Imunon, Inc.

Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to the Immunons First 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, then 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 one to ask a question during the Q&A session. I would now like to turn your call over to Peter Vazio of ICR Healthcare Investor Relations Representative for Immunon. Please go ahead.

Thank you, Dave. Good morning, everyone, and welcome to Immunon's first 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 such statements. I also caution that the content of this conference call is accurate only as the date of this live broadcast, May 12, 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 Lindbergh, President and Chief Executive Officer. Stay tuned.

Thank you, Peter, and good morning, everyone. Joining me on this call is Dr. Douglas Fowler, Immunon's Chief Medical Officer, and Dave Gallero, our Interim Chief Financial Officer, who will review our financial results for the first quarter of 2025. Michael Tardigno, the Executive Chairman of our Board, and Krishid Anwar, our Chief Scientific Officer, are also both on the line and will be available for Q&A. I want to start by saying that we may be close for the first time to unlocking the power of interleukin-12 to effectively treat cancer in one of the worst forms, ovarian cancer. Our work in developing treatments for ovarian cancer, a disease that continues to challenge scientists and clinicians, and researchers underscores our commitment to addressing unmet medical needs and driving long-term value. I'm amazed at the number of discussions I've had since joining Immunon in both personal and professional settings where people have shared impact from ovarian cancer at a close and personal level. Its devastation has no limits in taking the lives of women, young and old, in their prime. We continue to make significant strides towards our goal of transforming the treatment landscape for women diagnosed with advanced ovarian cancer. To that end, I'm pleased to report that we have initiated the first clinical site in our phase three pivotal study of Immuno-001. If the results from our highly successful phase two study are replicated in phase three, patients and doctors may potentially have a meaningful life-extending therapy that recruits and empowers body's immune system to effectively target this disease. Our phase three study, known as Ovation 3, is being recognized by the medical community as a critical step towards the goal of delivering a new frontline treatment for women with limited options and unmet urgent medical needs. This recognition is exemplified by the acceptance of our new Ovation 2 results for an oral presentation at the upcoming ASCO Annual Meeting and for publication in the peer-reviewed journal Gynecologic Oncology. It also underscores the scientific community's strong and historic evidence of Immunon-001's anti-cancer potential. We believe we have much to offer the future of oncology treatment, and I hope you are as excited as we are. Now, I'd like to report on our recent progress and review our clinical and regulatory status of ME-9001. We continue to work with our trial investigators to begin enrolling participants, all of whom have shown unwavering interest in the Phase III trial and are committed to advancing the study. The confirmatory phase three trial elevation three will assess the efficacy of Immunon-001 plus the standard of care versus standard of care, which is neoadjuvant and adjuvant chemotherapy alone. The standard of care for women who are newly diagnosed and treatment naive is paclitaxel and carboplatin chemotherapy, both neoadjuvant and adjuvant to interval debulking surgery. The study will enroll women at least 18 years of age, newly diagnosed with advanced ovarian cancer. Study participants will have been randomized, will be randomized one-to-one, and there will be a subgroup of women positive for homologous recombination deficiency, HRD, which, as many of you will know, includes the familiar mutations BRCA1 or BRCA2. Participants within this subgroup will receive PARP inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival, or OS. Secondary endpoints include surgical response score, chemotherapy response score, clinical response, and time to second-line treatments. The study will also assess several exploratory endpoints, including quality of life measures, which will aid as we engage in payer and pricing discussions in the future as we entertain approvals and access around the world. The advantage of overall survival as a primary endpoint is that it is a definitive endpoint. There will be no need for a second conformational study to support approval And if results are positive, the phase three trial is also expected to support EU registration as a direct result of the selection of overall survival as the primary endpoint. And you'll recall that we have orphan status established in Europe along with US orphan drug designation. The initial core set of clinical trial sites currently activating are highly encouraged by Immi901's data and are enthusiastic about Ovation 3. These include sites that were part of both the Phase 1 Ovation 1 study and the Phase 1 Ovation 2 study. And we're excited to bring new sites on board to accelerate enrollment of the trial. The strength of our data is the key point of discussion, and we believe it will drive surgeons' interest and patient recruitment. There is optimism that Immune 901 could potentially be a new product on the horizon and reset the standard of care for the frontline treatment of women newly diagnosed with advanced ovarian cancer if the safety and efficacy from evasion two are confirmed in phase three. We have a strategy and statistical plan which allows for a 500 patient trial in an all-comers population of newly diagnosed patients, as well as a plan to focus on a 250-patient subgroup, defined by a biomarker, identifying patients who are HRD-positive. Both are strong options and have 95% power or higher, and both are capable of supporting an FDA approval for Immuno-901. As we shared in our last call, we will focus initially on the HRD-positive subgroup defined by a biomarker through a central lab. This highly cost-effective strategy allows us to enroll half the number of patients with an opportunity to achieve a readout sooner. We expect the study budget will be approximately 40% lower than the full study budget and could read out two years earlier. This population represents one-half of the neoadjuvant ovarian cancer market and would be an important advancement for patients. We would likely trigger a broadening of the inclusion criteria at a later date, budget permitting, to reach the 500-patient all-comers trial. Our strategy includes an interim analysis at high probability for success milestones. As we advance Immunonta 01 in the phase 3 Ovation 3 trial, we do not want its achievements in Ovation 2 to go unnoticed. As previously announced, data from the Ovation 2 study will be reviewed in an oral presentation during ASCO's annual meeting next month. Dr. Premal Thakkar, who is interim chief of gynecologic oncology, the David and Lee Mulch Distinguished Professor of Obstetrics and Gynecology, also Director of Gynecologic Oncology Clinical Research all at Washington University School of Medicine. She will lead the discussion in the oral presentation. As I mentioned earlier, review of the full data from Ovation 2 will be published in a highly esteemed journal, Gynecologic Oncology, on June 3rd being released simultaneous to the ASCO presentation. Having our data presented in two of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer, as well as the strength and potential of Immunon's TheraPlas platform technology. With that, I'd like to turn the call over to Dr. Douglas Fowler, who will discuss the Phase 3 Ovation 3 study, including key points from his recent and ongoing discussions with study investigators as we initiate sites. Douglas?