Imunon - Earnings Call - Q4 2024

Executive Summary

• IMUNON reported FY 2024 results and reiterated pivotal milestones: initiating the Phase 3 OVATION III trial for IMNN-001 in advanced ovarian cancer in Q1 2025, with first patient dosing targeted for March, following positive End-of-Phase 2 and Type C CMC interactions with FDA.
• Clinical efficacy continued to strengthen: the OVATION 2 ITT hazard ratio improved to 0.69 (from 0.74) with a median overall survival extension of 13 months vs standard of care; in the PARP-treated subset, HR fell to 0.38 with median OS not reached in the IMNN-001 arm, underscoring robust survival signals and a favorable safety profile with no cytokine release syndrome.
• FY 2024 net loss was $18.6M ($1.62 per share) and year-end cash was $5.9M; management guided cash runway “late into June”/late Q2 2025 while actively pursuing financing and partnerships, a shift from Q3 2024’s “into Q3 2025” commentary, highlighting funding urgency as a near-term stock catalyst.
• Translational data confirmed a dose-dependent IL‑12 mechanism at 100 mg/m² (≈20% higher local IL‑12 vs 79 mg/m²) with downstream IFN‑γ/TNF‑α increases and negligible systemic IL‑12 exposure—reinforcing TheraPlas’ localized efficacy/safety promise and Phase 3 dose selection.
• The company emphasized potential accelerated approval discussions contingent on further maturation of survival data and concurrent Phase 3 enrollment; the trial includes two interim analyses, and design allows earlier HRD subgroup readout while ITT matures.

What Went Well and What Went Wrong

What Went Well

• Strengthening survival efficacy: “hazard ratio dropped from 0.74 to 0.69” with median OS extended by 13 months; PARP subgroup HR improved to 0.38, with IMNN-001 median OS not reached; no cytokine release syndrome reported.
• FDA engagement and CMC readiness: Positive End-of-Phase 2 meeting and Type C CMC sign-off; FDA accepted IFN‑γ potency assay for Phase 3 and commercial release, and agreed on comparability strategy for in-house manufacturing—de‑risking Phase 3 supply and future BLA.
• Dose mechanism validated: “IL‑12 levels…about 20% higher” at 100 mg/m² vs 79 mg/m²; increasing local IFN‑γ/TNF‑α with minimal systemic IL‑12 confirms localized action and supports Phase 3 dose selection.

What Went Wrong

• Cash runway compressed: Q3 indicated runway “into Q3 2025” vs Q4 update of “late into June”/late Q2 2025; management flagged tough microcap financing markets, elevating near-term dilution/partnership risk.
• Continued losses: FY net loss $18.6M (vs $19.5M prior year), with operating expenses $19.1M; quarterly net losses of $4.8–$4.9M persisted in Q2–Q3, underscoring dependence on external capital.
• Estimates unavailable: S&P Global consensus EPS/revenue estimates could not be retrieved; inability to benchmark to Street increases uncertainty on “beat/miss” characterization for near-term trading (SPGI access limit).

Transcript

Operator (participant)

Good morning. My name is Mike, and I will be your operator today. At this time, I would like to welcome you to Imunon's full-year 2024 financial results conference call. All lines have been placed on mute to prevent any background noise. Following the speaker's prepared remarks, there will be a question-and-answer session. You may press star one on your phone to ask a question at that time. Please keep in mind, if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment. Again, that's star one to ask a question during the Q&A session. Please note this event is being recorded. I would now like to turn the call over to Peter Vozzo of ICR Healthcare, investor relations representative for Imunon. Please go ahead.

Peter Vozzo (Head of Investor Relations)

Thank you, Mike. Good morning, everyone, and welcome to Imunon's full-year 2024 financial results and business update conference call. During today's call, management will make forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, February 27, 2025. Imunon 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's President and Chief Executive Officer. Stacy?

Stacy Lindborg (President and CEO)

Thank you, Peter. Good morning, everyone. Joining me on this call is Dr. Douglas Faller, Imunon'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, 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. The study evaluated IMNN-001's safety and efficacy in women with newly diagnosed advanced ovarian cancer, women with stage IIIC 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 2 data are the basis for our optimism for IMNN-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 IMNN-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 advisor of Imunon. Our ambition is supported and reinforced with data from the OVATION 2 study that continues, as we previously announced, to get stronger and stronger. I might add that at some point could warrant a discussion related to accelerated approval with 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 IMNN-001. Following the OVATION 2 trial read-out, 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, IMNN-001 has the potential to be the first immunotherapy effective for the treatment of ovarian cancer.

Dr. Faller 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 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 IMNN-001 has a highly beneficial benefit-risk ratio.

This new data gives added confidence and confirms a few things in women treated with the targeted dose of IMNN-001 for Phase 3. Number one, there is a strong dose response in IL-12 levels, as measured in ascites, or the fluid within the micro tumor environment. This dose response is across five doses of IMNN-001 that have been studied. Furthermore, IL-12 levels in women who received 100 mg per meter squared is about 20% higher compared to those who received 79 mg per meter squared, which was the previously highest dose studied. We also observed large increases in downstream anti-cancer 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 100 mg is the dose that will be used in the Phase 3 study.

Another positive aspect of our TheraPlas 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 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 mg per meter squared of IMNN-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. 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 IMNN-001 and the TheraPlas 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 IMNN-001 is extended. If replicated in Phase 3, IMNN-001 will reset the standard of care for women newly diagnosed with ovarian cancer. Based on the strength of data observed 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 Break Through 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 IMNN-001 administered together with platinum-based chemo and Avastin or biosimilar bevacizumab. Number two, the continued benefit of or the benefit of continuing IMNN-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. 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. 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 IIIC or IV, and an ECOG performance score or Eastern Cooperative Oncology Group score of 0, 1, or 2. The primary endpoint will be overall survival.

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. We are 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. This is how we will drive patient recruitment. There is optimism that IMNN-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 three and commercialization in mind. We have passed all release criteria. 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 in the future commercial setting. With that, I would like to now turn the call over to Dr. Douglas Faller, who will discuss the Phase 2 OVATION 2 study, including additional survival data. First, I want to formally welcome him to the company as Chief Medical Officer and properly introduce you to him. Dr. Faller 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 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 Therapeutics. His career also includes pioneering programs in CAR-T therapies and RNA splicing modifiers. 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. I am confident that with Dr. Faller's guidance and leadership, we will not only advance our scientific objectives, but will enhance our team's culture. Douglas.

Douglas Faller (CMO)

Thank you, Stacy. Let me start by saying that my decision to join Imunon 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 in 2024. I'm very grateful for this opportunity. In July, Imunon 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 IMNN-001 arm, the median overall survival has not been reached, indicating that more than one half of these patients in the IMNN-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 IMNN-001 doses, 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 18th of 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 IMNN-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 0.74-0.69, with the median difference in overall survival being extended by 13 months in patients treated with IMNN-001 compared to standard of care.

In women who were also treated with PARP inhibitors, the hazard ratio dropped from 0.41-0.38, with over half the women in the Imunon 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 (President and CEO)

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 three 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 TheraPlas and IMNN-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 development of IMNN-001 in other parts of the world. Finally, we intend to leverage the data from the proof of concept study using our novel PlaCCine 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 IMNN-101 proof-of-concept study demonstrate persistent immunogenicity in trial participants and further validate the PlaCCine technology. IMNN-101 induced a two- to four-fold increase in neutralizing antibody titers from baseline through week four, a clear and convincing response to the vaccination. Imunon continues to show favorable safety profiles.

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 IMNN-101 has significant potential as a superior next-generation vaccine and will seek potential partnerships for future development. We are excited to share insights from research conducted in 2024 from PlaCCine 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.

Dave Gaiero (Interim CFO)

Thank you, Stacy. Details of Imunon'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 31st, 2024, Imunon 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 for 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 (President and CEO)

Thank you, Dave. Before I open the call to your questions, I want to remind you of the power of our technology. IMNN-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 IMNN-001 to achieve well-tolerated and durable levels of IL-12 and other anti-cancer 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 are on track to begin our pivotal OVATION 3 trial in the first quarter of 2025. 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 multi-billion dollar unmet medical need. Our product has been granted Fast Track designation by the FDA, and orphan drug status has been established in the U.S. and Europe, thus providing additional protected commercial runway. A second Phase 2 study in ovarian cancer is underway, with IMNN-001 plus Avastin evaluating MRD at second look 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 IMNN-001.

I'd like to finish with a comment on the strength of Imunon's company's culture, which includes the longevity of commitment to Imunon 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. 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.

Operator (participant)

We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then two. At this time, we'll pause momentarily to assemble our roster. The first question comes from Emily Bodnar with H.C. Wainwright. Please go ahead.

Hi, good morning. This is Joey on for Emily. Thanks for taking our questions. Could you discuss the COVID booster neutralizing antibody data in the context of what would be expected from the approved mRNA vaccines on the XBB.1.5 variant? And did any of the participants enrolled in the study have prior COVID-19 infection?

Stacy Lindborg (President and CEO)

Yeah. I'll ask Dr. Khursheed Anwer to take this question, and I'll add anything on the back end. Khursheed?

Khursheed Anwer (EVP and Chief Science Officer)

Sure. I'd be happy to. The levels we have seen in neutralizing antibody response for baseline are in ballpark with the mRNA vaccine. 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, that had prior infection, prior vaccination. It's hard to find a naive subject by that time. Yes, they have been, and it has been known in the case of mRNA that prior infection causes a reduction in the immune responses. I think the main point is that the levels we have seen are fairly comparable to what you anticipate in this type of patient population with respect to mRNA vaccine in ballpark.

Okay. I see. Thank you. That makes sense. 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 (President and CEO)

Yeah, I'll take that. Thank you, Joey. We have our 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 2. I'll ask Douglas to give a little bit more detail.

Douglas Faller (CMO)

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. 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. By keeping this very, very similar to OVATION 2 in nearly every respect except size, this gives us the best chance of reproducing and even strengthening the results we got in OVATION 2.

Similar population of patients, a 500-patient study as opposed to 112 patients in OVATION 2. 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. As a 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 a lot more sense. Thanks for answering my questions. Really appreciate it.

Stacy Lindborg (President and CEO)

Thank you, Joey.

Operator (participant)

The next question comes from David Bautz with Zacks Small-Cap Research. Please go ahead.

David Bautz (Senior Analyst)

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? What could potentially lead to the possibility for an accelerated approval?

Stacy Lindborg (President and CEO)

David, thank you for the question. I'm pleased you're on the call. I would say that the thought behind my prepared remarks is really just reflecting on the evidence that's emerging. As you know, we released updated overall survival data after seven months after we read out 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 0.06. 0.06, yes.

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

Douglas Faller (CMO)

I'd just add that one of the major criteria, as I'm sure you know that the FDA has recently enforced, is that a phase three confirmatory trial be underway when considerations for accelerated approvals off the basis of a smaller study are considered. 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 three confirmatory study is underway. It will be a convergence of a number of events which would allow us to be in a good position at that time.

David Bautz (Senior Analyst)

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

Douglas Faller (CMO)

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

Stacy Lindborg (President and CEO)

That's right. The protocol, we haven't talked a lot about it, but it has some very exciting components to it. 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 is a very, very consistent group. 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. 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. This trial design is very strong in that manner.

David Bautz (Senior Analyst)

Okay. 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 describing, then that's possible. Am I understanding that correctly?

Stacy Lindborg (President and CEO)

Yeah. 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 that is a seamless transition if we choose to revert to an initial target of HR deficiency. We will be well-positioned, and we 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 (Senior Analyst)

Okay. Yeah. Sounds great. Thanks for taking my questions.

Operator (participant)

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

James Molloy (Managing Director and Senior Equity Analyst)

Hey, guys. Thanks for taking my questions. What are your—can you characterize how the partnership environment looks currently, sort of versus vis-à-vis a potential fundraise? Given the impending cash crunch here, you guys talked about second quarter of this year. How is that impacting any potential partnership discussions?

Stacy Lindborg (President and CEO)

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 of a financing that are still in discussions with us. I think we all appreciate this is a very tough market. It's not just for Imunon, but virtually all microcap 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 FDA in our plans to move into Phase 3. With these in mind, if we're patient, I believe we will find the appropriate investors to proceed with the trial.

James Molloy (Managing Director and Senior Equity Analyst)

Sort of following up on that, how has the anti-vaccine sentiment in the recent administration impacted any potential for PlaCCine and partnerships there? It's been a strange change, to be sure.

Stacy Lindborg (President and CEO)

Yeah. James, there is a lot that's evolving. I would say that we have impressive data. It's early. The data that we're reporting was recently received. We're just starting to explore it, and as we make progress, we'll provide timely updates. 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 Faller (CMO)

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?

Stacy Lindborg (President and CEO)

That's exactly right. 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. Khursheed, I don't know if you want to add anything to the discussion.

Khursheed Anwer (EVP and Chief Science Officer)

No, no. I think very valuable feedback on that question. Clearly, as Douglas Faller said, the application to infectious disease may be, as James mentioned, about government position. Cancer vaccine is certainly an important application and raising benefits of being published. We will be sharing ACR data.

We're using a mouse model of cancer where we did target some specific antigens of tumor in a way parallel to the personalized cancer vaccines, and we demonstrate immune response activation and benefit in survival. That is clearly, as Dr. Faller said and Dr. Lindborg, that that is an application venue that you can branch into if there are certain government-level things that are not in our control. That is an application that's getting a lot of credence in the literature. We have shown that our approach works, at least in the animal models to start with.

Stacy Lindborg (President and CEO)

I just wanted to add one last comment.

Khursheed Anwer (EVP and Chief Science Officer)

Yep.

Stacy Lindborg (President and CEO)

On this front, James, before you go forward, we've demonstrated proof of concept. This was our target and our goal. I do want to be clear that PlaCCine is not our priority within the company.

We are focused on IL-12 and our Phase 3 study and TheraPlas. It is important that we pursue and use the strength, PlaCCine as a derivative, I think, as you know, of our TheraPlas 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 in non-dilutive funding. We'll give you updates as we make progress.

James Molloy (Managing Director and Senior Equity Analyst)

Thanks. Maybe a final question for Dr. Faller. 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, "This is the time to be joining Imunon"?

Douglas Faller (CMO)

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 front line 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. 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 shows 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 is well tolerable. The FDA had no safety concerns. How often do you hear the FDA say that? This is a straightforward path to getting this drug to patients.

James Molloy (Managing Director and Senior Equity Analyst)

Thank you for taking the questions.

Stacy Lindborg (President and CEO)

Thanks, James.

Operator (participant)

The next question comes from Jason Kolbert with D. Boral Capital. Please go ahead. Jason, maybe you're up.

Jason Kolbert (Head of Research)

Hi. Can you hear me? Yes, we can hear you. Okay. Great. 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 (President and CEO)

Yeah. Great question, Jason. We worked with a really very well-known group called Berry Consultants. The founder is on faculty at MD Anderson. They have played a really prominent role in oncology as well as really innovative designs. We worked with them on this design to allow 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. That was a very important part of the design, which did include a lot of clinical trial simulations.

You want a really good statistician 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 has continued to improve to strengthen OVATION 2. We started with the intent to treat the initial readout. 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. We brought in slightly more pessimistic assumptions, knowing that we had a trial set up where if, in fact, it was stronger, then we were assuming we would hit on an early interim.

What we know based on the trial design is that with these realistic, I think, assumptions and all of our simulations and the effects that were studied would be strong advancements for the medical community, right? 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. The power of our trial right now on the intent-to-treat population is about 95%, and in the HRD population is higher than that. We have a very well-powered trial, a trial that allows for early readout if there is warranted, in fact, in both HRD population and intent-to-treat population, and then a final readout if the interims do not yet warrant stopping.

Jason Kolbert (Head of Research)

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 (President and CEO)

We, 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. Through Douglas, we have a proven track record of running trials in really difficult-to-recruit populations. I would say that we balance not only our own insight 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.

I do think we're confident in our ability to meet the enrollment that we're setting. 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. We're going at this pragmatic, and I think based on our experience. Douglas, I don't know if you have anything you want to add.

Douglas Faller (CMO)

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

Jason Kolbert (Head of Research)

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? Maybe that's not an issue at all. If you could just talk about that a little bit.

Douglas Faller (CMO)

The points you make are really extremely important. 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 do not have the kind of toxicities that one sees delivering it systemically or even locally. This is the technology that, as Stacy has mentioned, allows us to treat these patients.

Room for improvement, room for new innovation, that's certainly something we're interested in. 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. Stacy, can you add?

Stacy Lindborg (President and CEO)

Yeah.

Khursheed Anwer (EVP and Chief Science Officer)

Please. This is a gene—Jason, this is a gene therapy product. A classical small molecule is a protein. You inject, and they have a clearance kinetics. Here, the cells take up the material, the DNA, and then express it for a long period of time. That adds to the durability of the drug. Clearly, like with any drug, improvement can be made. Polyethylene glycol is part of this delivery system that enhances the residence time of the nanoparticles that can be further enhanced. The second step is the expression from the cell that's durable too. It is a different type of biologics compared to the small molecules in terms of durability.

Jason Kolbert (Head of Research)

Yeah. That is exactly where I was going. Thank you. I appreciate that. I am sure you are always looking at ways to kind of dial that in a little tighter. Thank you.

Khursheed Anwer (EVP and Chief Science Officer)

Absolutely.

Stacy Lindborg (President and CEO)

Jason, one thing I want to add just for context, we have to keep in mind that when we are successful, right? I will talk 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. We will be moving forward progress, and I expect we will 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, as our CSO, who is the founder of this technology, we have great depth and strength within the company. 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 we and when we get to that place. That is a very important perspective.

Jason Kolbert (Head of Research)

Yeah. I'm excited for patients. Thank you.

Stacy Lindborg (President and CEO)

Thank you, Jason.

Operator (participant)

Thank you. Again, if you have a question, please press star then one. Our next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead.

Kemp Dolliver (Director of Research and Senior Analyst)

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

Stacy Lindborg (President and CEO)

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 trial support across the board was suffering, that they have now been able to reengage. This is about engaging very well-established sites and getting them up and running. We have had MD Anderson as the lead site, Dr. Amir Jazaeri that has delivered extremely well at his site, and now others coming on board. Our goal is to enroll 35 patients this year. That's our corporate goal for the study, and that would really be getting us to the point of completing the trial. We see that as extremely as a goal that we will accomplish.

It's the goal we've set for ourselves. I guess the last point I would add is that I do think that the updated data from OVATION 2 also gives a lot of strength when we have calls with our RPIs. 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 Faller (CMO)

If I can also mention that our recruitment rate has picked up. In addition, as the sites have opened, slow site openings have plagued clinical trials ever since the pandemic, as I think you know. 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. There have been no safety issues.

Kemp Dolliver (Director of Research and Senior Analyst)

Good. Stacey, 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?

Stacy Lindborg (President and CEO)

50. That is correct. That is correct. That would get us basically to the end of the enrollment period.

Kemp Dolliver (Director of Research and Senior Analyst)

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 12 months that I think you have planned?

Stacy Lindborg (President and CEO)

I might answer your question in another way. 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 our consultant at Harvard that is so well-versed in the vaccine space and COVID-19—effectively, our entire population, he would say based on his publications, Dr. Barouch, 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.

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 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. That's been the topic of our conversation. 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 (EVP and Chief Science Officer)

Yeah. Just to reiterate what exactly Stacy said, I think we were pleased to see that there's immunogenicity of DNA vaccines. As you know, DNA vaccines have not been very effective unless you use a device, electroporation or a jet injection device. We accomplished that with a simple needle injection method. That is the first thing, that the DNA vaccine is immunogenic and safe. This was done in SARS-CoV-2 system, which is, as Stacy mentioned, prior infection, prior multiple vaccinations. Not the best system. Certainly, durability-wise, in animal models where you had naive animals, we have seen longer duration on protection also. It just sets the program now for this proof of concept of immunogenicity demonstration in humans and faith to really expand this into other applications where you could really further follow for durability also in a model that would be not this messy in terms of prior vaccination infection.

I think that would be a real assessment of the technology of what we find in the animal models in terms of durability would be in a different disease to go after after this POC. Thank you.

Douglas Faller (CMO)

Thank you.

Stacy Lindborg (President and CEO)

Thanks, Kemp.

Operator (participant)

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 (President and CEO)

I want to thank everybody for the questions and really the engaging discussion that we had. 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 treatment in ovarian cancer. We chose to focus on the most significant challenge facing these patients.

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 disruptive 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. I look forward to keeping you appraised of our progress. Thank you for joining us today and for your interest in Imunon. Have a great day, everybody.

Operator (participant)

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