Imunon, Inc.

Hello everyone. Good morning. My name is Mello and I will be your operator today. At this time, I would like to welcome you to Immunon's third quarter 2024 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. At that time, you might press star and one on your phone to ask a question. 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, let's start and want to ask a question during the Q&A session. I would now like to turn the call over to Kim Golodetz. Please go ahead.

Thank you and good morning, everyone. This is Kim Golodetz with Alliance Advisors IR. Welcome to Immunon's third quarter 2024 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 expect, 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. Sorry. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, November 7th, 2024. 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, Kim, and good morning, everybody. I'd like to begin by noting that Michael Tardigno, the Executive Chairman of our Board, and Krishid Anwar, our Chief Scientific Officer, are both on the line and will be available for Q&A. David Gallero, our Interim Chief Financial Officer, will review our financial results following my remarks. Let me start with a punchline and a groundbreaking milestone for Immunon. On July 30th, we announced the results from our large randomized phase two study, Ovation 2, which has the potential to set a new standard in cancer research. This large randomized study involving 112 newly diagnosed patients with advanced ovarian cancer not only exceeds expectations, but also marks an unprecedented achievement in oncology. An improvement in median overall survival 11.1 months, nearly a year compared to the standard of care, a clinically meaningful and unprecedented improvement in first-line treatment. For women who were administered PARP inhibitors in the Immunon arm, the median overall survival was not yet reached at data lock, indicating that more than half of the patients in the Immunon arm are still with us, with some women approaching the five-year mark since trial initiation. Importantly for those receiving at least 20% of the planned Immunon 001 doses, survival increased by a remarkable 17 months. These outcomes are particularly significant in a patient population that has not witnessed an advancement in frontline therapy, which extends patients' lives for over 25 years. More crucially, Ovation 2 is the first study ever to demonstrate an improvement in overall survival in this context. For a deeper dive and to better understand these outcomes, I encourage you to visit our Ovarian Cancer R&D Day presentation from September 18th. which is available on our website under the News and Investors tab and then Scientific Presentations. This R&D day features insights from studies, principal investigators, esteemed thought leaders, and distinguished Harvard statistics professor and a former NIH and National Cancer Institute IL-12 researcher. Their endorsements are compelling, and a testament to the significance of the Ovation 2 results. You can listen to the entire program or target specific talks, and I promise it will be well worth your attention. We also announced today the presentation of additional data from Ovation 2 study at the Society for Immunotherapy of Cancer, or CITC, the 39th annual meeting taking place in Houston, Texas. The Ovation 2 results were so compelling that they accepted our presentation as a late-breaking poster at the meeting after the deadline had passed. Results are being presented at the meeting tomorrow by Dr. Jennifer Scalise from Emory University of Medicine, the School of Medicine. This is an exceptional opportunity to build awareness and broader awareness of Immuno-01 and our Phase II trial results. among peers and experts in the oncology field. Drilling into the data further, we observed consistent benefits in the trial across multiple study endpoints. This includes an early treatment effect as shown by progression-free survival, chemotherapy response scores, surgical response scores, and most importantly, in a sustained way through overall survival. These data are all in the intent to treat population of 112 patients. We expect to report supportive translational data from the trial shortly. In summary, the clinically meaningful results with Immunona 01 are truly remarkable and consistent. Furthermore, the safety profile has been consistently benign and easily managed. The unmet patient need is very high. This is a terrible and difficult to treat cancer, with more than a quarter million women diagnosed with the disease globally each year. In the U.S., there are more than 20,000 new diagnoses and about 13,000 deaths every year. Ovation 2 accomplished the desired outcome, and we know the data were sufficiently strong that our scientific advisory board unequivocally recommends proceeding to a registration phase three trial. with the dose studied in phase two. The support of the scientific advisor award was unanimous and unwavering. On a commercial note, our prospective product pricing assumptions suggest a U.S. market opportunity for ovarian cancer that exceeds 1.6 billion annually, which is far greater as we consider other geographies and clearly in blockbuster territory. We've been saying all along that the Phase II outcome was not unexpected. Ovation 1, a Phase I study in the same population, demonstrated unambiguously through translational data that our TheraPlas technology works. The trial showed immunodriven increases in anti-cancer cytokine levels, such as IL-12 and interferon gamma, and decreases in immunosuppressant biomarkers. such as FOXP3, PD-1, PD-1L, and IDO1. In fact, the breadth of translational data from this trial is more than I can highlight given our time today, and I would encourage you to explore them further through the Ovation 1 manuscript. In short, Ovation 1 provides evidence that TheraPlas works by effectively recruiting the patient's own immune system to fight cancer. Ovation 1 also provides a dose-dependent trend in clinical improvement and an acceptable Immunon safety profile with virtually no overlapping toxicity with chemotherapy treatments. For those who follow Immunon closely, you know that what makes Immunon-001 unique is the THERAPLUS technology. Immunon-001 is a non-viral gene therapy which delivers IL-12 directly into the microtumor environment, causing multiple fold increases. and interferon gamma and those of other important cytokines. And furthermore, producing never yet before seen overall survival data. The gene delivery at the tumor site minimizes the toxicity that others have seen with systemic IL-12 injections. And our approach has unlocked the door to new treatment frontiers with IL-12 and is generating new hope for patients with ovarian cancer. Turning to the concept of statistical significance, I want to highlight for just a moment the presentation at our R&D day by Dr. L.J. Wei of Harvard University. Dr. Wei pioneered a statistical approach that combines information across study endpoints for a more comprehensive evaluation of our treatment. He published this method in journals such as New England Journal of Medicine and JAMA, specifically with the methodology applied to oncology studies. If you're short on time, I suggest you prioritize Dr. Wei's presentation. He independently analyzed Ovation 2 data, combining information from two Kaplan-Meier curves, progression-free survival and overall survival, calculating the area under the curve and generating the average time lost due to both undesirable events, ovarian cancer, which would be cancer progression and death. Dr. Wei's approach has also been successfully used in cardiology and other additional cancer studies. And the end result of his analysis showed that iminona O1 had a reduction in the area under the curve with a significant p-value of 0.0375. His analysis provided statistical evidence that the effect observed in ovation 2 is likely to be driven by true treatment effect. His analysis gives us added confidence in the ability to replicate Ovation 2 findings in Phase 3. So where are we with respect to advancing the development of Immunon-001? Interactions with FDA are proceeding well, and we have asked the agency for an end of Phase 2 meeting and will meet with them before the end of the month. Assuming an agreement with the agency, we remain on track to begin our Phase III registration trial in the first quarter of 2025, and we are carefully identifying the requisite capabilities. As we are planning it, we expect that the Phase III trial will enroll approximately 500 women with advanced ovarian cancer and will evaluate iminon-001 in the study design that's very similar to Phase II. Inclusion criteria are likely to include newly diagnosed patients of at least 18 years of age that are candidates for neoadjuvant chemotherapy with histological evidence of epithelial, ovarian, fallopian tube, or primary peritoneal carcinoma with stage 3C and 4, and a performance score of 0, 1, or 2 by Eastern Cooperative Group, or ECOG, criteria. The primary endpoint is expected to be overall survival, but of course, the final protocol will be finalized with guidance from the FDA. Now to the ongoing MRD study, which is principally funded by the Breakthrough Cancer Foundation. The study is evaluating iminon-001's potential to eliminate minimal residual disease, or MRD, as determined by second look laparoscopy. We're studying this when iminon O1 is administered in combination with bioequivalent Avastin and NA-CT in subjects newly diagnosed with advanced ovarian, flipping tube, or primary peritoneal cancer. MRD is prognostic for cancer recurrence and as an endpoint may be able to determine the impact of treatment early in the disease. An update on the study was provided by the study principal investigator, Dr. Amir Jazari, of MD Anderson Cancer Center at our recent ovarian cancer R&D day. The study recently added additional clinical trial sites including Memorial Sloan Kettering Cancer Center and Johns Hopkins University. And as the first few patients have now reached second look laparoscopy, Dr. Daziri will conduct a pilot study to test circulating tumor DNA levels in plasma and peritoneal fluid following treatment using a next generation DNA assay. The goal is to determine the impact of both iminon and bioequivalent Avastin on MRD, understanding that positive MRD patients have worse outcomes. Switching topics, let's now turn to the phase one proof of concept study for iminon 101, which utilizes our Placine platform as a seasonal COVID-19 booster vaccine. During the second quarter of 2024, we began enrolling participants in the study, which is now fully enrolled and all treatments completed. We believe the anticipated immunogenicity data, along with superior handling logistics of the Plastine platform, differentiate our vaccine. And we are on track to complete phase one and report data before the end of the year. We've kicked off BD activities and will actively seek a partner to continue development. Recall this trial was not intended to move forward a vaccine in COVID, but instead to serve as a vehicle to efficiently demonstrate proof of concept on this platform. With more than 80 new pathogenic viruses discovered since the 1980s, for the right partner, this is an exciting product that can proceed in a multitude of strategic directions. As we gear up for our phase three trial with Immunon 001 and report top line data from Immunon 101, we've made two strategic hires to fortify our capabilities. These appointments have been meticulously considered to address critical needs at this crucial juncture for Immunon. We hired Kristen Longabardi as Senior Vice President of Strategic Operations. Kristen joins us with over two decades of exceptional experience in enhancing business processes and operations across the biotech and pharmaceutical sectors. Most recently, she served as Vice President of R&D Quality Operations and Performance at Biogen. We expect Kristin to play a vital role in planning the conduct of the phase three study, making sure it stays on track and on budget. In addition, we hired Susan Aulog. As general counsel and corporate secretary, Susan brings a depth of legal acumen to our team with a background that includes senior counsel at Science 37 and various other senior legal roles. Our goals include partnering some of our products, for example, Immunon 101, and as in-house legal counsel, Susan will play an important role in ensuring the soundness of any agreement we enter into, while also reducing the extraordinary legal cost burden typically incurred in the biotech industry. And now I'd like to turn over the call to Dave Gallero, to review our financial results for the third quarter and year to date. Dave?