Imunon, Inc.

Good morning. My name is Myron Fernandes 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. 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 and 1 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 and one to ask a question during the Q&A session. I would now like to turn the call over to Peter Wozo from ICR Healthcare Investor Relations Representative for Immune. Please go ahead.

Thank you, Myron. Good morning, everyone, and welcome to Immunize Third Quarter 2025 Financial Results and Business Update Conference Call. During today's call, management will be making forward-looking statements regarding Immunize expectations and projections about future events. 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. 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 13th, 2025. Immunon undertakes no obligation to revise or update comments made during this call, except by required by law. With that said, I would like to turn the call over to Dr. Stacey Lindborg, Immunon's President and Chief Executive Officer. Stacey?

Thank you, Peter, and good morning, everyone. Joining me on the call this morning is Dr. Douglas Fowler, 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. Mr. Michael Tardigno, the executive chairman of our board, and Dr. Khurshid Anwar, our chief scientific officer, are also on the line and will be available for Q&A. We continue to make meaningful progress with our proprietary IL-12 immunotherapy, Immunon 001, through the Ovation 3 Pivotal Phase 3 trial for newly diagnosed advanced ovarian cancer. 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. 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 regressed phase three trial. 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. The event underscored the transformative potential of Immunon 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 U.S. alone. This is why Immunon-001's potential to deliver a 13-month median overall survival benefit in phase two with a hazard ratio as low as 0.42 in PARP-maintained patients represents a potential paradigm shift. We've just come off a powerful series of presentations at the world's leading oncology and scientific forums, including ASCO, CITC, ESMO, the AACR Ovarian Cancer Special Conference focused on advancements in ovarian cancer, and finally IGCS. And the momentum is undeniable. Ovation 3 enrollment is surging ahead of plan, and this one-to-one randomized trial is evaluating Immunon 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. 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. 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. 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. 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. Four sites were initially activated in the U.S., and we expect this to double before year's end with four additional sites well-progressed in startup activities. Returning investigators from Ovation 2 are being joined by additional top-tier centers, many of which are proactively reaching out to Immunon 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. 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. To defend, we have accelerated the engagement of a global CRO to identify new study centers for startup in the new year. And we estimate we will have all sites in the new trial activated before the end of 2026. Next, I'll comment on enrollment velocity. You know, the first patient, Innovation 3, was randomized and treated in July of this year. And we have seen strong investigator 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. 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. 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. 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. 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. 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 iminon.com website in the investor tab and under scientific presentations to watch it. 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. had Dr. Amir Jazari from MD Anderson Cancer Center presenting at our R&D day. He's the lead PI for the Ongoing Phase II Minimal Residual Disease, or MRD study, being conducted in collaboration with the Breakthrough Cancer Foundation. Dr. Jazari spoke to data collected so far in the trial, demonstrating iminon-001's preferential uptake by peritoneal macrophages. including profound tumor microenvironment remodeling. Patients achieved complete pathological responses with durable intratumoral IL-12 and interfering gamma expression, all with negligible systemic exposure and excellent tolerability, even as immunon-001 in this trial is being administered with bevacizumab, and treatment has continued in maintenance settings. Additional biomarker data, which was presented at CITSE last week by Dr. Fowler, further confirmed T-cell and macrophage infiltration and immune activation that's predictive of superior prognosis. Dr. Pramil Thakkar from Washington University emphasized during the R&D day that Immunon-001 is able to turn what are immunologically cold ovarian tumors hot. 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. 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. Douglas?