Imunon, Inc. Common StockIMNN
Recorded

Imunon, Inc. Common Stock R&D Day 2026

Review the key takeaways and the transcript of this earnings call.

Period 2026Duration2 hr 18 minParticipants11

Transcript

Preview the first fifteen paragraphs, organized by speaker.

Stacy LindborgPresident and CEO

Good morning, everybody. I'm Stacy Lindborg, President and CEO of Imunon, and I'm very grateful to welcome you to the 2026 R&D Day. It's great to see a full room here, and we have a really strong registration and online participation. We're excited by what we're going to share with you and the opportunity to spend real time thinking about frontline ovarian care treatment. We've got a wonderful set of speakers, very experienced and with unique perspective that I know they will impart to you. We, this morning, will be focusing a lot on the data that we've accumulated. We have a phase II trial that's completed with overall survival data, which is critical. Our product is built around IL-12, a cytokine that was tried by the industry for more than 2 decades and then was largely abandoned.

Stacy LindborgPresident and CEO

By the end of this session, my hope is that you will leave with 3 things. Number one, an insight into why IL-12 historically failed. Number two, why IMNN-001 is different, and number three, what the next few years will be and why OVATION 3 is a value-defining chapter for Imunon. The problem, we'll start with the patient. We always have to remain focused on the patient. We have chosen to study newly diagnosed women with ovarian cancer. This is what we call frontline treatment. It follows in the same frontline treatment with maintenance therapy, but we are focusing on women who have just been diagnosed and are seeking the initial treatment, so they're treatment-naive. We know that the way it's been treated at its core hasn't changed for multiple decades. Platinum and taxane chemotherapy plus surgery have been the backbone of treatment. They have saved lives. But we also know when we look to future patients, this really has plateaued in terms of the treatment paradigm.

Stacy LindborgPresident and CEO

There have been many well-run trials with combination treatments, and they have failed to deliver overall survival benefits. Physicians will tell you they will use a drug that has small PFS improvement and no overall survival benefit. For example, bevacizumab, which is frequently used. This really tells you how much there is need and where the bar really should be as we reach the end of our phase III trial and we're seeking to be integrated into the frontline standard of care. Ovarian cancer remains one of the most deadly gynecologic malignancies. Women are diagnosed very late. Too many women are diagnosed in advanced stage.

Stacy LindborgPresident and CEO

Too many relapse, and too many never get the extra years that all of us take for granted as we have milestones and life that we want to see unfold. IL-12 is not a new idea. We're all aware of that. But we also know it's one of the most potent cytokines that exist and is a powerful weapon against cancer, if we want to use that term. It activates cytotoxic T cells and natural killer cells, and it works directly through interferon gamma. In pre-clinical models, the anti-tumor activity is profound, nothing short of profound. We've studied many different tumor types, and we're excited as we ultimately look at our first up, which is ovarian cancer.

Stacy LindborgPresident and CEO

We know that this is also the excitement and really the potential of IL-12 is why many large companies, including AstraZeneca and many others, went after IL-12, and they were approaching this with administering recombinant IL-12 systemically, so directly into the bloodstream. These programs did not fail for a lack of biology. They failed because they could not get to a therapeutic dosing window, and also because these, when delivered systemically, it produced dose-limiting toxicity. There was no therapeutic window. They had cytokine release syndrome and other immune-related injuries that closed the door, and the field, frankly, moved on. The field does what the field will do. You see a complication and a side effect that really is stopping development of an asset, and IL-12 effectively became a cautionary tale for products. Imunon chose to not move on, and we've changed the delivery problem.

Stacy LindborgPresident and CEO

We found a way around the complications of before, and we developed a novel proprietary treatment. IMNN-001 is not a recombinant IL-12 injected into the bloodstream. It's administered as an IL-12-encoded DNA plasmid that's carried in our proprietary delivery system in a nanoparticle, and it's administered locally. Instead of systemically and going around the body, it's actually delivered directly where the cancer resides. It's designed to protect the DNA from degradation, allow it to go into the nucleus of cells, and allow those cells that are within each of these women's bodies to become factories that are naturally, through the immune system, producing IL-12, interferon gamma, and a whole cascade of effects. It drives sustained levels. In our trials, you'll see we are giving them weekly infusions, up to 17 weekly doses, and yet you'll see that the data that we're presenting is out in the years, out to some women living and still in the trial being observed for more than 5 years.

Stacy LindborgPresident and CEO

So sustained delivery of a local IL-12 at the tumor site, and using each woman's immune system to naturally fight the cancer. The hypothesis is simple: put the cytokine where the cancer is, not where the rest of the body has to absorb the cost. And we have been able to show in a 112-patient trial that was randomized against the standard of care, that we have been able to avoid these historic safety barriers and concerns. We're studying Imunon in combination with the standard of care, which women are treated in neoadjuvant chemotherapy and then adjuvant chemotherapy with surgery.

Stacy LindborgPresident and CEO

The final overall survival data from the trial resulted in a median survival in the Imunon arm of 45 months, and in the control arm of 30 months. So a 14.7-month improvement with Imunon treatment. We saw with women who received PARP inhibitors in maintenance therapy, a 24-month improvement over the standard of care, so 56 months versus 41. Again, I can't emphasize this enough. The historic IL-12 safety barrier was overcome with our product. It did not exist in the trial. Our largest trial, 112 women, half on the experimental arm, no cytokine release syndrome, no serious immune-related adverse events. And while we've explored dosing, we actually never hit a dose-limiting toxicity. We're very confident with the dose that we're taking and used in phase II and we're replicating in phase III. And from an oncology standpoint, the IL-12 has been managed by design.

Stacy LindborgPresident and CEO

Put those results in context carefully, very carefully. If phase III is confirmed, if we've confirmed the phase II findings, IMNN-001 would be the first investigational therapy in this setting, in the frontline ovarian space, to deliver a clinically meaningful overall survival benefit in these women that are newly diagnosed. This is in combination with a standard of care that has been used for more than a couple of decades, and in a randomized, well-controlled trial. We have multiple randomized control trials. It would also be a first-in-class IL-12 DNA-mediated immunotherapy in any cancer, and it would be the first late-stage IL-12 program to pair a very favorable safety profile with the median overall survival that I've described. To our knowledge, no other investigational agent has produced an overall survival signal of this size in the frontline setting.

Stacy LindborgPresident and CEO

This is the opportunity, and I would even say it becomes the responsibility for us to see through, and it's why we are working incredibly hard with our partners that are on the frontline, to ensure that we're running a high-quality study. This is a pivotal trial with OS as the primary endpoint. We have two planned interim analyses. We have Fast Track designation and Orphan Drug designation, and the FDA aligned with our plans, which includes the protocol and the statistical analysis plan and all the accompanying documents that go with registration studies. We had an independent DMC, Data Monitoring Committee, recently that recommended the study continue without modification. As I end my concluding remarks, I want to really focus on where as a company we have to live, which is with the patient.

Stacy LindborgPresident and CEO

If OVATION 3 confirms what we've already seen, IMNN-001 holds a promise of giving women more time. Time to go to a wedding, time to spend time with grandchildren, and for many other memories. It's time that the current standard of care has not been able to provide and for a new generation. This is why the morning is built the way it is. We will have Dr. Faller starting. He is our Chief Medical Officer of Imunon and will be focusing on IL-12 biology, why the field walked away, and how TheraPlas and intraperitoneal delivery changed the safety equation. We'll have Dr. Amir Jazaeri from UT MD Anderson Cancer Center talking about translational work and biomarker data, including preliminary findings from patients under his care in the MRD, Minimal Residual Disease, trial that's ongoing.

Stacy LindborgPresident and CEO

He'll report some early clinical findings, MRD status, circulating tumor DNA, and ultimately evidence that the tumor microenvironment is being remodeled. Then we'll have Dr. Premal Thaker from Washington University, who has treated women with IMNN-001 for more than 15 years. She has an immense set of experience with our product, our experimental product, but more broadly, across the field. She will share that experience and data from OVATION 2 and what the survival signal looks like from her perspective as a physician in the OR and also in the clinic. And then lastly, we'll hear from a woman who was treated with IMNN-001. I'll come back at the end and provide the investment thesis and the catalyst and what we're asking of you, but thank you for the opportunity to give these opening remarks, and I would say let's begin.

Stacy LindborgPresident and CEO

I'll introduce our first speaker, Dr. Douglas Faller. He's Imunon's Chief Medical Officer. He's a medical oncologist and scientist. He has spent his career treating patients and stepping into the gap between patient need and providing drugs that you can give in the clinic. He will introduce the powerful potential of IL-12 from first principles. Why this cytokine the entire industry looked unbeatable from the bench, why systemic programs could not be delivered, and then he'll walk you through TheraPlas, the intraperitoneal delivery that we are administering our product through, and why historic IL-12 toxicities are not what we're seeing with IMNN-001.

Douglas FallerChief Medical Officer

Douglas? Thank you, Stacy. Stacy went through the agenda already, and we'll move right into Stacy also had this slide as part of her presentation and covered this.

Douglas FallerChief Medical Officer

As Stacy said, what we're going to be focusing on for the next few minutes are the power of interleukin-12, the problems with its development, and how IMUNON has really completely overcome the barriers to harnessing interleukin-12 as a therapeutic. Also, as Stacy mentioned, this is really the first and only treatment in decades to demonstrate an impact on overall survival in newly diagnosed advanced ovarian cancer. There's been a long, long period of time in which people have tried to improve on the simple carboplatin/paclitaxel regimen that was developed 30 years ago. But all of the additions that have been tried have failed to demonstrate an improvement in survival.

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