Imunon, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Thank you, operator, and good morning.

Welcome to the Imunon second quarter 2026 financial results and business update conference call. Joining us today are Stacy Lindborg, President and Chief Executive Officer, Dr. Douglas Faller, Chief Medical Officer, and Josh Blacher, Chief Financial Officer. Michael Tardugno, the company's Executive Chairman, is also on the line for the Q&A portion of today's call. Before we begin, I'd like to remind everyone that our remarks today include forward-looking statements. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include, but are not limited to, statements regarding the timing and enrollment of the company's clinical trials, the potential of the company's therapies to address unmet medical needs, the market potential for its product candidates if approved, and the company's plans and expectations for its development programs.

Words such as may, will, expect, plan, anticipate, estimate, and intend identify these forward-looking statements, and actual results may differ materially from those projected. Additional information on the factors that could cause actual results to differ is detailed in Imunon's filings with the Securities and Exchange Commission, which are available at sec.gov and on the company's website. Forward-looking statements made on the call speak only as of today's date, and the company undertakes no obligation to update them except as required by law. With that, I'd now like to turn the call over to Dr. Stacy Lindborg.

Stacy, please go ahead. Thank you, Valter, and good morning, everyone.

Thank you for joining us today and for your continued support of Imunon. The second quarter marked another period of focused execution and key validation of both IMNN-001, our lead asset, and our TheraPlas platform. Across our clinical programs, we continued to demonstrate the strength of our data, which is earning growing recognition within the scientific community while remaining disciplined in our execution. Our North Star remains unchanged. Bring a much-needed new treatment option to women with advanced ovarian cancer, a disease that affects approximately 300,000 women worldwide each year, has a 5-year survival rate of roughly 40%, and has seen little meaningful advancement in the standard of care for nearly three decades.

Before we dive into this quarter's progress, I want to invite our investors and members of the media to join us for our R&D Day on September 23rd in New York City. We look forward to providing a deeper look at the science behind IMNN-001, the progress we've made, and the opportunities that lie ahead. Now onto the second quarter. I will begin by highlighting three themes that have shaped this quarter. First, the continued validation of our technology and platform. Second, the strong pace of enrollment in our pivotal Phase III OVATION 3 study. Third, the disciplined financial and operational execution across our company as we maintain focus and remain focused on advancing our Phase III clinical trial. First up, continued validation of our technology and platform.

Turning to the clinical foundation that underpins everything we are doing, the final data from our completed Phase II OVATION 2 study, which continues to strengthen our conviction in IMNN-001. Across successive analyses, we have observed a consistent and clinically meaningful improvement in median overall survival. Most recently, 14.7 months in the intention to treat an all-comers population of newly diagnosed patients. This alongside a highly favorable safety and tolerability profile that successfully addresses the historic barriers associated with systemic IL-12. Complementary translational findings, including lower rates of minimal residual disease, higher circulating tumor DNA clearance, and encouraging rates of no evidence of disease following frontline therapy further reinforce the biological activity of localized durable IL-12 expression at the tumor site. These consistent clinical and translational signals give us high confidence as we advance the pivotal Phase III program.

Staying with the first theme and really focusing more on the additional validation that comes through our Phase II MRD or minimal residual disease trial. As a reminder, in July, we reported encouraging preliminary data from this trial. The study is being conducted in collaboration with Break Through Cancer and is led by investigators at The University of Texas MD Anderson Cancer Center. The study is designed not only to evaluate clinical activity, but also to better understand how IMNN-001 remodels the tumor immune microenvironment following frontline treatment. Among patients who had reached the study's primary assessment and endpoint of second-look laparoscopy, treatment with IMNN-001 was associated with a lower rate of MRD positivity compared to the control arm, 44% versus 67%.

It was associated with a higher circulating tumor DNA clearance with Imunon arm 87.5% versus 62% in the control arm, and a higher proportion of patients achieving no evidence of disease following frontline therapy, which was 100% in the Imunon treatment arm versus 56% in the control arm. While these are preliminary findings from a small cohort, they provide encouraging evidence of deeper antitumor activity for IMNN-001. The translational analyses continue to support IMNN-001's proposed mechanism of action. We observed robust IL-12 expression within macrophages, activation of downstream cytokines, including the FDA-endorsed potency assay, interferon gamma. We observed evidence of both macrophage and T cell activation consistent with remodeling the tumor microenvironment from an immunologically cold state to one that is immunologically active or hot. Finally, these encouraging biological and clinical findings continued to be accompanied by a highly favorable safety profile.

Across the MRD study, which is also true more broadly, we have observed no cytokine release syndrome, no systemic toxicities, and no serious immune-related adverse events, further reinforcing our belief that IMNN-001 has successfully overcome the historic safety challenges associated with IL-12-based therapies. Enrollment momentum in phase III and turning to our lead phase III asset, we remain very encouraged by the continued pace of enrollment in our pivotal OVATION 3 study. The trial continues to generate strong engagement from investigators and patients, reflecting the strength of the data generated in OVATION 2, which includes a well-established safety profile and compelling overall survival and efficacy results that we believe are unlike anything previously reported in the setting. Operationally, the team has executed with discipline and speed.

From protocol finalization through site activation and first patient enrollment, we have moved at a pace meaningfully faster than industry benchmarks for phase III study startups. Enrollment rates are exceeding our internal assumptions, with the majority of activated sites performing at or above plan. This momentum reflects the strength of our data and the enthusiasm of investigators at leading cancer centers that are involved in our trial. Combined with the efficiencies gained from our sharpened organizational focus in in-house manufacturing, we are demonstrating the operational excellence required to advance a late-stage program of this importance. With that, I'll turn the call over to Dr. Douglas Faller, our Chief Medical Officer, who can expand on these data and offer perspective on the phase III progress in more detail.

Douglas? Thank you, Stacy. As Stacy mentioned, OVATION 3 is our pivotal phase III trial evaluating IMNN-001 in combination with standard of care neoadjuvant and adjuvant chemotherapy in patients with newly diagnosed advanced epithelial ovarian cancer.

We continue to be very encouraged by the trial's execution and momentum. Site activation has proceeded efficiently, and enrollment continues to exceed our planned assumptions. We are currently enrolling approximately 0.5 patients per site per month compared with the 0.3 patients per site per month assumed in our trial plan, and compared with historical ovarian cancer study rates of about 0.2 patients per site per month. From a clinical perspective, we believe this enrollment trend reflects several factors.