Q3 2025 Imunon Inc Earnings Call & Business Update

Speaker #1: Good morning. My name is Myron Fernandez, and I will be your operator today. At this time, I would like to welcome you all to Imminent Thirds Quarter Financial Results Conference Call.

Speaker #1: All lines have been placed on mute to prevent any background noise. Following the speakers' prepared remarks, there'll be a question-and-answer session. You may press star and one on your phone to ask a question at that time.

Speaker #1: Please keep in mind, if you're using a speakerphone, you must release your mute function to allow the signal to reach our equipment. Again, that's star and one to ask a question during the QA session.

Speaker #1: call over to Peter Vozzo I would now like to turn the from ICR Healthcare Investor Relations Representative for Imminent. Please go ahead.

Speaker #2: Thank you, Myron. Good morning, everyone, and welcome to Imminent's third quarter 2025 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Imminent's expectations and projections about future events.

Speaker #2: In general, forward-looking statements can be identified by the 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.

Speaker #2: 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 this live broadcast, November 13, 2025.

Speaker #2: Imminent undertakes no obligation to revise or update comments made during this call, except as required by law. With that said, I would like to turn the call over to Dr. Stacy Lindborg, Imminent's President and Chief Executive Officer.

Speaker #2: officer. Stacy. Thank

Speaker #3: you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Faller, our chief medical officer and Ms. Kim Graper, our interim chief financial officer, who will be reviewing our financial results for the third quarter of 2025.

Speaker #3: Mr. Michael Tardugno, the executive chairman of our board, and Dr. Khursheed Anwar, our chief scientific officer, are also on the line and will be available for Q&A.

Speaker #3: We continue to make meaningful progress with our proprietary IL-12 immunotherapy Imminent 001. Through the Ovation 3 pivotal phase 3 trial for newly diagnosed advanced ovarian cancer.

Speaker #3: The urgency of this program remains front and center to our efforts to create value for shareholders and to address the unmet need of ovarian cancer which continues to claim far too many lives as the standard of care in the frontline setting has not advanced in over 30 years.

Speaker #3: Our Ovation 2 study demonstrated the first-ever overall survival benefit in a critical FDA endpoint in our randomized frontline trial. We are now laser-focused on confirming those unprecedented results in a well-regarded rigorous phase 3 trial.

Speaker #3: Three days ago, we hosted a highly successful R&D day in New York City at the Harvard Club, featuring renowned ovarian cancer opinion leaders, clinicians, statistical experts, alongside members of our leadership team.

Speaker #3: The event underscored the transformative potential of Imminent 001 for women with newly diagnosed advanced ovarian cancer. The investment community and those interested in advances in ovarian cancer treatment and women's health more broadly heard directly from investigators about the unmet need in this disease, affecting globally 300,000 new cases each year and claiming the lives of 13,000 women each year in the US alone.

Speaker #3: This is why Imminent 001's potential to deliver a 13-month median overall survival benefit in phase 2 with a hazard ratio as low as 0.42 in PARP maintained patients represents a potential paradigm shift.

Speaker #3: We have just come off a powerful series of presentations at the world's leading oncology and scientific forums, including ASCO, CITSE, ESMO, the AACR Ovarian Cancer Special Conference focused on advancements in ovarian cancer, and finally, IGCS.

Speaker #3: And the momentum is undeniable. Ovation 3 enrollment is surging ahead of plan, and this one-to-one randomized trial is evaluating Imminent 001 plus the standard of care neoadjuvant and adjuvant chemotherapy with interval debulking surgery, versus standard of care alone in women who have treatment naive advanced ovarian cancer.

Speaker #3: In July, we initiated a 500-patient all-comers trial of women with advanced ovarian cancer which has the flexibility to prioritize a 250-patient HRD-positive subgroup. This would enable us to realize a 40% cost savings with this prioritized group.

Speaker #3: The study design employs interim analyses for early efficacy stopping rules, demonstrating trial success with power above 95% on the clinically meaningful primary endpoint of overall survival.

Speaker #3: And as was discussed at R&D day, this analysis is accelerated over a traditional trial which would only read out the overall survival at the end of the study and success with these interim analyses is expected to deliver full approval, not accelerated approval.

Speaker #3: Key updates since our last call that I'll just quickly tick through. First, the site activation status of Ovation 3. We have been deliberate and consistent with our cash management responsibilities, which applies to our decisions around site activation.

Speaker #3: For sites that were initially activated in the U.S., we expect this number to double before the year's end, with four additional sites well progressed in startup activities.

Speaker #3: Returning investigators from Ovation 2 are being joined by additional top-tier centers many of which are proactively reaching out to Imminent following the recent publication of the Ovation 2 study results in the journal Gynecologic Oncology, which was published on the same day as the 2025 ASCO platform presentation.

Speaker #3: We also have inquiries about the trial from interested sites at other recent conferences. Furthermore, while we have moderated the activation of sites in 2025 to reflect our current cash position, we are preparing for a site activation surge.

Speaker #3: To this end, we have accelerated the to identify new study centers engagement of a global CRO for startup in the new year, and we estimate we will have all sites in the new trial activated before the end of 2026.

Speaker #3: Next, I'll comment on enrollment velocity. You know, the first patient in Ovation 3 was randomized and treated in July of this year, and we have seen strong investigators enthusiasm for the trial which has surpassed our internal enrollment target set for the end of 2025 with nine patients randomized by the end of October.

Speaker #3: I think you can all appreciate how important it is to have strong momentum at the start of the trial and we have started this trial with an impressive pace.

Speaker #3: Moving to regulatory and design validation, the FDA has endorsed overall survival as a single study registration endpoint, and based on precedent and European regulations, we expect Ovation 3 to meet regulatory expectations for approval in Europe.

Speaker #3: During our R&D day, Dr. Giorgio Polan, PhD in statistics with the company Berry Consultants, a highly regarded statistical consulting firm, highlighted this adaptive event-driven study design, a technique that is well aligned with precedented FDA approvals in oncology via interim analysis of overall survival.

Speaker #3: And he also highlighted the robust statistical foundation of our phase-through trial with conservative power estimates, yielding high estimates of probability of success of this trial.

Speaker #3: Let me just pause, and if you didn't have the opportunity to join our symposia live, I would encourage you to look on our website the Imminent.com website in the investor tab and under scientific presentations to watch it.

Speaker #3: We provide details of the power assumptions and it is remarkable to hear directly from these experts that were on the faculty that day. Lastly, new translational data and our MRD study.

Speaker #3: We had Dr. Amir Jazari from MD Anderson Cancer Center presenting at our R&D day. He's the lead PI for the ongoing phase 2 minimal residual disease, or MRD study, being conducted in collaboration with the Breakthrough Cancer Foundation.

Speaker #3: Dr. Jazari spoke to data collected so far in the trial demonstrating Imminent 001's preferential uptake by peritoneal macrophages. Including profound tumor microenvironment remodeling. Patients achieved complete pathological responses with durable intratumoral IL-12 and interferon gamma expression.

Speaker #3: All with negligible systemic exposure and excellent tolerability even as Imminent 001 in this trial is being administered with bevacizumab and treatment has continued in maintenance settings.

Speaker #3: Additional biomarker data which was presented at SITC last week by Dr. Fowler further confirmed T-cell and macrophage infiltration and immune activation that's predictive of superior prognosis.

Speaker #3: Dr. Primal Thacker from Washington University emphasized during the R&D day that Imminent 001 is able to turn what are immunologically cold ovarian tumors hot.

Speaker #3: By engaging both innate and adaptive immunity, renewing the promise of immunotherapy in this devastating disease. These mechanistic insights paired with unprecedented survival signal have fueled investigator commitments to accelerate enrollment.

Speaker #3: We estimate full enrollment in Ovation 3 will occur by late 2028, and I'll note that this can be accelerated with financing. I'll now turn over the call to Dr. Douglas Fowler for some clinical commentary, and comments.

Speaker #3: Douglas?

Speaker #2: Thank you, Stacy. As Stacy noted, our R&D Day on Monday in New York really crystallized the excitement we are seeing within the gynecologic oncology community regarding Imminent 001 and Ovation 3.

Speaker #2: Dr. Thacker's and Dr. Jazari's presentations followed by the rich discussion during the Q&A portion of events underscores the clinical importance of the data collected and reported in both Ovation 2 and in the MRD study in women treated with Imminent 001.

Speaker #2: Excuse me. As Stacy mentioned, over the last three months, we've been invited to present our Ovation 3 trial and the emerging translational data from Ovation 2 at four prestigious international scientific and clinical congresses.

Speaker #2: These include the ESMO 2025 in Berlin, the International Gynecologic Cancer Society meeting in Cape Town, the AACR Special Conference on Ovarian Cancer in Denver, and the Society for Immunological Therapy of Cancer, SITC International meeting in 2025 in Washington, DC.

Speaker #2: These global forums gave us the opportunity to interact with both scientists and clinicians. After our presentations, a number of clinical investigators, impressed by our novel therapy and the patient benefit realized in Ovation 2, approached me asking if their hospital could participate in the Ovation 3 trial.

Speaker #2: Similarly, scientists intrigued by the demonstration in patients that Imminent 001 turns immunologically cold tumors into hot tumors anti-tumor activity asked about the possibility of collaborating with us.

Speaker #2: Interestingly, at the SITC meeting several days ago, several participants noted the renewed interest in harnessing the powerful anti-tumor effects of interleukin 12 as evidenced by at least 15 interleukin 12 related presentations.

Speaker #2: However, they also noted that, with the exception of ours, these presentations were focused on their early attempts to formulate or deliver interleukin-12 so as to avoid the well-known systemic toxicities.

Speaker #2: These attempts include intratumoral injection, which is not a long-term strategy. All of these efforts were preclinical or early phase 1. In contrast, Imminent, as you know, as a pivotal phase 3 registrational trial, Ovation 3 actively recruiting.

Speaker #2: This Ovation 3 trial has been fully leveraging the excitement of IL-12 as a cancer therapeutic and the remarkable Ovation 2 clinical outcomes. As Stacy mentioned, study startup, as defined by protocol approval, was achieved in 15 weeks—nearly half of what is typically seen as the industry standard for Phase 3 trials.

Speaker #2: As we engage with our first set of study centers, we continue to see great interest and enthusiasm from our investigators, with the early sites so far activated far exceeding monthly estimates of the number of patients enrolled per site per month.

Speaker #2: Ovation 3 is still in its early stages, but we're observing clean, safety run-in data from the first patients. Meanwhile, the ongoing phase 2 MRD study as Stacy mentioned continues to reinforce Imminent 001's favorable profile.

Speaker #2: Giving us real-time confidence as we scale the pivotal trial. Following a recent MRD study DSMB meeting, we're pleased to share that the benefit-risk profile of Imminent 001 has been further strengthened in this MRD study and mirrors what we have seen in Ovation 2.

Speaker #2: No dose-limiting toxicities, no discontinuations due to Imminent 001, and no elevations in immune-related adverse

Speaker #1: of progression free Ability survival on the arm . A lower positivity rate and a lower percentage of MRD biopsies . Positive during in second look MRD the , patients .

Speaker #1: Lastly , the MRD studies demonstration of the feasibility and safety of combining immunology with bevacizumab and the preliminary view into the idea of Imunon, Inc. 001 as maintenance positions .

Speaker #1: Zero zero one uniquely for future trials and possible label extensions . me , that could Excuse contribute even further to the fight against this terrible cancer .

Speaker #1: Back to you , Stacey .

Speaker #2: Thanks , Douglas . Before turning to our financial update , I'd like to offer and really highlight further progress in advancing our MRD share an update trial and .

Speaker #2: First , notably , the breakthrough Cancer Foundation selected this trial for from funding hundreds of competing proposals , which a is very strong that endorsement echos doctor remarks at our Gary's R&D day of the importance of frontline therapy as the best opportunity to cure for ovarian achieve a cancer .

Speaker #2: based on the preliminary clinical And data from the trial that Douglas just we reviewed , are thrilled with the consistency of immuno 001 effect compared to our two clinical results We've .

Speaker #2: great made progress in the of the enrollment MRD trial , with three patients being randomized and treated in the month of , resulting in October a total of 25 patients randomized to date .

Speaker #2: on this Based progress in September , we reviewed the MRD study and confirmed that its core objectives , which include those that we have for the internally immuno oh one development and break through plan cancers goals , as well .

Speaker #2: These objectives can core be fully met with a smaller cohort of patients . cap Accordingly , we enrollment decided to at 30 patients in the intent to treat population , a milestone that we expect to reach in the first 2026 .

Speaker #2: We will be thrilled to close out trial and this of capture its full learnings , enabling us to channel our resources into the pivotal ovation three phase three trial .

Speaker #2: fact , In I'll mention that we've already begun conversations with the success in mind . We've started conversations with MRD investigators about transitioning their sites to ovation three .

Speaker #2: At that time , a move that would further accelerate enrollment in our registration trial . And I'll note that we've received positive reactions to these inquiries .

Speaker #2: Turning to our financial strategy , we continue to navigate a challenging biotech capital markets environment with discipline and foresight . Our multi-pronged approach , combining the potential for non-dilutive partnerships with prudent equity , raises opportunistic use of our ATM facility .

Speaker #2: Remain on plan , and we've made significant progress . Shareholder dilution is a valid concern and we it share . That's why every financing decision is stress test against our commitment to preserve value .

Speaker #2: While actively working to fully fund this pivotal program . We have ongoing reviews for potential partnerships with therapists and interest expressed by pharmaceutical companies on placein from a recent scientific meeting , but nothing that is imminent .

Speaker #2: These kinds of partnerships take time to build , and I look forward to providing more detail if we advance these discussions to terms on the equity side , we've 4.5 million raised during the third quarter through warrant exercises and targeted ATM usage .

Speaker #2: Monthly cash burn is now approximately 1.25 to 1.5 million . Reflecting streamlined G&A expenses . Renegotiated facility leases and a laser focus on advancing immune on 001 milestones Furthermore , .

Speaker #2: operating expenses for nine months ended September 30th between 2025 , compared to 2024 is 31% lower , which includes 44% decrease in R&D expenses and a 52% decrease in CMC expenses .

Speaker #2: And mind you , is all while manufacturing product for phase three conducting CMC development work and preparation for reduced cost of products sold in the commercial landscape and accelerating site patient activation with cash through mid 2026 and Q1 multiple near-term catalysts such as enrollment momentum , regular presentations at medical and scientific congresses , and the potential for partnership progress .

Speaker #2: We are well poised to extend our runway further , ideally through enhancing value non-dilutive transactions . A few other note , updates of the Nasdaq Compliance matter is closed .

Speaker #2: We achieved the dollar minimum bid price requirement on August 9th . We sustained shareholder equity above the 2.5 million confirmed on August 22nd .

Speaker #2: In fact , we're far above this matter was also . formally This closed by Nasdaq on September 3rd , 2025 . And I'm delighted to report that , as reported in the current and we are at 4.1 in the shareholder equity threshold .

Speaker #2: Now , I'll turn over to Ken for our review of the third quarter 2025 results . Thank you . Stacy . Detail of third quarter 2025 financial results are included in the press release .

Speaker #2: We issued this morning .

Speaker #3: in our And form 10-q , which we filed before the market opened this morning . As of September 30th , 2025 , cash and cash equivalents were $5.3 million .

Speaker #3: During the third quarter , company received the approximately $4.5 million of net proceeds from the exercise of warrants and sales . Under our ATM equity facility .

Speaker #3: The ATM facility carries a nominal 3% fee with no warrant . We project that this . Balance our extends operating roadway into mid quarter .

Speaker #3: First quarter of 2026 . R&D expenses were $1.9 million for Q3 2025 , down from 3.3 million in the same period last year , primarily due to completion of the ovation two study and lower costs associated with the phase one vaccine .

Speaker #3: vaccine DNA trial and development costs for the vaccine . DNA vaccine technology platform G&A expenses were $1.6 million in Q3 2025 , down from 1.7 million in the same period last year , due to lower employee related legal and travel expenses .

Speaker #3: Net loss for Q3 2025 was $3.4 million , or $1.16 per share , compared to $4.8 million , or $3.76 per share , in the third quarter of 2020 .

Speaker #3: For please note that all shares and per share amounts have been adjusted to reflect a 15 for one reverse stock split of our common stock , which we effected on July 25th , 2025 , and the 15% stock dividend was in the quarter .

Speaker #3: With that , the Financial Review , I'll turn the call back to Stacy .

Speaker #2: Thank you . Kim . Before we open the line for questions , I want to reflect on the questions we received through the webcast .

Speaker #2: The live webcast at Monday's symposia , I was able to work the majority of these questions into my prepared remarks , with the exception of one question that I'd like to address as we kick off our Q&A .

Speaker #2: question This came from David Bouts through our tool . And I'll read the question . It looks like macrophages are the primary cell type that takes up immuno one .

Speaker #2: But how long do these cells continue to produce IL 12 ? on the presence Based of immuno , no one . Is there some type of feedback mechanism that Imunon, Inc. O one produces to prolong the production of IL 12 ?

Speaker #2: In these cells , after immuno one is metabolized , or is there an immuno 001 plasmid that encodes IL 12 long lasting is a very great question .

Speaker #2: I apologize , David , we didn't see it and weren't able to address it . Day of meeting , but the I'd like Khursheed Anwer to offer comments to this question .

Speaker #4: Stacy . Yeah , the it's a Sure , good question . Of course , the Unformulated plasmid , which is administered into the peritoneal cavity typically , you clears within 24 hours and may last a little longer if it is formulated with a delivery system such as that in immuno one , where the nanocomplexes have a protective effect on the DNA .

Speaker #4: However , once the plasmid is taken up by the cells of the peritoneal cavity , such as macrophages or other immune cells or epithelial cells , it is internalized into the cell nucleus and can stay much longer , giving rise to long lasting up to several days .

Speaker #4: The levels of product , gene which is IL 12 , in the case of immune one . So yes , it is indeed the plasmid inside the cell that lasts longer , giving rise to the pharmacokinetic that we have seen with immune .

Speaker #4: Oh , of IL 12 and interferon gamma production .

Speaker #2: Thanks . I appreciate that . So , operator with that , please open the call for questions .

Speaker #5: Thank you . We will now begin the question and answer session . To join question queue , may press the star . And then one on your telephone keypad .

Speaker #5: You will hear a tone acknowledging your request . If you are using a speakerphone , please pick up your handset before pressing any keys .

Speaker #5: To withdraw your question , please press star and then two . We will pause for a moment as the callers join the queue .

Speaker #5: We have the first question from the line of David Boltz from Zacks . Please go ahead .

Speaker #6: Hey , good morning everyone . Stacy , I appreciate you answering that question that I had the other day . Sorry I wasn't able to ask it in person .

Speaker #6: There , but thank you for that response . There . I to start actually clear something up to make sure I understood . So you had mentioned that positive results in one of the interim efficacy in looking at the interim analysis would lead to a full approval .

Speaker #6: You now , is that a full think for all ovarian cancer patients , or would it be just for the HRD population ?

Speaker #2: Yeah . Clarifying that . And I , I think that when we were talking about the ability to accelerate the analyses through the use of an internal , you know , inter analysis , I wanted to make sure that people understood that that was the acceleration of getting to results .

Speaker #2: And if we are successful and we meet these statistical thresholds that are outlined and agreed to by the FDA , we would expect full approval in the group that we're testing .

Speaker #2: The trial is continuing in an all comers population . Then at the end of the trial , that would allow a broader label indication .

Speaker #2: So but I think it is really important to understand we're really reflecting the devastation of this disease and the need as we saw .

Speaker #2: We know that we're also making rather conservative assumptions , power assumptions . So it's very possible . In fact , Giorgio spoke to the , you know , the likelihood of being successful at one of the two interim analyses .

Speaker #2: We want that urgency to be very clear. We want to be able to move forward rapidly with a BLA filing based on that data, and then to be able to allow for the product to be approved in that indication.

Speaker #2: And accessible to patients . But it allow the would trial to continue to to the end and and to have , you know , to them potentially expand the to to the all comers population .

Speaker #6: Okay . Thanks . That makes sense . Kind of keeping along the same theme . What what p value . Or can you say what p value needs to be hit at either the first or second interim order to be able to stop the analysis in ?

Speaker #6: If it's efficacious ?

Speaker #2: Yeah , it's it's unfortunately it's a little more complicated than just a raw p value because and this is where Giorgio did a really great job of really highlighting the simulation results .

Speaker #2: They set complex operating characteristics that ultimately are needing to take into account kind of an information fraction of where you are in the trial .

Speaker #2: And therefore appropriately control type one error rates . So the the logistics of it are very well documented . And there was a very large report that was submitted to the FDA that these simulations really documented proper control , the type one error rate .

Speaker #2: And then all of the operating characteristics of the FDA would be keen to understand. So it's not just a fixed p-value.

Speaker #2: if And you , you know , are interested in more , we we can can have a perhaps another another conversation on it .

Speaker #2: But it is it's very well laid out based on , you know , where this would occur . And because the , you know , when in the point of the trial , when the 50th HRD event , which is the the trigger for the first interim would occur , that's not a fixed point in time .

Speaker #2: It's an unknown will evolve . And that then that will affect , these these you know , thresholds .

Speaker #6: . Understood Okay . Yeah . And then lastly , I believe it was doctors Staker had talked about pain management for when I am an oh one is administered and kind of how that pain management has evolved basically with her experience with the I'm just curious , is there drug .

Speaker #6: A set protocol in place for management at all the different clinical sites, or is it kind of up to the clinician's discretion?

Speaker #2: That is

Speaker #2: a really great Douglas . Do you question , want to . take . that ?

Speaker #1: happy Be to . And thank you for asking the question , because obviously , patient comfort and is critical for us and for the of ability to patients get the drug in patients who have ovarian cancer in the peritoneal space , they are often quite tender because of the inflammation that's there before drugs start to work .

Speaker #1: happy Be to . And thank you for asking the question , because obviously , patient comfort and is critical for us and for the of ability to patients get the drug in patients who have ovarian cancer in the peritoneal space , they are often quite tender because of the inflammation that's there before drugs start to the infusing anything into the And space can cause discomfort for This happened in patients .

Speaker #1: some patients in ovation two , and the physicians in combination with , decided immune that rather than waiting for this to occur , that we could prophylactically treat patients , give them some analgesia prior to the infusions , prior to even the first infusion .

Speaker #1: And if there were going to be any discomfort , this would alleviate it . If it turns out it's not necessary later on , that could be stopped for individual patients , it's been quite useful , quite We're successful .

Speaker #1: not seeing this . Was this . And it's a to answer your more question fully , this is part of the protocol . So this is mandated for all patients .

Speaker #1: This was also incorporated into the MRD study . And we have data from Doctor Jaziri sites that he's managing that this has been very successful .

Speaker #1: They've not had problems with any sort of abdominal discomfort in patients, and so far in Ovation Three, we've not seen that either.

Speaker #1: So the prophylaxis for potential discomfort with the infusion seems to be working very well.

Speaker #6: Okay. Great. I appreciate that. And thanks for taking the questions.

Speaker #7: Good .

Speaker #5: Thank you . We have the next question from the line of James Malloy from Alliance Global Partners . Please go ahead .

Speaker #8: Hey good Thank you very morning . taking my questions . I had a much for question , Doctor Fowler . One of the things you talked about on the on the R&D about the day was durability of response , you know , sort of speaking to the mechanism of action , of triggering the immune system and some of the IL 12 expression in the fluid and tissues .

Speaker #8: Can you walk us through that a little bit , please ?

Speaker #1: happy Very to . And please stop me if I'm telling something you you already know and not it's not appropriate to your question .

Speaker #1: So we're the problem with IL 12 delivered systemically , as you know , has been not tolerable . it's simply It's too potent .

Speaker #1: Like IL two . You can't give it at high enough doses systemically . Let's say intravenously , because of it's hard to call it toxicity .

Speaker #1: Let's call it adverse events . I don't call it toxicity because it is actually the intended activity of the cytokine . But patients have just like IL two patients with third space , a lot of fluid into outside of the vascular system , low blood pressures , fevers , etc.

Speaker #1: so , that's prevented IL two , IL 12 , excuse me , and IL two from being used effectively . Here . We're delivering the drug where the tumor is into the intraperitoneal space .

Speaker #1: That's where the ovarian cancer has spread in all the patients that we're treating . And so as Khursheed mentioned earlier , this is a gene therapy .

Speaker #1: The plasmid gets taken up by the tumor cells and also by the tumor microenvironment cells . The stromal cells and express IL 12 .

Speaker #1: It's expressed, and IL-12 then induces interferon gamma and TNF-alpha, which are incredibly potent immune effectors that stimulate both the adaptive and the innate immune systems.

Speaker #1: The IL 12 levels in the peritoneal fluid . We've reported in interleukin . Excuse me , innovation innovation one and two logs . There's tremendous amount of 12 and its IL downstream effector cytokines expressed in the intraperitoneal fluid .

Speaker #1: And in the tissues , as you would expect in the peritoneum . However , in one and ovation innovation two , we've monitored IL 12 levels systemically and we don't see increases in IL 12 systemically , no more than twofold .

Speaker #1: This is the basis for the remarkable safety we have. We're not seeing the kind of adverse immune events that everyone else who tries to deliver the drug systemically has seen.

Speaker #1: We're not seeing any cytokine release syndrome kind of events , which completely goes along with the fact that we're not elevating IL 12 or its effectors cytokines , systemically .

Speaker #1: It's just where the tumor is in the intraperitoneal space . The durability . Khurshid already addressed the the amount of time that plasmid is the expressed .

Speaker #1: We can see IL 12 levels in the peritoneal fluid for at a week after a least single injection , and we give the drug weekly , at least during the patient chemotherapy .

Speaker #1: We can see IL 12 levels in the peritoneal fluid for at a week after a least single injection , and we give the drug weekly , at least during the patient is getting response is when I was pointing to the slides was just showing that we give drug during the chemotherapy , which is six cycles essentially , plus a surgery debulking at the beginning of treatment for the patients .

Speaker #1: Yet we're seeing effects years later . We're seeing the curve separate . We're seeing a benefit for survival in patients . And this is long after we've stopped giving the drug .

Speaker #1: This is consistent with what you would like what to see , you'd expect to an effective immune therapy . Once you've educated the immune system to kill the tumor , that should You should persist .

Speaker #1: not necessarily have to keep stimulating . Although in the MRD study , we are exploring maintenance therapy to see if that would add additional benefit .

Speaker #8: Well , great . Thank you for that . And one of the things that that Stacy had mentioned , I think , as well as talking about the ovation three meeting , the regulatory approval for the EU , any details on that process and maybe also , you know , you mentioned , Stacy , that , you know , obviously you're constrained by the amount of cash you have to run the trial .

Speaker #8: If you had more cash to run it quicker, if you had unlimited funds, quickly could you run this trial? How?

Speaker #1: maybe I Stacy , could address , if you don't mind , the regulatory issues , and then you can talk about the financial ones .

Speaker #2: Please go ahead .

Speaker #1: Okay . So the issues in Europe are twofold , as I'm sure you know . One is getting the trial . Excuse me , is getting the drug approved by the EMA , but equally important is getting payers to actually agree to support use of the drug in Europe .

Speaker #1: What payers want to see in cancer is survival is . PFS not something that traditionally , in my experience , payers are willing to pay for .

Speaker #1: So our endpoint is overall survival . So we've already ticked the box that the payers would want to see the study is designed in a way that should be completely acceptable to EMA the .

Speaker #1: I've had a lot of experience in dealing with the EMA and many other regulatory agencies outside of the US , and we could open studies in Europe .

Speaker #1: It's not necessary for European approval , but let me turn it over to Stacy . Now , with respect to what we'd like to do with adequate funding .

Speaker #2: Yeah . Interesting question . And I can tell you that , you know , when you think about some of the remarks that Douglas that provided , really characterize how quickly we're moving , I can promise you , to be we're going focused on advancing trial and taking advantage of every opportunity that we can .

Speaker #2: And so , you know , we've done a number of different , you know , kind of internal forecasts . As I shared before , right now , you know , our estimate is that we'll be able to fully enroll this trial in about three years .

Speaker #2: I , we have done a forecast that is as quick as two years . I think that is something that we . plans Put behind to consider how we would achieve it .

Speaker #2: And believe we that it is possible . Beyond that , you know , I really wouldn't want to to go too much further .

Speaker #2: There are ways that you could actually pull it in , even even further . But I think it gives you an idea of way that of the we're we're looking at this and ensuring that we will be ready and able to accelerate very quickly .

Speaker #2: Some of these proactive approaches with our the CRO that we're working with , that , interestingly enough and importantly , don't change the overall price that we to expect pay , including even pay the CRO .

Speaker #2: We're just advancing activities so that we'll be poised and we can actually see the site when we activations want them , rather than waiting to engage them .

Speaker #2: At that time . So those are those are some of the operational strategies .

Speaker #8: Thank you very much for taking the questions .

Speaker #2: Thank you .

Speaker #5: Thank you . We have the next question from the line of Emily Bodnar from H.C. Wainwright . Please go ahead .

Speaker #9: Hi . Thanks for taking the questions . First one , I'm curious of your planning to share an update from the ovation two trial , particularly the Parp inhibitor treated patients in terms of median OS in the last update , it was not reached yet , and if so , when you might expect to do that .

Speaker #9: And then second question how many sites for the ovation three trial are you expecting to be sites that part were of ovation two , and are those the sites that you're kind of targeting initially ?

Speaker #9: Thank you .

Speaker #2: Yeah . Emily , thanks for both of those questions . Let me take a stab at both . And then if there are other points , Douglas , you could maybe add on in terms of ovation two .

Speaker #2: So you know , in our protocol stated we that we would monitor overall survival . We you know , designated the the period of time that we would continue to monitor it .

Speaker #2: And it really puts us in a place where we're starting to wind down sites . We expect by the end of the year that we'll have the data fully refreshed and the sites that will be closing .

Speaker #2: And I think at the end of the day , you know , when you look at at this trial , we know that the data that we've collected , the , you know , even going to the first very interim across the all comers , the median was observed in both treatment arms .

Speaker #2: We know the data mature for very robust And so conclusions . I think I would say , you know , we shouldn't expect nor would the medical community expect to see significant changes .

Speaker #2: You know , to these results . But we will we will have likely have this process really finalizing towards the the year end of and early next year .

Speaker #2: don't know if you have Douglas , I any kind of you already commented on the reflection of how long we're seeing this effect past the treatment period , but when we ultimately look at the size of separation and , you know , at R&D day , we we looked at some of the graphs that have come out of recent these immune checkpoint inhibitors , where you see really no separation .

Speaker #2: Tell me your reflection as a clinician on the time periods when we were observing and did these two readouts really were these appropriate in terms of when you would be expecting , you know , these these the separation , the phase of the curve to really be , well estimated .

Speaker #1: Certainly . And you've actually already spoken to it , Stacy , the primary innovation to the endpoint is medians . Well , a secondary endpoint was median survival in the entire population .

Speaker #1: And that's when we our initial readout , we achieved that information in trials in Once you've gotten median cancer . survival in your primary population longer observations , you know , less and less I information .

Speaker #1: I think curves with fewer patients on them start to become less informative. So we're very eager to be seeing the effects over time that we've seen.

Speaker #1: I think that the the concept of using this drug in the neoadjuvant setting is really was a remarkably smart choice early on in its development .

Speaker #1: So that the and this became a big of great interest at Asco using immunologically immunologically active neoadjuvant drugs in the setting where there's still tumor there allows the immune system to be educated in the setting of the tumor , using it later in an adjuvant setting , when there's little or no tumor , there , drugs like even like checkpoint inhibitors , as was being realized at Asco , are much less effective .

Speaker #1: So I don't I don't have anything beyond that to say . Stacy .

Speaker #10: Thank you . .

Speaker #2: Emily , your second question was about the sites from ovation two . And maybe even I don't know if getting at you were the overlap or total number of the innovation .

Speaker #2: Three , but we will have great overlap . Innovation two . Innovation three . Not we surprisingly , started , you know , sites with that were very strong in rollers , very enthusiastic about the trial .

Speaker #2: We see that certainly extending to many other sites from ovation to . But we will have new sites simply because we are planning to have up to 50 , 50 sites .

Speaker #2: And , you know , we'll ultimately look at the number that we of sites need to stay really with our forecast and keep enrollment going .

Speaker #2: And then we'll plan accordingly . We have flexibility in the way the protocol is written that we can go higher if we decide we want to do so , but , you know , it's a it's a careful , you know , you have to carefully manage not bringing in too many sites , really keeping your sites that performing extremely well and , you know , the enthusiasm these , of these early sites .

Speaker #2: And I would say, really, the sites from to not ovation only from their knowledge of the product. You heard Dr. Thacher at R&D day actually comment on the fact that she's been working on one for almost a decade.

Speaker #2: So she was involved in ovation , one , ovation two . Now is again , the the Pi for ovation three . You they're there confidence and what's conviction in happening in these women which of course they see when they're doing surgery .

Speaker #2: They observe as they're meeting with them for years after enrollment . And the trials . It's palpable , right ? It's incredibly clear they they believe very much that this is the potential for this product to be transformative .

Speaker #2: care To is is great . So , you know , it's really wonderful to see these these clinicians that are also offering up to meet with new sites .

Speaker #2: They're very willing to offer perspective on the ways that they've managed , you know , every trial has new aspects that sites have to really get comfortable with .

Speaker #2: And they're very willing to share operational updates as well as really talk about data and what they've observed in patients over time . So it's it really is kind of the best of both worlds .

Speaker #9: Thanks for taking the questions .

Speaker #2: Thank you .

Speaker #7: Emily .

Speaker #5: Thank you ladies and gentlemen . That concludes the question answer session for today . I will now turn the call back over to Doctor Lindberg for closing remarks .

Speaker #2: And Thank you . thanks to everybody for joining the call with ovation three enrolling ahead of plan . We've talked about the compelling clinical and translational data from R&D , R&D day and and also recent conferences , CSI .

Speaker #2: Just last week and active partnership discussions . Imunon, Inc. poised for multiple value inflecting milestones . We remain diligent in stewarding the resources you provided .

Speaker #2: As I hope you're able to see very clearly in the Q and are steadfast in our mission to redefine ovarian cancer treatment and deliver lasting shareholder value.

Speaker #2: So thank you all for your support, and I look forward to meeting again at the next quarterly earnings.

Speaker #5: Thank you . Ladies and gentlemen . That concludes today's conference . Thank you for participating . And you may now disconnect your lines .