Imunon (NASDAQ:IMNN) executives used the company’s fourth quarter and full-year 2025 earnings call to emphasize progress in the development of its IL-12 immunotherapy candidate IMNN-001 for newly diagnosed advanced ovarian cancer, while also outlining funding priorities and updated financial results.
OVATION 2 data show expanded overall survival benefit
President and CEO Dr. Stacy Lindborg highlighted what she called a “transformational year” in 2025, pointing to the company’s phase II OVATION 2 trial results as the foundation for its ongoing phase III program. Lindborg said the final overall survival (OS) review for OVATION 2 showed a 14.7-month improvement in median OS, compared with earlier analyses that reported 11.1 months (July 2024) and 13 months (December 2024).
Chief Medical Officer Dr. Douglas Faller said the OS improvement observed in OVATION 2 was “unprecedented in ovarian cancer,” adding that the company is focused on potential benefit for the broader newly diagnosed advanced ovarian cancer population, not only patients treated with PARP inhibitors.
Phase III OVATION 3 enrollment ahead of plan
Lindborg said IMNN-001 is advancing in the OVATION 3 pivotal phase III trial, which she described as a one-to-one randomized study evaluating IMNN-001 plus standard-of-care neoadjuvant and adjuvant chemotherapy (including interval debulking surgery) versus standard of care alone in treatment-naïve women with advanced ovarian cancer.
According to Lindborg, the adaptive trial design includes interim analyses with early efficacy stopping rules and is powered at 95% on the primary endpoint of overall survival, with the intent to support a biologics license application (BLA) “for full approval” on an accelerated timeline if interim criteria are met.
On trial operations, Lindborg said:
- Seven clinical sites are actively enrolling patients, with “up to 43 additional” centers under evaluation or in start-up mode.
- The company contracted a global CRO to support site activation and execution.
- Early sites are enrolling above the assumed rate of 0.3 patients per month per site, with some sites enrolling as high as 1 patient per month.
Imunon’s goal, Lindborg said, is to have approximately 80 patients enrolled within the next 12 months, with enrollment completion targeted for 2029.
Asked about interim analysis timing, Lindborg said the trial is designed with two interim analyses, and that the first interim is expected to occur after the trial is fully enrolled, “about a year after that,” based on simulations.
Faller added that while OVATION 3 is an open-label study, the company is blinded to efficacy data “to preserve data integrity,” though it is not blinded to safety.
MRD study capped at 30 patients; translational work ongoing
Lindborg discussed ongoing work from a phase II minimal residual disease (MRD) study being conducted in collaboration with Break Through Cancer. She said the MRD study has shown preferential uptake in peritoneal macrophages, tumor microenvironment remodeling, complete pathological responses, and durable IL-12 and interferon gamma expression, with “excellent tolerability” even in combination with bevacizumab.
The company has capped enrollment in the MRD study at 30 patients, Lindborg said, to meet its “core objectives” and to focus resources and sites on OVATION 3.
Faller said the MRD study has shown no dose-limiting toxicities and no discontinuations attributed to IMNN-001, along with “very encouraging trends” in progression-free survival and MRD negativity.
Regarding future updates, Lindborg said additional MRD disclosures in 2026 are possible, depending on discussions with the study principal investigator, Dr. Amir Dazari, and timing of potential medical meeting presentations.
On additional OVATION 2 analyses, management said the company plans further translational analyses and publications. Faller said this may include peripheral immune responses in addition to tumor and tumor microenvironment findings previously presented. He also said OVATION 3 will assess circulating tumor DNA, which could potentially emerge as an MRD-related marker in ovarian cancer, though it is not established.
Financing priorities, site expansion considerations, and cost actions
Lindborg said Imunon’s priorities in 2026 include funding the phase III trial, extending runway, and growing its institutional investor base. She described a “multi-pronged financing strategy” that includes targeted equity raises, ATM usage, warrant exercises, and partnership discussions, with an emphasis on minimizing dilution and securing long-term investors to fund OVATION 3.
Lindborg also noted potential non-dilutive partnerships related to the company’s TheraPlas platform and IMNN-001, and said the company has seen new partnership inquiries following the release of the final OVATION 2 data.
On costs, Lindborg referenced a strategic reorganization announced in February 2026 intended to reduce non-essential expenses and focus the organization on OVATION 3. In response to an analyst question, she characterized the restructuring as primarily a resource-allocation and focus initiative rather than driven by a single cost-savings figure.
On geographic expansion of OVATION 3 sites, Lindborg said enrollment efforts are currently U.S.-focused, while noting interest from Canadian sites and discussions with “leading sites in central Europe” as the company evaluates whether additional countries could accelerate enrollment.
She also said OVATION 3 is being paid for through conventional clinical trial site contracting, including start-up fees and per-patient fees, and that Imunon is structuring contracts to take advantage of standard-of-care reimbursement where applicable.
2025 financial results and cash runway
Interim CFO Jeff Church said Imunon ended 2025 with $8.8 million in cash and cash equivalents as of December 31, 2025, reflecting warrant exercise proceeds and targeted ATM usage. Church said the company projects that its cash balance, along with ongoing financial activities and cost-saving initiatives, extends its operating runway into the second half of 2026.
Church reported research and development expenses of $7.8 million in 2025, down from 2024, attributing the decrease to completion of OVATION 2, optimization of the MRD study, and focused spending on OVATION 3 manufacturing and startup activities. He said general and administrative expenses decreased 8% year-over-year due to streamlined operations and renegotiated commitments.
Net loss for 2025 was $14.5 million, or $6.83 per share, compared to $18.6 million, or $16.94 per share, in 2024. Church noted that share and per-share amounts reflect a 15-for-1 reverse stock split effective in July 2025 and a 15% stock dividend declared in the third quarter of 2025.
In closing remarks, Lindborg said the company believes it is “well-positioned for milestones that will create value inflection in 2026 and beyond,” citing phase III enrollment progress, the durability of phase II OS data, translational findings, and financial discipline.
About Imunon (NASDAQ:IMNN)
Imunon, Inc, a clinical-stage biotechnology company, engages in the development of immunotherapies and vaccines to treat cancer and infectious diseases. The company’s lead clinical program IMNN-001, a DNA-based immunotherapy for the localized treatment of ovarian cancer that is in Phase II clinical development. Its preclinical stage products include IMNN-101, a COVID-19 booster vaccine; IMNN-102 for the treatment of Lassa virus; and IMNN-201, a Trp2 tumor associated antigen cancer vaccine in melanoma.
