Imunon CEO says company ‘has never been stronger’

In a letter to shareholders, CEO Stacy Lindborg said, in part, “As I mark my first year as President and CEO of IMUNON (IMNN), I am thrilled to share the progress we have made in advancing our mission to transform cancer treatment. With robust fundamentals and groundbreaking clinical data, your company is well positioned to deliver an innovative therapy and to create significant value for you, our shareholders. Over the past year, we have achieved remarkable milestones, most notably with our lead candidate, IMNN-001, which has entered the pivotal Phase 3 OVATION 3 Study for the frontline treatment of women newly diagnosed with advanced ovarian cancer. The Phase 2 OVATION 2 Study has demonstrated powerful and highly encouraging results, positioning IMNN-001 as a potential advance in the standard of care. Key findings, that will be presented tomorrow, June 3, in an oral presentation at the prestigious American Society of Clinical Oncology Annual Meeting and are also being published simultaneously in Gynecologic Oncology, include: Significant Survival Benefits: In the intent-to-treat population, IMNN-001 plus standard-of-care neoadjuvant and adjuvant chemotherapy extended median overall survival by 13 months compared to standard-of-care N/ACT alone, with a hazard ratio of 0.69. As Dr. Premal H. Thaker, OVATION 2 Study Chair and Interim Chief of Gynecologic Oncology at Washington University School of Medicine, noted, “An increase in survival of six months is considered clinically meaningful. The data indicating that IMNN-001 could extend lives by one year or longer represent a potentially historic advance.” Enhanced Efficacy with PARP Inhibitors: For patients receiving poly ADP-ribose polymeraseinhibitors as maintenance therapy, median OS in the IMNN-001 arm has not yet been reached after more than five years, with a hazard ratio of 0.38. Strong Results in HRD+ and BRCA Populations: Increased therapeutic activity was observed in women with homologous recombination deficiency, including BRCA1/2 mutations, with a hazard ratio of 0.42. Consistency of Clinical Data: Consistency, across multiple endpoints, subgroups and data analyses, suggest that the OS results are real and have great promise to be confirmed in our Phase 3 study, and particularly in the HRD+ and BRCA-mutated population where this important subgroup readout may occur much sooner than in the ITT population. Favorable Safety Profile: IMNN-001 was well tolerated, with primarily manageable adverse events and no reports of cytokine release syndrome, systemic toxicity, or serious immune-related adverse events, making it a promising first-in-class immunotherapy. Our dialogue with the U.S. Food and Drug Administration, to date, has not identified any fundamental weaknesses in our data, analyses or assumptions. Their alignment in support of our Phase 3 trial was quick and unambiguous. With these results, IMNN-001 becomes the first immunotherapy with a favorable safety profile to demonstrate survival benefits in a frontline setting leading to the potential to transform ovarian cancer treatment. The TheraPlas platform, which powers IMNN-001, leverages the immunological properties of interleukin-12 to target the tumor microenvironment effectively. These data further validate TheraPlas’ potential to treat ovarian cancer while alleviating side effects often seen with other immunotherapies. Beyond ovarian cancer, we are exploring IMNN-001 applications in other tumor types and TheraPlas’ ability to carry other therapeutic DNA payloads, both of which could unlock significant opportunities for growth and partnerships. Our clinical success has attracted increasing interest from institutional investors, reflecting confidence in our science and strategy. The recent upward trajectory in our share price positions us well to potentially meet the $1 NASDAQ listing requirement in the near term. As we prepare for the Phase 3 OVATION 3 Study, which will evaluate IMNN-001 in women with stage IIIC or IV ovarian cancer we are committed to funding this pivotal trial strategically. We have taken steps to conserve cash and align our critical needs with available capital on hand, while securing the resources needed to advance this potentially transformative therapy through optimal opportunities.”