right now, with this Phase 3 trial, we are focused on full approval, but we will keep a line of sight to ways and opportunities that may allow additional interactions with the FDA or higher-priority engagement. If we reach a point where we want to formally engage the FDA about accelerated pathways, we will consider that.

I just wanted to add one thing, Matt. Accelerated approvals are usually based on early surrogate endpoints, and the recent focus and decisions at the FDA do not affect us. We are looking at overall survival, and the FDA recently reiterated that OS is the preferred primary endpoint for oncology trials. That has always been our intention and how our trial is written. In my experience, an OS benefit is rarely questioned by the FDA. We have the gold standard as our primary endpoint.

Great. Thank you guys for taking our questions. And congrats again on the progress.

Thanks, Matt.

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?

Thank you all for joining the call. With our Phase III trial OVATION III patient enrollment on track, the enduring strength of our Phase II overall survival data, 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.

And this concludes today's conference call. You may now disconnect.