Imunon, Inc.

Good morning. My name is Dhawan and I will be your operator today. At this time, I would like to welcome you to Immunon's second quarter 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 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 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, Darwin. Good morning, everyone, and welcome to Immunon's second quarter 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 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, August 5, 2025. 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 Pollard, Immunon's Chief Medical Officer, and Ms. Kimberly Graper, our Interim Chief Financial Officer, who will review our financial results for the second quarter of 2025. Mr. Michael Chardugna, the executive chairman of our board, and Dr. Krishid Anwar, our chief scientific officer, are on the line and will be available for Q&A. I want to begin by reviewing our progress in harnessing the potential of Immunano-01, our gene-mediated IL-12 therapy, as an effective treatment for ovarian cancer, one of the most challenging forms of malignancies today. Our efforts reflect a deep commitment to unmet needs in oncology and to creating lasting value for patients and our stakeholders. The personal stories that I hear on an ongoing basis about the impact of ovarian cancer reinforce the urgency of our mission. It affects women across all ages and stages of life with profound devastation. Recall that the frontline ovarian cancer treatment landscape has not seen an improvement in the standard of care platinum-based chemotherapy in over 25 years. Furthermore, prior to the Ovation 2 study, there has never been an overall survival benefit observed in a frontline ovarian cancer clinical trial. In addition, and importantly, clinical data from Ovation 2 across all endpoints and key subgroups have shown a consistent outcome favoring imunon-001. And while not powered for statistical significance, our trial has shown unprecedented improvement in overall survival. Patients in the intent-to-treat population who were administered imunon-001 plus the standard of care neoadjuvant and adjuvant chemotherapy achieved a median increase in overall survival of 13 months compared to the standard of care alone. This is 46 months versus 33 months with a hazard ratio of 0.69, a 45% improvement. Use of PARP inhibitors as part of maintenance therapy further enhanced outcomes with median overall survival not yet reached in the Immunana O1 treatment arm after more than five years for many patients versus 37 months median overall survival in the control arm with a hazard ratio of 0.38. We are advancing rapidly and have great potential to redefine treatment for women with advanced ovarian cancer. I'm delighted to share that our phase three pivotal study of Immunon-001, which we refer to as Ovation 3, has had an impressive start This builds directly on the strong data from our Evasion 2 study, which was showcased in an oral platform presentation at the recent ASCO Annual Meeting and was simultaneously published in the peer-reviewed journal, Gynecologic Oncology. Should results from the Phase 3 trial replicate these Phase 2 results, Immunon-001 could offer a transformative immune system engaging therapy. that extends life meaningfully for patients. Ovation 3, our pivotal phaser trial, is gaining traction in the medical community as a vital advancement for frontline treatment in a population with few options. The ASCO presentation and gynecologic oncology publication validate the robust evidence supporting Immunon-001's potential. as evidenced by a couple of things. Number one, direct comments to the milestone that Ovation2 has delivered for ovarian cancer made in the Q&A portion of the live ASCO session. Number two, inclusion of Immunonda 01's results in ASCO's highlights by medical journalists. And finally, interest expressed by principal investigators around the world to participate in our phase three trial We are poised to contribute significantly to oncology's future, and I hope this excitement is shared. I'll now provide an update on recent progress with Immunon 001's clinical and regulatory status. Our collaboration with clinical investigators remains strong and clearly is visible by the high interest and commitment to enrollment. A standout achievement is the speed of our phase three launch. Industry benchmarks show an average of 28 weeks from protocol approval to enrollment opening, but we accomplished this in 15 weeks for evasion three, almost half of the time. This reflects our team's agility and both patient and investigator's enthusiasm. I want to congratulate Douglas and his team for this great start to the trial. To date, three sites have been activated, and we have randomized and treated our first patient last week. Lobation 3 evaluates imunon-001 combined with the standard of care neoadjuvant and adjuvant paclitaxel and carboplatin chemotherapy, which is administered before and after interval debulking surgery. And this is compared to the standard of care alone in newly diagnosed treatment-naive women 18 years of age or higher. with advanced ovarian cancer. Participants are randomized one-to-one, including a subgroup with homologous recombination deficiency, or HRD-positive status, including BRCA1 and BRCA2 mutations. And these women receive PARP inhibitors and maintenance therapy. The primary endpoint is overall survival, with secondary endpoints including surgical response score, chemotherapy response score, clinical response, and time to second-line treatment. Exploratory endpoints such as quality of life measures will inform future pricing and payer discussions globally. We believe overall survival as the primary endpoint provides a clear path to approval without needing a follow-up study. In addition, it supports potential European registration alongside our orphan designations in both Europe and U.S. The initial group of sites that will be activated this year, many from the prior Ovation 1 and Ovation 2 studies, are highly motivated by the data we have produced to date. We plan to expand enrollment with new sites, which we anticipate will boost recruitment, positioning Immunon 001 as a potential new standard if Phase 3 confirms Ovation 2 safety and efficacy. Our flexible strategy supports a 500 patient all comers trial or a 250 patient HRD positive subgroup, both with 95% power or higher on the primary endpoint for an FDA approval. We're starting the trial with a 250 patient HRD positive subgroup identified through central laboratory biomarker testing. which will reduce the cost by 40% and enable early stopping for efficacy for successful milestones. This population addresses half of the neoadjuvant population, and we may expand to the 500-patient all-comers population later, budget permitting. To keep Ovation 2's momentum alive amid Phase 3, the ASCO oral presentation delivered by Dr. Premal H. Thakkar and the simultaneous publication in Gynecologic Oncology, two preeminent platforms, highlight the need for new therapies and the promise of our TheraPlas platform. Preparing for these disclosures, we dove further into the Evasion2 data, and we discovered that in addition to unprecedented survival data and consistency of data with all clinical endpoints and key subgroups favoring Immunon-001, We learned that all patients in the experimental arm, those treated with Immunonda O1, remained progression-free during the treatment protocol, while progressions were observed in the control arm. I'll now hand the call over to Dr. Douglas Fowler, Immunonda's chief medical officer, to comment further on the excitement from the medical community from ASCO and to share insights on Ovation 3, including with the discussions that you're having with investigators during site activation and enrollment. Douglas?