Imunon, Inc. Price & Performance (IMNN)

Good morning, everyone, and welcome to Immuneon's full year twenty twenty four financial results and business update conference call. During today's call, management will make forward looking statements regarding Immunon's [indiscernible] 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 the such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast 02/27/2025. Immunon undertakes no obligation to revise or update comments made during this call except as required by law. With that, I would now like to turn the call over to Doctor. Stacy Lindborg, Immune's President and Chief Executive Officer.

Thank you, Peter.

Good morning, everyone. Joining me on this call is Doctor. Douglas Fowler, Immunon's new Chief Medical Officer who joined earlier this month and Dave Gallaro, our Interim Chief Financial Officer, who will review our financial results for 2024.

Mr. Michael Sordugno, the Executive Chairman of our Board and Doctor. Krishit Anwar, our Chief Scientific Officer are also on the line and will be available for Q and A. 2024 was truly an exceptional year Imunon not only in our execution as a company, but also in our deliverables. In July, we announced positive results from our large randomized and controlled [indiscernible] This study evaluated Immunon001's safety and efficacy in women with newly diagnosed advanced ovarian cancer women with Imunon 3C and IV cancer at diagnosis. I am pleased to report that the results far exceeded not only our expectations, but also those of our investigators and medical advisors. These Phase two data are the basis for our optimism for Immuno-one to go forward with our pivotal Phase [indiscernible] which has agreement from the FDA and we plan to initiate this quarter. I want to confirm our focus is to identify the most expeditious path to advance Imunon Towards commercialization potential commercialization, Our commitment to an aggressive timeline for initiation of the Phase three study has the priority of every employee, consultant and advisor at Imunon. Our ambition is supported and reinforced with data from the OVATION-two study that continues as we've previously announced, to get stronger and stronger, And I might add that at some point, could warrant a discussion related to accelerated approval with FDA.

Even though Ovation two was not powered, for statistical significance, when you observe very large treatment effects in a trial, small p values will emerge. As we are observing with Ovation two. I will now spend a few minutes recapping our progress and providing a clinical and regulatory update on Immuno-one Imunon. Following the OVATION-two trial readout, recall we continued to monitor overall survival in OVATION-two per protocol In December, we announced that based on seven additional months of monitoring, the data showed continued improvement in overall survival in the intent to treat population with the benefit in median overall survival over the standard of care, increasing from eleven months to thirteen months. Based on this data, ImmunoN-one has the potential to be the first immunotherapy effective for the treatment of ovarian cancer Doctor. Fowler will provide a review of this data shortly and we are fully committed to any and all paths that lead to our ability to help women who are fighting this horrific disease.

Following our positive end of Phase two meeting and Type C CMC meeting both in the fourth quarter of twenty twenty four we remain engaged with FDA who have provided and collaborative manner In all of these meetings, FDA senior leaders have been engaged, and the FDA took the unusual step to extend an invitation to connect an end to Phase II meeting in person at its headquarters in Silver Spring, Maryland. Earlier this month, we announced new translational data [indiscernible] trial, we know that Immunon-one has a highly beneficial benefit risk ratio And this new data gives added confidence and confirms a few things in women treated with the targeted dose of immunon-one for Phase three. Number one, there's a strong dose response in IL-twelve levels as measured in ascites or the fluid within the micro tumor environment, And this dose response is across five doses of immunon-one that have been studied. Furthermore, IL-twelve levels in women who received one hundred milligrams per meter squared is about twenty percent compared to those who received seventy nine milligrams per meter squared. Which was the previously highest dose studied.

We also observed large increases in down anticancer immune cytokines. Including interferon gamma, our FDA endorsed potency assay and TGF alpha. Based on these data and the compelling clinical data, we have concluded that one hundred milligrams is the dose that will be used in the Phase three study. Another positive aspect of our TheraPlus technology is that it confines the therapeutic in this case IL-twelve to the local regional area of interest. Doing so, we believe, provides for meaningful efficacy and extraordinary safety profile, which has been the holy grail of oncologists The importance of this mechanism, which has been well established in the literature and pursued by many companies, was demonstrated in the study The IL-twelve levels in blood, in women treated with one hundred milligrams per meter squared of immuno-one remain low and unchanged from baseline. Given the safety profile observed to date, this data in terms of IL-twelve levels in blood was expected But this was important to confirm as elevated led to severe toxicity in historical investigational IL-twelve products administered IV. The data generated to date provides unequivocal evidence that ImmunoN-one and the Theraplast technology more broadly works as it was designed to do. Recent translational data shows that the highest amount of IL-twelve across all dose doses studied has been achieved with the dose that will be used in Phase three and the anticipated downstream effect in critical cancer fighting cytokines is occurring Clinical data demonstrate that the life of women treated with M1-one is extended And if replicated in Phase three immunon-one will reset the standard of care for women newly diagnosed.

With ovarian cancer. Based on the strength of data observed in Ovation two, including the strong safety profile, we believe the probability of success is high amongst products entering Phase three. Now I want to turn to our important second Phase two trial the MRD study being run-in partnership with Breakthrough Cancer Foundation. I am pleased to report that the speed of enrollment has picked up This study will provide insight into two important areas. First, early insight into the potential treatment profile of immunon-one administered together with platinum based chemo and Avastin or biosimilar bevacizumab. And number two, the continued benefit of or the benefit of continuing immunon-one treatment in maintenance. If successful, this trial will provide significant insight and approaches that may potentially alter [indiscernible] new combination therapies predictive diagnostics, and early clinical assessment of efficacy. We expect preliminary results later this year Regarding the Phase three study, Ovation three, as I've mentioned, we are on track to initiate treatment with the first patient in the study in March. Within just a few weeks. We have inventory of our investigational product ready for the trial. Following the end of Phase II meeting, the protocol was submitted to the FDA prior to the end of twenty twenty four for final review and the feedback we've received from the FDA on the protocol has been There's been nothing new of substance nor significant points of disagreement.

Everything that needs to be submitted to the FDA and advances starting the trial has been submitted and in short, exactly where we want to be. The Phase three study will enroll women at least 18 years of age newly diagnosed with advanced ovarian cancer, These women will also be candidates for neo adjuvant chemotherapy with histological evidence of epithelial ovarian fallopian tube or primary peritoneal carcinoma with stage 3C or four and in ECOG performance score or Eastern Cooperative Group score of zero, one or two. The primary endpoint will be overall survival And I want to point out that while OS is expected to take longer, than PFS to assess, the advantage is that it is a definitive endpoint There will be no second guessing our results or need for a second confirmational study to support approval. We are enthusiastic about the initial core set of clinical trial sites to be activated early which includes sites that were part of Ovation I and Ovation II And we're also excited to bring new sites on board to accelerate enrollment of the trial The strength of our clinical data is a key point of discussion and this is how we will drive patient recruitment.

There's optimism that Imunon could potentially be a new product on the horizon and reset the standard of care for the frontline treatment of women newly diagnosed with ovarian cancer. If the promised efficacy from Ovation two are replicated and in Phase three. Regarding clinical trial material, the product for is ready for shipment to clinical sites In a recent IND submission, release criteria have been updated with Phase three and commercialization in mind. We've passed all release criteria and with this strategic choice to move the production of active pharmaceutical ingredients or API in house, we are able to keep clinical trial costs extremely low and set the company up for attractive cost of goods. The future commercial setting. With that, I would like to now who will discuss the Phase two OVATION II study including additional survival data But first, I want to formally welcome him to the company's Chief Medical Officer and properly introduce you to him. Doctor. Faller has over thirty years of experience with a rich background in both industry and academia. He is Board Certified Hematologist and Oncologist with extensive global clinical development, regulatory and medical affairs expertise and a unique record of successful translational research.

His broad experience in large pharma and biotech drug and biologics experience covering oncology, immune disorders, hematology, CNS and neuropsychiatry disorders, and genetics disease for all stages of drug development from first in human through product launch and being on the market, working in companies like Takeda, Skyhawk Therapeutics, and Horizon Genomics.

His career also includes pioneering programs in CAR T therapies and RNA splicing modifiers and his academic appointments span two prestigious local institutions Harvard Medical School and Boston University School of Medicine.

He serves as the founding director of the Comprehensive Cancer Center at Boston University underscoring his ability to build from the ground up and fostering environments where innovation thrives. He received his MD from Harvard Medical School and a Ph. In oncology and cancer biology from MIT. And I am confident that with Doctor. Fowler's guidance and leadership, we will not only advance our scientific objectives, but will enhance our team's culture. [indiscernible] Thank you, Stacy. Let me start by saying that my decision to join Immunon was an easy one.

It's a rare opportunity for an oncologist like myself to be able to lead and support a program that already has the groundbreaking data reported by Immunon in 2024. I'm very grateful for this opportunity.

In July, Immunon announced the results of our Phase This large randomized study involving one hundred and twelve newly diagnosed patients with advanced ovarian cancer exceeded expectations. Specifically an improvement in median overall survival of eleven point one months, nearly a year compared to standard of care. This is a clinically meaningful and unprecedented improvement in first line treatment for this deadly disease. For women who were also administered PARP inhibitors, the Immunon-one arm, the median overall survival has not been reached indicating that more than one half of these patients [indiscernible] With some approaching the five year mark since trial initiation. Importantly, doses survival increased by a remarkable seventeen months. These outcomes are particularly significant in a patient population who has not witnessed an advance in frontline treatment which extends patients lives, for more than twenty five years.

More importantly, our OVATION II study is the first study ever to demonstrate an improvement in overall survival in this context.

For a deeper understanding of these data, I encourage you to visit our R and D Day presentation from September 18, [indiscernible] This is available on our website under the News and Investors tab and then under the Scientific Presentations tab. Furthermore, and very exciting, as Stacy mentioned, results from the additional monitoring of patients in Ovation two indicate that the overall survival benefits are not only being maintained in the population of patients treated with Ambionon-one, but have grown in strength providing a strong additional validation of the potential of our novel IL-twelve immunotherapy to represent an historic advance in the treatment of ovarian cancer. Specifically, in the attempt to treat population, the hazard ratio dropped from zero point seven four to zero point six nine. With the median difference in overall survival being extended by thirteen months in patients treated compared to standard of care. In women who were also treated with PARP inhibitors, the hazard ratio dropped from zero point four one to zero point three eight with over half the women in the Imunon arm remaining alive in the trial.

The median in the control arm was thirty seven point one months.

As Stacy referenced earlier in this call, There is a highly favorable benefit risk profile with no elevation of immune related adverse events and with no cytokine release syndrome occurring in any patients having the Immunon-one treatment.

We will further share these important and exciting data at upcoming twenty twenty five ASCO Annual Meeting in June. Clearly, our commitment to OTHATION three is strongly supported by the data I've just described. I look forward to reporting on our progress in the coming months. I'll now turn the call back to Stacy.

Thanks, Douglas.

As mentioned previously, we have taken a number of steps to conserve cash, and align our critical needs with available capital. We're actively working on value added financing and partnerships which will help secure a cash runway that supports our clinical timelines and long term strategic objectives. In addition, we are actively pursuing non dilutive through partnerships, including focusing on Theraplex and Immuno-one. We're having discussions with potential partners with significant investment in oncology drug development, some of which have invested heavily in IL-twelve in the past. We're also exploring geographic partnerships and ways to accelerate development of Immunon-one in other parts of the world. And finally, we intend to leverage the data from the proof of concept study using our novel Placine technology to sell or license that technology Our technology offers multiple advantages of recurrent vaccines. We believe these attributes will be attractive to potential partners to target the development of a cancer vaccine Imunon addition to antigen based vaccines. For example, we announced new data earlier this week from a Phase one clinical trial of our DNA vaccine in the treatment of COVID-nineteen. Results from the Immunon-one hundred and one proof of concept study demonstrate persistent immunogenicity in trial participants and further validate the PlastiM technology.

Immunon-one hundred and one induced to two to fourfold increase in neutralizing antibody titers from baseline through week four a clear and convincing response to the vaccination Immunon continues to show favorable safety profile and given this proof in immunogenicity, early indications of durability of protection, and competitive advantages in the stability of our vaccine at workable temperatures compared with available mRNA vaccines We believe that Immunon-one hundred and one has significant potential as a superior next generation vaccine and will seek potential partnerships for future development. We're excited to share insights from research conducted in 2024 from Placine in April at the twenty twenty five American Association for Cancer Research Meeting. As a final note, we expect any potential financing or business development opportunities to be accomplished in a manner that will allow us together our shareholders, to best accomplish our mission of improving the lives of people with unmet medical needs. Doing so, we believe, will enhance our ability to significantly improve the lives of people through our innovative technology platforms our committed employees and our supportive medical community advisors and researchers. Now I'd like to turn the call over to Dave Gerro, to review our financial results for the full year.

Thank you, Stacy.

Details of Immune's full year 2024 financial results are included in the press release we issued this morning in our Form 10 ks which we filed before the market opened this morning. As of 12/31/2024, Immunon had $5,900,000 in cash and cash equivalents.

With our continued focus on strategically managing our cash, while continuing to advance our programs, we expect our capital resources to fund operations late into the second quarter Research and development expenses were $11,600,000 compared to $11,300,000 for 2023.

The slight increase was driven primarily by increased clinical spend related to Ovation two in addition to startup costs for Ovation three.

General and administrative expenses were $7,500,000 in 2024 compared to $9,700,000 in 2023.

The decrease was primarily driven by decreased professional fees, Net loss for 2024 was $18,600,000 or $1.62 per share, compared to a net loss of $19,500,000 or $2.16 per share for 2023.

With that financial review, I'll turn the call back to Stacy.

Thank you, Dave.

Before I open the call to your questions, I want to remind you of the power of our technology. Immunot-one allows [indiscernible] therapeutic and dose dependent production and release of IL-twelve into the tumor microenvironment. The lack of toxicity shows its advantages over other approaches to IL-twelve delivery such that the ability of Imunon to achieve well tolerated and durable levels of IL-twelve anticancer cytokines could usher in the first Immune based gene therapy for ovarian cancer.

We may have in our hands the first perhaps only immunotherapy that's effective for the treatment of ovarian cancer We've reported favorable and clinically meaningful top line results from Ovation II in women with newly diagnosed ovarian cancer. We're on track to begin our pivotal OVATION-three trial In the first quarter of twenty twenty five, and we have internal GMP manufacturing capability, in place in Huntsville, Alabama which will allow us to produce quality product at an order of magnitude lower cost compared to an external CDMO. Ovarian cancer represents a multibillion dollar unmet medical need.

Our product has been granted fast track designation by the FDA and orphan drug has been established in The U. S. And Europe thus providing additional protected commercial runway. A second Phase two study in ovarian cancer is underway with immuno-one plus Avastin evaluating MRD at second luke laparoscopy. This is largely funded by the Breakthrough Cancer Foundation and will give insight into combination treatment with Avastro nor biosimilar bifacizumab and maintenance therapy with Imunon I'd like to finish with a comment on the strength of Immunon's company's culture which includes the longevity of commitment to Immunon by our employees across levels of the organization. This strength allows us to have a long term view of our past, It brings trust which enables a culture of entrepreneurialism and an ability to move fast and strength of leadership is enabled by candor and data driven decisions, which spans science operations, manufacturing and finance.

With that, I'd like to open the call to your questions. Operator?

We will now begin the question and answer session. On the XPD1.5 variant, And did any of the participants enrolled in the study have prior COVID-nineteen infection? [indiscernible] I'll ask Doctor. Krishita Moore to take this question and I'll add anything on the back end. Krushi? Sure. I'd be happy to. So the loans we have [indiscernible] [indiscernible] your question about reinfection or pre vaccination, that's a very, very important point. Our study started in summer of last year, Jerry, and a lot of patients, all the subjects, the prior infection, prior vaccination. So it's hard to find a naive subject by that time. So yes, they have been and it has been known in case of mRNA that prior infection causes a reduction in the immune responses. So I think that main point is that the levels you are seeing are fairly comparable to what you anticipate in this type of patient population. [indiscernible] Okay. I see. Thank you. That makes sense. And just one follow-up question. Just generally, what is your updated strategy in terms of patient population for the Phase three ovarian cancer study? And any other details you can share about the trial design? Yes. So I'll take that.

Thank you, Joey.

So we have a protocol that's under review, and we expect to be finalized as early as the end of this week at the FDA is targeting a very similar population to Ovation II. And I'll I'll ask Douglas to give a little bit more detail. Certainly, happy to. As Stacy said, I think the most important thing to take away is that our trial design eligibility exclusion factors, is very, very similar to Ovation two. And I mentioned that because as you well know, one of the Rapid ways to get uninterpreterable results to change the way in which you're administering the drug or the patient populations. By keeping this very, very similar to Ovation two, in nearly every respect except size, this guarantees or I shouldn't say guarantees, This gives us the best chance of reproducing and even strengthening the results we got in Ovation. So similar population of patients a 500 patient study as opposed to 112 patients in Ovation two. And the endpoints here as Stacy mentioned earlier, our twofold, two primary endpoints overall survival in the homologous repair deficient population which gave us the strongest overall survival results in Ovation two. And is the second primary endpoint overall survival results in the intent to treat population which includes both HR deficient and HR proficient tumors.

I see. Thank you. That makes lot more sense.

Thanks for answering my questions. Really appreciate it.

Thank you, Jerry.

The next question comes from David Bottz with Zacks SmallCap Research. Please go ahead. Hey, good morning, everyone. [indiscernible] the possibility for accelerated approval and I kind of wanted to dive into that a little bit. You can discuss What pathways there would be available for that? Is it certain patient populations, interim results? What could potentially lead to the possibility for an accelerated approval?

So David, thank you for the question. I'm pleased you're on the call. And I would say that the the thought behind my prepared remarks is really just reflecting on the the evidence that's emerging. So as you know, we released updated overall survival data after seven months after we read out Trial When you look at the strength of evidence in some of these subgroups, for example women that have received PARP inhibitors as part of maintenance therapy We have P values that are emerging that are now, if I recall off the top of my head, that P value is about 0.6. 0.6.

It was really more of a general comment As the data continues to mature, the protocol indicates we will continue to monitor overall survival through into the fourth quarter of this year. We expect that based on the evidence that we've seen that this could continue to grow and there would be a natural time where that would be a conversation with the FDA. So it is not sharing plans at the moment, but really just an observation of the strength of evidence in that, that would be a very natural step to undertake. Douglas, would you like to add?

I'd just add [indiscernible] the one of the major criteria as I'm sure you know that the F has recently [indiscernible] is that a Phase three confirmatory trial be underway when considerations for accelerated approvals off the basis of a smaller study are concerned. And we will be in that position. If the data continue to [indiscernible] and the fact that we can have conversations with the FDA because of fast track [indiscernible] We can take that data back and ensure them that our Phase three confirmatory convergence of a number of events, which would allow us to be in a good position. At that time.

Okay. Is there currently in your protocol In interim analysis, is there a plan for one? Right now, Yes. In Ovation three, there are two Imunon That's right. The critical, we haven't talked a lot about it, but it has some very exciting components to it. So we know from Ovation II that we saw this really extraordinary response in women that are positive for HR deficiency Imunon saw very similar hazard ratio and a clinical effect in women who receive PARP inhibitors. Imunon a very, very consistent group.

And so the protocol allows for a readout first in that subgroup. Which we expect could happen sooner but is currently designed for an all comers population and would then test the ITT population later. But this is something that will continue to be reflecting on carefully from a strategic standpoint. We know that we could choose if this were really in the interest as we were talking with the investors that will be helping fund the complete study that we could choose to go after an HRT focused population that would be a very coherent strategy and a very simple evolution out of this all comers or we could do the full trial and this this trial design is very strong in that manner.

Okay.

So it sounds like you're going to have options after even after the trial gets underway? It's not necessarily one path is defined. You've got the whole study and then if you decide to go down the route that you were just describing, that's possible. Am I understanding that correctly?

Yes. So I've been clear that we need to raise capital to conduct a Phase three trial We designed this trial with an all comers population and that is what we will start with. As we work through our capital and adding money to the balance sheet, We will then decide the path if it's different from our current plan. We will know that we have full endorsement for the all comers population and then that is a seamless transition if we choose to revert to an initial target of HR deficiency. So we'll be well positioned and we'll follow the path that is most appropriate with the capital that we have to use for this trial. They will both be extremely important contributions to the medical community.

Okay. Yes, sounds great. Thanks for taking the questions.

The next question comes from James Molloy with Alliance Global Partners.

Hey guys, thanks for taking my questions.

What are your do you characterize how the partnership environment looks currently sort of vis a vis into fundraise So given the impending cash crunch here, you guys talked about second quarter of this year. And how does that impacting any potential partnership discussions?

Yes. Thanks, James. We've had very successful meetings with institutional investors in the recent past and even prior to this What we hear from them, they appreciate the quality of our recent Phase two data. And we do have viable investors currently that could serve as lead or co leads a financing that are still in discussions with us.

But I think we all appreciate this is a very tough market. It's not just for Immunon, but virtually all.

Micro cap issuers are facing I want to point out two things that are really to our advantage. And what we think will play a significant role in our ability to fund this trial in full Number one, Ovation two, the [indiscernible] [indiscernible] to show an overall survival benefit not just an improvement, but a clinically meaningful prolongation of survival over the standard of care. The second we know that we have the support of FDA, in our plans and to move into Phase three And with these in mind, if we're patient, I believe we will find the appropriate investors to proceed with the trial.

And how does sort of following up on that, how is the the anti vaccine sentiment in the recent administration impact any potential for Plastine and partnerships there? It's been a strange change to be sure.

There is a lot that's evolving. I would say that we have impressive impressive data It's early. The data that we're reporting is it was recently received. We're just starting to explore it and as we make progress, we'll provide timely updates. But we do believe there are important advantages that we bring to to the landscape and that this is a valuable asset for the right partner.

Could I also add that the technology and the platform is not restricted to infectious diseases which seems to be what the current uncertainty is about but would also include such things as cancer vaccines, which are reemerging as a potentially very strong route to care for hard to treat cancers.

Exactly right.

And the comment I made about the meeting we're attending in April, is in fact sharing preclinical data that was done in 2024 in the cancer vaccine front. Krishit, I don't know if you want to add anything to the discussion? [indiscernible] Feedback on that question. Clearly, as that was Doctor. Fowler said that the application to infectious disease maybe as James mentioned about government position. But cancer vaccine is certainly an important application and raising data rising benefits have been published. And we are we will be sharing an AACR data with a mouse model of Can server, we did target some specific antigens of tumor [indiscernible] Parallel to the personalized cancer vaccines and we demonstrate immune response activation and benefit Imunon survival. So [indiscernible] [indiscernible] If there are certain levels government level things that are under our control. But clearly that's an application that's really gaining a lot of credence in the literature. And we have shown that the that approach works at least in the animal models to start with.

I just wanted to add one other comment on this front, James, before you go forward. We've demonstrated proof of concept. This was our target and our goal. But I do want to be clear that Plessine is not our priority within the company. We are focused on IL-twelve and our Phase three study in tiroplasts It is important that we pursue and use the strength is a derivative, I think, as you know, of our Theraplast technology platform.

We saw an opportunity to bring this forward. We view this as an mRNA better but it will be something that we will not be proceeding with as a company.

We will be looking for partnership and or opportunities to bring a non dilutive funding.

But we'll give you updates as we make progress. Excellent. Maybe a final question for Doctor. Feiler.

Maybe some impressive data out of the Phase two, the Phase three just getting going here.

What sort of jumped out at you as sort of the most impressive data that you saw that said, this is the time to be joining ImmunoGen?

Well, thank you for the question, James. I've been practicing oncology for most of my life. And ovarian cancer has been one of these diseases which we're treating today in frontline the same way I treated it when I was in training. Chemotherapy alone and surgery. It's been very frustrating for women. This is a very chemosensitive tumor. We can eliminate the tumor as far as we can see. In a large number of patients we know that it's going to come back. And this data, these data are really the first that I've seen, the Ovation two data which have really impressed me that this is an opportunity to dramatically extend the life of patients. With a relatively short treatment cycle which adds to standard of care and stops that there have been significant important prolongations in patient survival. I won't repeat everything I said in my presentation, but this is really stunning data.

And really offers hope for patients and for the physicians who care for them. It's a very exciting set of data and I'm really thrilled to be able to take this and get an approval for patients [indiscernible] have something which is well tolerable The FDA had no safety concerns How often do you hear the FDA say that? And this is a straightforward path to getting the stroke Thank you for taking the questions.

The next question comes from Jason Kolbert with DeBoral Capital. Please go ahead. Okay, great. So just a couple of quick questions. Stacy, who put together the design of the trial? What I'm getting at is what is the assumed effect and what is the power and how does that translate into the NVAL? That would be helpful.

Yes. Great question, Jason. So we worked with a really very well known group called Berry Consultants. It's out of the founder is on faculty at MD Anderson. They have played a really prominent role in oncology as well as really innovative designs. And we worked with them on this design to allow two shots on goal and really a very strong design, which allows us to act Are using assumptions that are I'd say, more pessimistic than what we're observing right now especially as the data has continued to improve to strengthen Innovation two. So we started with the intent to treat, the initial readout and Really there's always uncertainty in what your control arm will look like. What maybe will occur across the time of the trial running in terms of treatment landscape changing downstream And so we brought in slightly more pessimistic assumptions knowing that we had a trial set up where if if in fact it was stronger than we were assuming we would hit on an early interim. And what we know based on the trial design is that with these realistic, I think assumptions, and these all of our simulations and the effects that were studied would be strong advancements for the medical community.

Right? So they all represent positive value added product but wanting to make sure we have the trial set up to be able to demonstrate that definitively. And the power of our trial right now and the intent to treat population is about ninety five percent and in the HRD population is is higher than that. So we have a very well powered trial, a trial that allows for early readout if there is warranted. And in fact, in both HRD population and intent to treat population and then a final readout of the interims don't yet warrant stopping And another question about when you're selecting CROs and you're assuming enrollment numbers. Can you give us some idea on kind of what guidance you're getting in terms of how long it would take to completely enroll the trial?

So we I think, have probably one of the best insights into enrollment feasibility having just completed Ovation two we have a strong set of sites that are going to be continuing with the trial and through Douglas, we have a proven track record of running trials and really difficult to recruit populations And I would say that we balance not only our own insights from what's realistic from a recruitment standpoint with the sites that we know, but also with then doing a full RFP and working with some large well established CROs that helped us kind of see through their lens. So I do think we're we're confident in our ability to meet the enrollment that we're setting. And I can tell you that Douglas knows I have pretty high expectations for him. That we are going to improve over what we're assuming. But we're going at this pragmatic I think based on our experience. So, Douglas, I don't know if you have anything you want to add. [indiscernible] intentions are to exceed expectations for enrollment. The This is the data Ovation two has already generated excitement and the ability to deliver the drug and the safety of the drug to date have got investigators quite enthusiastic.

So I'm hoping we can go even faster because of excitement among the investigators than our CRO has suggested.

And you mentioned one thing that I'd like to think about a little bit, which is the delivery of the drug. There are so many innovations in terms of drug delivery and keeping drug on-site and on target. Is that an area where you're constantly looking at how you improve the delivery so that you can expand how long the drug is actually on-site on target before it's eliminated from the body or maybe that's not an issue in at all. If you could just talk about that a little bit?

The points you make are really extremely important. And the fact that we can deliver IL-twelve safely which people have been trying to do for twenty years is I think a really impressive testament to where we are right now. We can deliver IL-twelve to a site We don't have the kind of toxicities that that one sees delivering it systemically or even or even locally This is the technology that as Stacy has mentioned that allows us to treat these patients. Room for improvement, room for new innovation, that's certainly something we're interested in, but the platform also lends itself to delivering other hard to deliver cytokines, for example. Things that you could not deliver systemically, but delivering them locally and encapsulated is a potential platform for a number of other cytokines, which have been too toxic to deliver systemic [indiscernible] Jason, this is a gene therapy product. So across those small molecules of protein, you inject and they have a clearance kinetics. But here the cells take up the material, the DNA and then expresses it for a long period of time. So that adds to the durability of the drug. But clearly, like with any drug, improvement can be made, palatlan like is part of this drug resistant that enhances the President's time of the nanoparticles that can be further enhanced.

But the second step is the expression from the cell that's durable. Too. So it's a different type of biologics compared to the small molecules in terms of durability.

Yes. That's exactly where I was going. So thank you. I appreciate that. I'm sure you're always looking at ways to kind of dial that in a little tighter. Thank you.

And Jason, one thing I want to add just for context we have to keep in mind that when we're successful, right, I'll talk very positively. This will be the first IL-twelve, if approved, this would be the first IL-twelve [indiscernible] disease and Be prepared to think about other cancers. Douglas mentioned, of course, the fact that this is a platform and we have the ability to add multiple cytokines we can adapt and with Krushid as our CSO, is the founder of this technology, we have great depth and strength within the company. So, we are keeping line of sight on our future plans, but we're recognizing that this will be a monumental step as the first IL-twelve product that would be approved if we and when we get to that to that place. So that's a very important perspective. Yes.

I'm excited for patients. Thank you. Thank you, Jason. Our next question comes from Kent Dalliver with Brookline Capital Markets.

Good morning.

First question relates to the combination study and the pickup in enrollment. Can you Tell us where where enrollment stands now and then also what is driven the acceleration?

So I'll start with the second question. We have had more sites coming on board We had one site that was had lost some personnel and therefore their clinical support across the board was suffering that they have now been able to reengage So really this is about engaging very well [indiscernible] sites and getting them back running. So we've had MD Anderson as the the lead site, Doctor. Ameer Dazari that has delivered extremely well at his site and now others coming on board. So our goal is to enroll 35 patients this year. It's our corporate goal for the study and that would really be getting us to the point of completing the trial. So we see those as extremely As a goal that we will accomplish it is our it's the goal we've set for ourselves. And I guess the last point I would add is that I do think that the updated data from OVISHION two two is also gives a lot of strength when we have calls with our PIs. They're able to now take take this data and what's being experienced in innovation to and be able to then translate that to women that they're trying to enroll.

I'll also okay. If I can also mention that our recruitment rate has picked up And in addition, as the sites have opened, sites slow site openings have clinical trials ever since the pandemic as I think you know But I can also tell you that we had a IDMC meeting earlier this or at the end of last week in which all patients enrolled were reviewed by an independent committee and the committee's recommendations were to continue the trial as designed, so there have been no safety issues.

Good.

And Stacy, just to be clear, you mentioned a goal of enrolling 35 subjects this year. The enrollment target for this trial remains at 50. Is that correct? 50.

That's correct. So that would get us basically to the the end of the enrollment period.

Fabulous. Thank you. Second question relates to 101 and the topic of expected durability of protection, how can you or can you demonstrate an appealing durability of protection without following the subjects for the full twelve months that I think you have planned? So I might answer your question in another way. And I do think that as we're looking at the people that were enrolled in the trial and we look at their baseline values we know by the early readout in the cellular data and this has been confirmed with with our consultant at Harvard that has so well versed in in the vaccine space and COVID-nineteen effectively, our entire population he would say based on his publications, Doctor. Baruch has been exposed to the virus multiple times and that we know from our baseline data that we see evidence not only of viral burden, but also of treatment with other vaccines. So I think that one of the most important things when we talk about durability to really assess the full ability of our platform to extend durability, which is one one of the components from the preclinical data that we have that we expect to be a differentiator relative to mRNA vaccine platform We believe that this really does need to be in a naive environment or in an environment that already the levels are not so high.

That you're showing this differentiation and that's been the topic of our conversation. So I do think that we'll be looking for ways that we would be proposing our partners in the future to help us elucidate what really should be one of of a handful of value added additions to the vaccine world. [indiscernible] Just to re imagine, Gabe, what exactly as Stacy said, I think we were pleased to see that there is immunogenicity of DNA vaccines. As you know that DNA vaccines seems have not been very effective unless you use a device. Like separation or jet injection device. And we accomplished that with a simple needle injection method. So that's the first thing that the DNA vaccine is immunogenic and safe. Now this was done in SARS CoV-two system, which is as [indiscernible] infection, prior multiple vaccinations, we're not the best system. But certainly, durability wise in animal models really had naive animals. We've seen longer duration on protection also. So it just sets the program now for this proof of concept of antigenicity. Imunon, genicity demonstrates in human and safe to really expand this into other applications where you could further follow for durability also in a in a model that would be not this messy in terms of prior vaccination infection?

So I think that would be a real assessment of the technology of what we designed the animal models in terms of durability to be in a in a different disease to go after. [indiscernible] Thank you. Thanks, Kim.

This concludes our question and answer session.

I would like to turn the conference back over to Stacy Lindborg, President and CEO any closing remarks.

I want to thank everybody for the questions and really the engaging discussion that we had.

And I'll just make very brief. Comments before we close the call. Reflecting on that really most of the industry in ovarian cancer is focused on maintenance therapy or second line we chose to focus on the most significant challenge facing these patients and at the time that we can deliver the greatest value, by altering the course of their life, Conventional wisdom across oncology is to engage as early as possible As a company, we took a bold decision to focus on newly diagnosed patients a decision that's different from most of our peers and we could be distracted to the treatment landscape as a result. As our work in providing a new treatment option with women ovarian cancer progresses and the population's exposure to potential pandemics increase We remain very excited about reporting data from ongoing clinical studies in the upcoming months And I look forward to keeping you appraised of our progress Thank you for joining us today and for your interest in Imunon.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.