Imunon, Inc.

Please stand by. Good morning. My name is Desiree and I will be your operator today. At this time, I would like to welcome you to Immunon's fourth quarter and full year 2025 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 1 on your phone to ask a question at this 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 1 to ask a question during the Q&A session. I would now like to turn the call over to Peter Vozzo of ICR Healthcare, Investor Relations Representative for Immunon. Please go ahead.

Thank you, Desiree. Good morning, everyone, and welcome to Immunon's fourth quarter and full year 2025 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Immunon's 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 those such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, March 31, 2026. Immunon 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. 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 Mr. Jeff Church, our Interim Chief Financial Officer, who likely needs no introduction, given his tenure with Immunon. He'll be walking through and reviewing our financial results for the fourth quarter and full year of 2025. Mr. Michael Tardigno, the executive chairman of our board, is also on the line and will be available for Q&A. We entered 2026 with strong momentum following a truly transformational year in 2025. Our proprietary IL-12 immunotherapy, Immunon-001, continues to demonstrate its potential to redefine frontline treatment for women with newly diagnosed advanced ovarian cancer based on all available data thus far, both translational and clinical. And Immuno-001 is rapidly advancing in the Ovation 3 Pivotal Phase 3 study. The urgency of this program remains front and center for our efforts to create value for our shareholders and to address the unmet need in ovarian cancer which continues to claim far too many lives as the standard of care, traditional chemotherapy in the frontline setting has not advanced in over 30 years. In our Ovation 2 study, Immuno01 demonstrated the first ever overall survival benefit in a randomized frontline clinical trial for this patient population, with a final overall survival readout showing continued improvement in median overall survival across the trial through three different analyses that were conducted, starting first with the original Phase II clinical trial data readout in July of 2024, which was across all endpoints. The median overall survival benefit was reported as 11.1 months. The median overall survival improvement observed in the subsequent Clinical data readout in December 2024 was 13 months. And as we disclosed, this week has now expanded to 14.7 months in the final review of the trial results. Moreover, patients treated with PARP inhibitors as maintenance therapy, in addition to Immune 101 and standard of care chemotherapy, demonstrated a median increase in overall survival of more than two years. The timing of this final analysis was defined in the protocol to occur when the last patient enrolled in the trial had reached three years post-treatment. And these truly unprecedented Phase II results have given our laser-focused execution of the ongoing rigorous Phase III trial, which was as agreed to with FDA, is designed to confirm the Phase II results and support full regulatory approval. Throughout 2025, we showcased the strength of these Phase II clinical data and the compelling translational insights at major scientific forums highlighted by the platform presentation at the 2025 ASCO Annual Meeting and the simultaneous publication of the Evasion II study results in the peer-reviewed journal, Gynecological Oncology. We capped off the year with a highly successful R&D day we hosted in November in New York City, and the investment community and leading clinicians heard directly from key opinion leaders about Immunon's ability to turn immunologically cold tumors hot, to remodel the tumor microenvironment, and deliver meaningful clinical survival benefits to women with newly diagnosed advanced ovarian cancer where none had existed before. This momentum carried into 2026 with Ovation 3 trial enrollment well ahead of plan. In a protocol that is virtually identical to the Phase 2 study, Ovation 3 is a one-to-one randomized trial to evaluate iminon-001 plus standard of care neoadjuvant and adjuvant chemotherapy, which includes interval debulking surgery, versus the standard of care alone in women with treatment-naive advanced ovarian cancer. The adaptive trial design with interim analyses for early efficacy stopping rules provides 95% power on the primary endpoint of overall survival while offering the potential for accelerated timelines of a BLA for full approval. Key updates since our Q3 2025 results conference call underscore the strength of our phase two foundation, and the accelerating progress in phase three, based on the strong response from patients, our clinical trial investigators, and the broader medical community. And I'll just highlight a few areas, starting with site activation status. Phase three trial enrollment remained strong with seven clinical sites actively enrolling patients, and up to 43 additional high-quality centers under evaluation or in startup mode. Returning investigators from the Ovation 2 study have been joined by new top tier centers, many proactively reaching out following our data presentations and publications. We have contracted a global CRO to support rapid advancement of phase three trial site activation and the study overall. Turning to enrollment velocity. Building on the strong progress we reported in late 2025, patient randomization and treatment in the phase three trial have continued at an impressive pace, and enrollment remains ahead of plan. The early sites have delivered higher than the assumed rate of 0.3 patients per month, with some sites delivering as high as one patient per month. This early momentum driven by the compelling Phase 2 study overall survival benefit positions us well for continued acceleration of site activation and patient enrollment. Our goal is to have approximately 80 patients enrolled in the trial within the next 12 months and enrollment completed in 2029. Turning to regulatory and design validation, based on the FDA's endorsement of overall survival as the primary endpoint of the Phase 3 trial combined, With a robust statistical framework and precedent in oncology clinical drug development, Ovation 3 continues to de-risk the path to a potential regulatory approval in both the U.S.