Imunon, Inc. (NASDAQ:IMNN) Q4 2024 Earnings Call Transcript

Imunon, Inc. (NASDAQ:IMNN) Q4 2024 Earnings Call Transcript February 27, 2025

Imunon, Inc. beats earnings expectations. Reported EPS is $-0.35, expectations were $-0.36.

Operator: Good morning. My name is Mike, and I will be your operator today. At this time, I would like to welcome you to Imunon, Inc.’s full year 2024 financial results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speakers’ prepared remarks, there will be a question and answer session. Release your mute function to allow the signal to reach our equipment. Again, please note this event is being recorded. I would now like to turn the call over to Peter Vazzo, of ICR Healthcare, Investor Relations representative for Imunon, Inc. Please go ahead.

Peter Vazzo: Thank you, Mike. Good morning, everyone, and welcome to Imunon, Inc.’s full year 2024 financial results and business update conference call. During today’s call, management will make forward-looking statements regarding Imunon, Inc.’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, February 27, 2025. Imunon, Inc. 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 Dr. Stacy Lindborg, Imunon, Inc.’s President and Chief Executive Officer.

Stacy Lindborg: Thank you, Peter. Good morning, everyone. Joining me on this call is Dr. Douglas Fowler, Imunon, Inc.’s new Chief Medical Officer who joined earlier this month, and Dave Gaiero, our interim Chief Financial Officer who will review our financial results for 2024. Mr. Michael Tardugno, the Executive Chairman of our Board, and Dr. Khursheed Anwer, our Chief Scientific Officer, are also on the line and will be available for Q&A. 2024 was truly an exceptional year for Imunon, Inc., 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 Phase 2 OVATION 2 study. This study evaluated Imunon-001’s safety and efficacy in women with newly diagnosed advanced ovarian cancer, women with stage 3C and 4 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 advisers. These Phase 2 data are the basis for our optimism for Imunon-001 to go forward with our pivotal Phase 3 study, 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-001 towards potential commercialization. Our commitment to an aggressive timeline for initiation of the Phase 3 study has the priority of every employee, consultant, and adviser at Imunon, Inc. Our ambition is supported and reinforced with data from the OVATION 2 study that continues, as we previously announced, to get stronger and stronger, and I might add that at some point, could warrant a discussion related to accelerated approval with the FDA.

Even though OVATION 2 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 2. I will now spend a few minutes recapping our progress and providing a clinical and regulatory update on Imunon-001. Following the OVATION 2 trial readout, recall we continued to monitor overall survival in OVATION 2 per protocol. In December last year, 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 11 months to 13 months. Based on this data, Imunon-001 has the potential to be the first immunotherapy effective for the treatment of ovarian cancer.

Dr. 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 2 meeting and Type C CMC meeting both in the fourth quarter of 2024, we remain engaged with the FDA, who have provided supportive feedback in a timely 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 conduct an end-of-Phase 2 meeting in person at its headquarters in Silver Spring, Maryland. Earlier this month, we announced new translational data from OVATION 2. Based on the exciting data from this trial, we know that Imunon-001 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 Imunon-001 for Phase 3.

Number one, there’s a strong dose response in IL-12 levels as measured in ascites or the fluid within the microtumor environment, and this dose response is across five doses of Imunon-001 that have been studied. Furthermore, IL-12 levels in women who received 100 milligrams per meter squared is about 20% compared to those who received 79 milligrams per meter squared, which was the previously highest dose studied. We also observed large increases in downstream 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 100 milligrams is the dose that will be used in the Phase 3. Another positive aspect of our TheraPlus technology is that it confines the therapeutic, in this case IL-12, to the local regional area of interest.

Doing so, we believe, provides for meaningful efficacy and an 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-12 levels in blood in women treated with 100 milligrams per meter squared of Imunon-001 remain low and unchanged from baseline. Given the safety profile observed to date, this data in terms of IL-12 levels in blood was expected, but this was important to confirm as elevated systemic IL-12 levels led to severe toxicity in historical investigational IL-12 products administered IV. The data generated to date provides unequivocal evidence that Imunon-001 and the TheraPlus technology more broadly works as it was designed to do.

Recent translational data shows that the highest amount of IL-12 across all doses studied has been achieved with the dose that will be used in Phase 3, and the anticipated downstream effect in critical cancer-fighting cytokines is occurring. Clinical data demonstrate that the life of women treated with Imunon-001 is extended, and if replicated in Phase 3, Imunon-001 will reset the standard of care for women newly diagnosed with ovarian cancer. Based on the strength of data in OVATION 2, including the strong safety profile, we believe the probability of success is high amongst products entering Phase 3. Now I want to turn to our important second Phase 2 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 Imunon-001 administered together with platinum-based chemo and Avastin or biosimilar bevacizumab. And number two, the continued benefit of continuing Imunon-001 treatment in maintenance. If successful, this trial will provide significant insight and approaches that may potentially alter the treatment landscape, including new combination therapies, predictive diagnostics, and early clinical assessment of efficacy. We expect preliminary results later this year. Regarding the Phase 3 study, OVATION 3, 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 2 meeting, the protocol was submitted to the FDA prior to the end of 2024 for final review. And the feedback we’ve received from the FDA on the protocol has been helpful and focused in nature. There’s been nothing new of substance nor significant points of disagreement. Everything that needs to be submitted to the FDA in advance of starting the trial has been submitted, and in short, we’re exactly where we want to be. The Phase 3 study will enroll women at least 18 years of age, newly diagnosed with advanced ovarian cancer. These women will also be candidates for neoadjuvant chemotherapy with histological evidence of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with stage 3C or 4, and an ECOG performance score or Eastern Cooperative Group score of 0, 1, or 2.

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 1 and OVATION 2, 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-001 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 2 is replicated in Phase 3.

Regarding clinical trial material, the product for OVATION 3 is ready for shipment to clinical sites. In a recent IND submission, release criteria have been updated with Phase 3 and commercialization in mind. We’ve passed all release criteria, and with the 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 in the future commercial setting. With that, I would like to now turn the call over to Dr. Douglas Fowler, who will discuss the Phase 2 OVATION 2 study, including additional survival data. But first, I want to formally welcome him to the company as Chief Medical Officer and properly introduce you to him.

Dr. Fowler has over 30 years of experience with a rich background in both industry and academia. He’s a 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 genetic diseases 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 PhD in oncology and cancer biology from MIT, and I am confident that with Dr. Fowler’s guidance and leadership, we will not only advance our scientific objectives but will enhance our team’s culture. Seagullis.

Douglas Fowler: Thank you, Stacy. Let me start by saying that my decision to join Imunon, Inc. 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 Imunon, Inc. in 2024. I’m very grateful for this opportunity. In July, Imunon, Inc. announced the results of our Phase 2 study OVATION 2. This large randomized study involving 112 newly diagnosed patients with advanced ovarian cancer exceeded expectations. Specifically, an improvement in median overall survival of 11.1 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, in the Imunon-001 arm, the median overall survival has not been reached, indicating that more than one half of these patients in the Imunon-001 arm are still with us, with some approaching the five-year mark since trial initiation. Importantly, for those receiving at least 20% of the planned Imunon-001 dose, survival increased by a remarkable 17 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 25 years. More importantly, our OVATION 2 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&D day presentation from September 18 last year.

This is available on our website under the news and investors tab and then under the scientific presentations tab. Furthermore, and very excitingly, as Stacy mentioned, results from the additional monitoring of patients in OVATION 2 indicate that the overall survival benefits are not only being maintained in the population of patients treated with Imunon-001, but have grown in strength, providing a strong additional validation of the potential of our novel IL-12 immunotherapy to represent a historic advance in the treatment of ovarian cancer. Specifically, in the intent-to-treat population, the hazard ratio dropped from 0.74 to 0.69, with the median difference in overall survival being extended by 13 months in patients treated with Imunon-001 compared to standard of care.

In women who were also treated with PARP inhibitors, the hazard ratio dropped from 0.41 to 0.38, with over half the women in the Imunon-001 arm remaining alive in the trial. The median in the control arm was 37.1 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 Imunon-001 treatment. We will further share these important and exciting data at the upcoming 2025 ASCO annual meeting in June. Clearly, our commitment to accelerating initiation of the Phase 3 study OVATION 3 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.

Stacy Lindborg: Thanks, Douglas. As mentioned previously, we have taken a number of steps to conserve cash and align our critical needs with available capital. Our cash runway, accounting for costs associated with starting the Phase 3 trial in March, extends late into June. 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 funding through partnerships, including focusing on TheraPlus and Imunon-001. We’re having discussions with potential partners with significant investment in oncology drug development, some of which have invested heavily in IL-12 in the past.

We’re also exploring geographic partnerships and ways to accelerate the development of Imunon-001 in other parts of the world. And finally, we intend to leverage the data from the proof-of-concept study using our novel Plasmin technology to sell or license that technology. Our technology offers multiple advantages over current vaccines. We believe these attributes will be attractive to potential partners to target the development of a cancer vaccine in addition to antigen-based vaccines. For example, we announced new data earlier this week from a Phase 1 clinical trial of our DNA vaccine in the treatment of COVID-19. Results from the Imunon-101 proof-of-concept study demonstrate persistent immunogenicity in trial participants and further validate the Plasmin technology.

Imunon-101 induced a two to fourfold increase in neutralizing antibody titers from baseline through week four, a clear and convincing response to the vaccination. Imunon continues to show a favorable safety profile, and given this proof of 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 Imunon-101 has significant potential as a superior next-generation vaccine and we’ll seek potential partnerships for future development. We’re excited to share insights from research conducted in 2024 from Plasmin in April at the 2025 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 with 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 Gaiero to review our financial results for the full year.

Dave Gaiero: Thank you, Stacy. Details of Imunon, Inc.’s full year 2024 financial results are included in the press release we issued this morning and in our Form 10-K, which we filed before the market opened this morning. As of December 31, 2024, Imunon, Inc. had $5.9 million 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 of 2025. Research and development expenses were $11.6 million in 2024 compared to $11.3 million for 2023. The slight increase was driven primarily by increased clinical spend related to OVATION 2, in addition to startup costs for OVATION 3. General and administrative expenses were $7.5 million in 2024 compared to $9.7 million in 2023.

The decrease was primarily driven by decreased professional fees and decreased employee-related expenses. Net loss for 2024 was $18.6 million or $1.62 per share, compared to a net loss of $19.5 million or $2.16 per share for 2023. With that financial review, I’ll turn the call back to Stacy.

Stacy Lindborg: Thank you, Dave. Before I open the call to your questions, I want to remind you of the power of our technology. Imunon-001 allows durable therapeutic and dose-dependent production and release of IL-12 into the tumor microenvironment. The lack of toxicity shows its advantages over other approaches to IL-12 delivery, such that the ability of Imunon-001 to achieve well-tolerated and durable levels of IL-12 and other 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 2 in women with newly diagnosed ovarian cancer.

We’re on track to begin our pivotal OVATION 3 trial in the first quarter of 2025, and we have an 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 status has been established in the US and Europe, thus providing additional protected commercial runway. A second Phase 2 study in ovarian cancer is underway with Imunon-001 plus Avastin to evaluate MRD at second laparoscopy. This is largely funded by the Breakthrough Cancer Foundation and will give insights into combination treatment with Avastin or biosimilar bevacizumab and maintenance therapy with Imunon-001.

I’d like to finish with a comment on the strength of Imunon, Inc.’s company culture, which includes the longevity of commitment to Imunon, Inc. by our employees at all levels of the organization. This strength allows us to have a long-term view of our path. 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?

Q&A Session

Operator: We will now begin the question and answer session. The first question comes from Emily Bodnar with H.C. Wainwright. Please go ahead.

Emily Bodnar: Hi. Good morning. This is Joey on for Emily. Could you discuss the COVID booster neutralizing antibody data in the context of what would be expected from the approved mRNA vaccines on the PB1.5 variant? And did any of the participants enrolled in the study have prior COVID-19 infection?

Stacy Lindborg: Yes. I’ll ask Dr. Khursheed Anwer to take this question, and I’ll add anything on the back end. Khursheed?

Khursheed Anwer: Sure. I’d be happy to. So the levels we have seen in neutralizing antibody response from baseline are on par with the mRNA vaccine. And your question about pre-infection or pre-vaccination, that’s a very, very important point. Our study started in the summer of last year, Joey, and a lot of patients, all the subjects, you know, had prior infection, prior vaccination. So it was hard to find a naive subject by that time. So yes, they have been, and it has been known in the case of mRNA that prior infection causes a reduction in the immune responses. So I think the main point is that the level we are seeing is fairly comparable to what you’re anticipating with this type of patient population, expecting RNA vaccine bulk.

Emily Bodnar: 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 3 ovarian cancer study? And any other details you can share about the trial design?

Stacy Lindborg: Yeah. 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. The FDA is targeting a very similar population to OVATION 2. And I’ll ask Douglas to give a little bit more detail.

Douglas Fowler: 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 2. And I mention that because, as you well know, one of the rapid ways to get uninterpretable results is to change the way in which you’re administering the drug or the patient populations. So by keeping this very, very similar to OVATION 2, 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 2. So similar population of patients, a 500-patient study as opposed to 112 patients in OVATION 2. And the endpoints here, as Stacy mentioned earlier, are twofold: two primary endpoints, overall survival in the homologous repair deficient population, which gave us the strongest overall survival results in OVATION 2, and as a second primary endpoint, overall survival results in the intent-to-treat population, which includes both HR deficient and HR proficient tumors.

Emily Bodnar: I see. Thank you. That makes a lot more sense. Thanks for answering my questions. Really appreciate it.

Stacy Lindborg: Thank you, Joey.

Operator: The next question comes from David Bautz with Zacks SmallCap Research. Please go ahead.

David Bautz: Hey, good morning, everyone. Thanks for the overview this morning. It was really helpful. Stacy, in your prepared remarks, you had mentioned the possibility for accelerated approval, and I kind of wanted to dive into that a little bit. Maybe you can discuss what pathways there would be available for that? Is it certain patient populations, interim results, you know, what could potentially lead to the possibility for an accelerated approval?

Stacy Lindborg: So, David, thank you for the question. I’m pleased you’re on the call. And I would say that the thought behind my prepared remarks is really just reflecting on the evidence that’s emerging. So as you know, we released updated overall survival data after seven months after we read off the 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. It was really more of a general comment that as the data continues to mature, you know, 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, 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 it, that would be a very natural step to undertake. Douglas, would you like to add?

Douglas Fowler: I just add that one of the major criteria, as I’m sure you know, that the FDA has recently enforced is that a Phase 3 confirmatory trial be underway when considerations for accelerated approvals off the basis of a Phase 2 study are concerned. And we will be in that position if the data continue to strengthen and the fact that we can have conversations with the FDA because of fast-track approval, we can take that data back and ensure them that our Phase 3 confirmatory study is underway. So it’ll be a convergence of a number of events which would allow us to be in a good position at that time.

David Bautz: Okay. Is there currently in your protocol an interim analysis? Is there a plan for one right now?

Douglas Fowler: Yes. In OVATION 3, there are two interim analyses and a final analysis if necessary.

Stacy Lindborg: That’s right. The protocol, we’ve been talking a lot about it, but it has some very exciting components to it. So we know from OVATION 2 that we saw this really extraordinary response in women that are positive for HR deficiency and saw very similar hazard ratio and a clinical effect in women who receive PARP inhibitors. It’s a very, very consistent group. And so the protocol allows for, you know, 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 we 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 HRD-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 trial design is very strong in that manner.

David Bautz: Okay. So it sounds like you’re going to have options 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, then that’s possible. Am I understanding that correctly?

Stacy Lindborg: Yeah. So I’ve been clear that we need to raise capital to conduct a Phase 3 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 will 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.

David Bautz: Okay. Yeah. Sounds great. Thanks for taking my questions.

Operator: The next question comes from James Molloy with Alliance Global Partners. Please go ahead.

James Molloy: Hey, guys. Thanks for taking my questions. What are your do you characterize how the partnership environment looks currently sort of vis-a-vis a financial fundraise? So given the impending cash crunch here, you guys talked about the second quarter of this year. And how does that how is that impacting any potential partnership discussions?

Stacy Lindborg: Yeah. 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 2 data. And we do have viable investors currently that could serve as lead or co-leads in 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 Imunon, Inc., but virtually 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 2 is the only trial 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 the FDA in our plans to move into Phase 3, and with these in mind, if we’re patient, I believe we will find the appropriate investors to proceed with the trial.

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

Stacy Lindborg: Seems there is a lot that’s evolving. I would say that we have 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 the landscape and that this is a valuable asset for the right partner.

Douglas Fowler: 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 potentially very strong routes to care for hard-to-treat cancers.

Stacy Lindborg: 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 2020 with the Plasmin in the cancer vaccine. Khursheed, I don’t know if you want to add anything to the discussion.

Khursheed Anwer: No. No. I think very valuable feedback on that question. Clearly, as Dr. Fowler said, the application to infectious disease may be, as you know, James mentioned about government perception. But cancer vaccines certainly important application and raising data rising benefits would be in publishing. We are we will be sharing an ASR data with a mouse model of cancer, we did target some specific antigens of tumor. Anyway, parallel to personalized cancer vaccines, and we demonstrate immune response activation and benefiting survival. So that’s clearly, as Dr. Fowler said, and I can work that that as an application, and then you can branch into. If there are certain levels government level things that are not in our control. But clearly, that’s an application that we getting a lot of credits in the literature. And we have shown that the approach works at least in the animal models to start with.

Stacy Lindborg: I just want to make one other comment on this front, James, before you go forward. You know, we’ve demonstrated proof of concept. This was our target and our goal. But I do want to be clear that Plasmin is not our priority within the company. We are focused on IL-12 and our Phase 3 study, and TheraPlus. It is important that we pursue and use the strength of Plasmin as a derivative, I think, as you know, of our TheraPlus technology platform. We saw an opportunity to bring this forward. We view this as an mRNA better platform, 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.

James Molloy: Excellent. Maybe a final question for Dr. Fowler. Maybe some impressive data out of the Phase 2. The Phase 3 just getting going here. What sort of jumped out at you as sort of the most impressive data that you saw that said, alright, this is the time to be joining Imunon, Inc.?

Douglas Fowler: 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, but we know that it’s going to come back. And this data, these data are really the first that I’ve seen, the OVATION 2 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 go through 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 to have something which they 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 drug.

James Molloy: Thank you for taking the questions.

Stacy Lindborg: Thanks, James.

Operator: The next question comes from Jason Kolbert with DeBoral Capital. Please go ahead.

Jason Kolbert: Hi. Can you hear me?

Operator: Yes. We can hear you. Now we

Jason Kolbert: 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 end value? That would be helpful.

Stacy Lindborg: Yeah. 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, you know, two shots on goal and really a very strong design, which allows us to act quickly if we see the same strength of effect in the HRD positive subgroup, then we would be able to read that out early and file for accelerated approval while the all-comers continued to mature. So that was a very important part of the design, which did include a lot of clinical trial simulations. So you want a really good sense of when you’re putting together these kinds of designs.

The assumptions that we undertook are using assumptions that are, I’d say, more pessimistic than what we’re observing right now, especially as the data’s continued to improve to strengthen in OVATION 2. 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 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, you know, 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 products 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 95%, and in the HRD population 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 if the interims don’t yet warrant stopping.

Jason Kolbert: 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?

Stacy Lindborg: So we know, I think, have probably one of the best insights into enrollment feasibility having just completed OVATION 2. 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 in really difficult-to-recruit populations. And I would say that we balance not only our own insight from a, you know, 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, you know, kind of see through their lens. So I do think we’re confident in our ability to meet the, you know, 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 we’re going to improve over what we’re assuming. But we’re going at this pragmatically, I think, based on our experience. So, Douglas, I don’t know if you have anything you want to add.

Douglas Fowler: Oh, my intentions are to exceed expectations for enrollment. The data from OVATION 2 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.

Jason Kolbert: 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, you know, 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 at all. If you could just talk about that a little bit.

Douglas Fowler: The points you make are really extremely important. And the fact that we can deliver IL-12 safely, which people have been trying to do for 20 years, is, I think, a really impressive testament to where we are right now. We can deliver IL-12 to a site. We don’t have the kind of toxicities that one sees delivering it systemically 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 systemically.

Khursheed Anwer: Stacy? So if I may add, please. You know, Jason, this is a gene therapy product. So across those small molecules of protein, you know, you inject and they have a clearance kinetics. But here, the cells take up the material, the DNA, and then expresses it for long periods of time. So that adds to the durability of the drug. But clearly, like with any drug, improvement can be made. You know, polyethylene glycol is part of this service system that enhances the presence time of the nanoparticles that can be further enhanced, but, you know, 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.

Jason Kolbert: Yeah. 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.

Stacy Lindborg: That’s absolutely fine. One thing I want to add just for context, we have to keep in mind that when we’re successful, right? I’ll talk up very positively. This will be the first IL-12, if approved. This would be the first IL-12 product in any disease and the first immunotherapy gene therapy in ovarian cancer. So we will be moving forward progress, and I expect we’ll be able to then rapidly 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 Khursheed, our CSO, as 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-12 product that would be approved if and when we get to that place. So that’s a very important perspective.

Jason Kolbert: Yeah. I’m excited for patients. Thank you.

Stacy Lindborg: Thank you, Jason.

Operator: Our next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead.

Kemp Dolliver: Good morning. First question relates to the combination study and the pickup in enrollment. Can you tell us where enrollment stands now, and then also what has driven the acceleration?

Stacy Lindborg: So I’ll start with the second question. We have had more sites coming on board. We had one site that had lost some personnel, and therefore their clinical support across the board was suffering, but they have now been able to reengage. So really, this is about engaging very well-established sites and getting them back running. So, you know, we’ve had MD Anderson as the lead site, Dr. Amir 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 very it’s 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 one I would add is that I do think that the updated data from OVATION 2 is also gives a lot of strength when we have calls with our PIs. They’re able to now take this data and what’s being experienced in OVATION 2 and be able to then translate that to women that they’re trying to enroll.

Douglas Fowler: I’ll also, 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 like, clinical trials ever since the pandemic, as I think, you know. But we I can also tell you that we had an 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.

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

Stacy Lindborg: Fifty. That’s correct. That’s correct. So that would get us basically to the end of the enrollment period.

Kemp Dolliver: Fabulous. Thank you. Second question relates to Imunon-101. And you know, the topic of expected durability of protection. You know, how can you or can you demonstrate an appealing durability of protection without following the subjects for the full 12 months that I think you have planned?

Stacy Lindborg: 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 that this has been confirmed with our consultant at Harvard that is so well-versed in the vaccine space and COVID-19. You know, effectively, our entire population, he would say based on his publications, Dr. Baruch, has been exposed to the virus multiple times and that, you know, 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 of the components from the preclinical data that we have that we expect to be a differentiator relative to the 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 is 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 a handful of value-added additions to the vaccine world.

Khursheed Anwer: Yeah. Just to reimagine, they’ve got exactly as Stacy said. I think you were pleased to see that there is an immunogenicity of DNA vaccine. As you know, that DNA vaccines 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-2 system, which is, as we mentioned, prior infection, prior multiple vaccinations. So not the best system, but certainly the ability to rise in animal models where you had naive animals, we’ve seen longer duration on protection also. So it just kept the program now for from this proof of concept of NQG and the chemistry demonstrates in human and says, to really expand this into other applications where you could study further follow for the durability also in a model that would be not this messy, you know, in terms of prior vaccination infection.

So I think that would be a real assessment of the technology of what the time the animal model is in terms of durability would be in a different drug and disease to go after. After this POC.

Kemp Dolliver: Thank you.

Stacy Lindborg: Thanks, Kemp.

Operator: This concludes our question and answer session. I would like to turn the conference back over to Stacy Lindborg, President and CEO, for any closing remarks.

Stacy Lindborg: 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 in ovarian cancer, 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 with 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, Inc. Have a great day, everybody.

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